Evaluation of blood glucose controlling efficacy of various oral hypoglycemic drugs in Type 2 diabetes mellitus patients: A prospective, randomized, and control study

Background: This study was conducted to evaluate the effect of various oral hypoglycemic agents in the control of plasma blood glucose levels among Type 2 diabetes mellitus (T2DM) patients. Aims and Objectives: This study is aimed to evaluate the blood glucose controlling efficacy of various oral hypoglycemic drugs in T2DM patients. Materials and Methods: This randomized and control study was conducted among the cases attending Department of General Medicine at Research cell of Chennai Medical College Hospital and Research Centre, during the period of June 2014 to July 2015. A total of 180 cases were randomly allotted to six groups. Group I was treated with Glibenclamide, Group-II was treated with Glibenclamide + Sitagliptin, Group-III was treated with Glibenclamide + Vildagliptin, Group-IV was treated with Metformin, Group-V was treated with Metformin + Sitagliptin, and Group-VI was treated with Metformin + Vildagliptin. Fasting, postprandial, and glycated hemoglobin (HbA1c) levels were assessed before and at 4, 8, and 12th weeks and the data were analyzed using Statistical Package for the Social Sciences. Results: Fasting and postprandial sugars were significantly reduced in Group V and Group VI during 4th, 8th, and 12th weeks. However, HbA1c levels were significantly reduced after 12 weeks of treatment in Group III, Group V, and Group VI. Conclusion: We conclude that metformin in combination with either Vildagliptin or Sitagliptin can help to reduce fasting, postprandial, and HbA1c levels (both in short-term and in long-term); however, Glibenclamide along with Vildagliptin could reduce only HbA1c levels (long-term alone).

Comparative evaluation of metformin & sitaformin in classic PCOS patients undergoing intracytoplasmic sperm injection: A randomized controlled pilot study

Background & objectives: Studies have shown that insulin resistance and hyperinsulinaemia play a major role in the pathogenesis of polycystic ovary syndrome (PCOS). Therefore, the use of insulin sensitizing drugs in the treatment of PCOS has attracted the attention of medicine and researchers. The aim of this study was to investigate the effects of sitaformin (sitagliptin/metformin) and metformin on the quality of oocyte and embryo in classic PCOS patients undergoing intracytoplasmic sperm injection (ICSI). Methods: Sixty patients of PCOS (25-35 yr) were randomly allocated into three groups (n=20, each group): a metformin-treated group (administered metformin 500 mg twice daily), a sitaformin-treated group (administered sitaformin 50/500 mg twice daily) and a placebo group. Participants in all the groups received the drug two months prior to the start of the ovulation cycle and treatment continued until the day of the oocyte aspiration. Results: Serum insulin and total testosterone levels decreaseed significantly after treatment in both the treatment groups as compared to the placebo (P<0.05). A significant decrease in the number of immature oocytes [MI + germinal vesicle (GV) stage] was observed in metformin and sitaformin groups as compared to the placebo. In addition, sitaformin group when compared to the metformin group showed a significant decrease in the number of immature oocytes (P<0.05). The number of mature and normal MII oocytes increased significantly in both the treatment groups compared to the placebo group (P<0.05). The number of mature and normal oocytes increased in sitaformin group in comparison to the metformin group, but the difference was not significant. There was a significant increase in the number of grade I embryos, fertilization and cleavage rates in the sitaformin group compared to the other groups (P<0.05). Interpretation & conclusions: This is the first study to compare the impact of sitaformin with metformin on oocyte and embryo quality in women with PCOS undergoing a gonadotropin-releasing hormone (GnRH) antagonist cycle. In conclusion, sitaformin can be more effective in decreasing immature oocytes and increasing the quality of embryos than the use of metformin.

Chromatographic study of sitagliptin and ertugliflozin under quality-by-design paradigm

Abstract The present study entails the systematic development and validation of a stability-indicating RP-HPLC method for the analysis of sitagliptin and ertugliflozin in a fixed-dose combination. Analytical quality by design (AQbD) concepts were used to define critical method variables, employing Pareto risk assessment and a Placket-Burman screening design, preceded by a Box-Behnken design with response surface analysis to optimise critical method parameters such as % acetonitrile (X1), buffer pH (X2) and column oven temperature (X3). Multiple response optimisation (Derringer's desirability) of variables was accomplished by studying critical analytical attributes, such as resolution, retention time and theoretical plates. The title analytes were separated effectively on a PRONTOSIL C18 column at 37 °C using a mobile phase of acetonitrile:acetate buffer, pH 4.4 (36:64 percent v/v), pumped at a flow rate of 1 mL/min, and UV detection at 225 nm. Linearity was observed over a concentration range of 25-150 µg/mL and 3.75-22.5 µg/mL at retention times of 2.82 and 3.92 min for sitagliptin and ertugliflozin, respectively. The method obeyed all validation parameters of the ICH Q2(R1) guidelines. The proposed robust method allows the study of the selected drugs in pharmaceutical dosage forms as well as in drug stability studies under various stress conditions.

Bullous Drug Reaction with Dipeptidyl Peptidase-4 (DPP-4) Inhibitors

Hypoglycemic drugs in the dipeptidyl peptidase-4 (DPP-4) inhibitor class are used as a second-line treatment for type 2 diabetes mellitus. With DPP-4 inhibitors, there have been a few reports of cutaneous side effects such as bullous response, fixed drug eruption, and photosensitivity. There is no definitive pathophysiology for the above mentioned allergic reactions. Sitagliptin phosphate belongs to the DPP-4 inhibitor class. This is a case report of a sitagliptin-induced bullous drug reaction manifesting three weeks after starting therapy. He had bullous pemphigoid-like eruptions all over the body. The patient showed improvement once sitagliptin was discontinued alon with oral and topical steroid treatment.

Effects of selegiline phosphate combined with liraglutide and osteoporotic triol on glucolipid metabolism and PINP and S-CTX levels in patients with T2DM combined with osteoporosis / 中华内分泌外科杂志

Objective:To investigate the effects of selegiline phosphate combined with liraglutide and osteopontin on glucolipid metabolism, bone mineral density and bone metabolism in patients with type 2 diabetes mellitus (T2DM) combined with osteoporosis (OP) .Methods:A prospective randomized controlled trial was designed.130 patients with T2DM combined with OP admitted to the outpatient clinic of Yantai Yantaishan Hospital from Jan.2020 to Aug. 2021 were selected as study subjects and pregrouped according to the pre-visit serial number according to the random number table method, 65 cases each. The control group weregiven liraglutide and osteopontin combination therapy, and the observation group were treated with sitagliptin phosphate combined with liraglutide and osteopontin, and both groups were treated continuously for 3 months. The tests compared the glycolipid metabolism [glycosylated hemoglobin (HAb1c) , triacylglycerol (TG) , fasting blood glucose (FBG) , total cholesterol (TC) , 2h postprandial glucose (2hPG) , high-density and low-density lipoprotein cholesterol (HDL-C, LDL-C) ], bone density [4 sites of femoral trochanter, lumbar orthostyle, femoral neck, forearm], before and after 3 months of treatment in the 2 groups. Changes in bone metabolism (osteocalcin (OC) , type I collagen C-terminal peptide (S-CTX) , 25-hydroxyvitamin [25 (OH) D], type I procollagen amino-terminal peptidogen (PINP) , and bone-specific alkaline phosphatase (b-ALP) ] levels were detected, and the adverse effects and efficacy of drug administration in the 2 groups were compared.Results:After 3 months of treatment, FBG (7.48±1.02) mmol/L, TG (2.01±0.31) mmol/L, PINP (43.72±4.86) ng/ml, HAb1c (7.43±0.65) %, S-CTX (0.27±0.09) ng/ml, 2hPG (9.08±1.34) mmol/L in the observation group, LDL-C (2.58±0.27) mmol/L were lower than those in the control group (7.86±0.97) mmol/L, (2.29±0.34) mmol/L, (46.55±4.19) ng/ml, (7.81±0.62) %, (0.32±0.10) ng/ml, (10.52±1.41) mmol/L, (2.89±0.31) mmol/L ( t=2.177, 5.968, 3.556, 3.481, 2.996, 5.968, 6.080, P<0.05) ; after 3 months of treatment, the bone density of each site in the observation group was (0.76±0.09) g/cm 3, (0.75±0.10) g/cm 3, (0.76±0.11) g/cm 3, (0.75±0.09) g/cm 3 and OC (20.87±2.33) μg/L, b-ALP (19.70±2.35) U/L were higher than those of the control group (0.70±0.10) g/cm 3, (0.68±0.09) g/cm 3, (0.69±0.10) g/cm 3, (0.70±0.10) g/cm 3, (18.45±3.66) μg/L, (18.09±2.14) U/L ( t=3.596, 4.195, 3.796, 2.996, 4.497, 4.084, P<0.05) ; the overall efficiency of the observation group was 96.92%, higher than that of the control group 84.61% ( χ2=5.876, P<0.05) . The difference was not statistically significant when comparing the incidence of adverse reactions in the 2 groups ( χ2=0.000, P>0.05) . Conclusion:Sitagliptin phosphate combined with liraglutide and osteopontin can further improve clinical efficacy and regulate glucolipid metabolism in patients with T2DM combined with OP, and it also has an important role in improving bone density and regulating bone metabolism level in patients.

Sitagliptin inhibits lipopolysaccharide-induced inflammatory response in human gingival fibroblasts by blocking nuclear factor-κB signaling pathway / 华西口腔医学杂志

OBJECTIVES@#This study was performed to clarify the effects of sitagliptin on @*METHODS@#Healthy gingival samples were collected from the donors. HGFs were isolated with enzymic digestion method and identified. The effects of LPS and sitagliptin on cell viability were detected by cell-counting kit-8 (CCK8). The mRNA levels of inflammatory cytokines, namely, interleukin (IL)-6, IL-8, C-C motif ligand 2 (CCL2), and superoxide dismutase 2 (SOD2), were evaluated by quantity real-time polymerase chain reaction (qRT-PCR) and enzyme-linked immune sorbent assay (ELISA) was used to measure the secretion protein levels of IL-6, IL-8, and CCL2. Western blot analysis was used to further investigate the activation of nuclear factor (NF)-κB signaling pathway. The effect of NF-κB pathway inhibitor BAY11-7082 on LPS-induced HGF inflammatory cytokines at the gene level was verified by qRT-PCR.@*RESULTS@#Low concentrations of sitagliptin (0.1, 0.25, and 0.5 µmol·L@*CONCLUSIONS@#Sitagliptin could significantly inhibit LPS-induced HGF inflammatory response by blocking the NF-κB signaling pathway activation.

Comparison of sitagliptin and acarbose in patients with type 2 diabetes mellitus complicated with sarcopenia / 中国医师进修杂志

Objective:To observe the changes of skeletal muscle indexes in elderly patients with type 2 diabetes complicated with sarcopenia treated with sitagliptin and acarbose.Methods:A total of 60 patients over 60 years old with type 2 diabetes complicated with sarcopenia in Dalian Municipal Central Hospital from January 2019 to January 2020 were selected and divided into two groups by random number table method.One group received sitagliptin and metformin,and the other group received acarbose and metformin. The changes of skeletal muscle indexes, glucagon-like peptides-1 (GLP-1), insulin resistance index (HOMA-IR) and inflammatory indexes were compared between the two groups at baseline and 36 weeks after treatment.Results:After treatment, the skeletal muscle index (SMI) of sitagliptin group was increased (5.94 ± 1.52 vs. 5.99 ± 1.52), and the difference was statistically significant ( P<0.05). Muscle strength and SMI decreased in acarbosse group (18.75 ± 4.64 vs. 17.72 ± 4.44, 6.09 ± 1.74 vs. 6.00 ± 1.71), with statistical significance ( P<0.05). GLP-1 increased in sitagliptin group, 0 min: (10.65 ± 1.68) pmol/L vs. (12.41 ± 1.88) pmol/L; 60 min: (22.79 ± 2.85) pmol/L vs. (25.51 ± 2.79) pmol/L; 120 min: (24.26 ± 2.94) pmol/L vs. (29.49 ± 2.91) pmol/L; 180 min: (11.68 ± 1.84) pmol/L vs. (12.88 ± 1.83) pmol/L. There were significant differences ( P<0.05). HOMA-IR and CRP decreased: 4.73 ± 3.04 vs. 3.16 ± 2.41, (2.39 ± 0.50) mg/L vs. (2.33 ± 0.43) mg/L, and the differences were statistically significant ( P<0.05). HOMA-IR in acarbose group decreased after treatment (5.80 ± 3.94 vs. 4.00 ± 1.63), and the difference was statistically significant ( P<0.05). Comparison between the two groups after treatment, the decreased value of muscle strength in sitagliptin group was less than that in acarbose group, and the difference was statistically significant ( P<0.05). GLP-1 and overall GLP-1 area under the curve in sitagliptin group were higher than those in acarbose group (67.64 ± 6.81 vs. 58.98 ± 6.72), with statistical significance ( P<0.05). HOMA-IR and CRP in sitagliptin group were lower than those in acarborose group: 3.16 ± 2.42 vs. 4.00 ± 1.63, (2.33 ± 0.43) mg/L vs. (2.41 ± 0.70) mg/L, with statistical significances ( P<0.05). Conclusions:Sitagliptin therapy improves muscle mass and protects muscle strength in elderly patients with type 2 diabetes mellitus and sarcopenia.

Evaluación de Sitagliptina para el tratamiento de pacientes adultos con diabetes mellitus tipo 2: revisión sistemática de costo-efectividad / Evaluation of Sitagliptin for the treatment of adult patients with type 2 diabetes mellitus: a systematic review of cost-effectiveness

Introducción: La diabetes mellitus tipo 2 es un problema de salud pública mundial y es una de las principales causas de mortalidad en Ecuador. La Sitagliptina fue el primer fármaco potenciador del sistema de las incretinas comercializado localmente. Los países no tienen recursos ilimitados para atender las necesidades de salud de su población, por lo que deben adoptar las intervenciones sanitarias más adecuadas, considerando los costos que un país pueda asumir y sostener. Objetivo: Sintetizar los resultados de estudios de costo-efectividad de la sitagliptina para el tratamiento oral combinado de pacientes adultos con diabetes tipo 2 en comparación con sulfonilureas. Metodología: Se realizó una revisión sistemática sin metaanálisis basado en las recomendaciones PRISMA. Los términos de búsqueda se estructuraron en base a la estrategia PICO y la pesquisa se realizó en las bases de datos: Pubmed, Tripdatabase y Pubmed Central para artículos de evaluaciones de tecnologías sanitarias, evaluaciones económicas y guías de práctica clínica, y para las políticas de cobertura se utilizó HTAiVortal y Google avanzado. Resultados: Se seleccionaron 3 ensayos clínicos y 8 revisiones sistemáticas-metaanálisis, 2 estudios de cohorte, 3 políticas de cobertura y 1 estudio de costo-efectividad. Tres revisiones sistemáticas establecieron pocos efectos modestos en cuanto a los efectos hipoglicemiantes de sitagliptina en adultos y adultos mayores; con un bajo riesgo de hipoglicemia. Un metaanálisis de 25 ensayos clínicos reportó mayor riesgo cardiovascular en los pacientes tratados con sitagliptina. Una revisión sistemática con evaluación económica mostró que la sitagliptina con metformina fue una alternativa costo-efectiva versus añadir una sulfonilurea o roziglitazona. Conclusiones: Por el perfil de costo-efectividad podría considerarse a la sitagliptina como segundo fármaco para pacientes que no consiguen control glicémico con dosis máximas de metformina, o en donde su asociación a una sulfonilurea no sea factible (por riesgos de hipoglicemia o adultos mayores).

Introduction: Type 2 diabetes mellitus is a global public health problem, being one of the main causes of mortality in Ecuador. Sitagliptin was the first locally marketed incretin-enhancing drug. Countries do not have unlimited resources to meet the health needs of their population, so they must adopt the most appropriate health interventions, considering the costs that a country can assume and sustain. Objective: To synthesize the results of cost-effectiveness studies of sitagliptin for combined oral treatment of adult patients with type 2 diabetes, compared with sulfonylureas.Methodology: This is a systematic review study without meta-analysis, conducted on PRISMA recommendations. The in-formation search was structured under the PICO strategy and the searches were conducted in Pubmed, Tripdatabase and Pubmed Central for articles on health technology evaluations, economic evaluations and clinical practice guides and for coverage policies HTAiVortal and advanced Google were used.Results: 3 clinical trials and 8 systematic reviews-meta-analysis, 2 cohort studies, 3 coverage policies and 1 cost-effectiveness study were selected. Three systematic reviews establish few effects regarding the hypoglycemic effects of sitagliptin in adults and elderly, with a low risk of hypoglycemia. A meta-analysis of 25 clinical trials reported an increased cardiovascular risk in patients treated with sitagliptin. A systematic review with economic evaluation showed that sitagliptin with metformin was a cost-effective alternative, versus adding a sulfonylurea or roziglitazone.Conclusions: Due to its cost-effectiveness profile, sitagliptin could be considered as a second drug for patients who do not achieve glycemic control with maximum doses of metformin, or where its association with a sulfonylurea is not feasible (due to risks of hypoglycemia or elderly).

Effects of treatment with sitagliptin on hepatotoxicity induced by acetaminophen in mice

Up to date, the management of hepatotoxicity induced by a suicidal or unintentional overdose of acetaminophen (APAP) remains a therapeutic challenge. The present study aimed to elucidate the potential effect of sitagliptin, a DPP-4 inhibitor, to ameliorate the acute injurious effects of acetaminophen on the liver. APAP toxicity was induced in mice by an intraperitoneal injection of APAP (400 mg/kg). The effect of treatment with sitagliptin, initiated 5 days prior to APAP injection, was evaluated. Serum indices of hepatotoxicity, oxidative stress markers in liver tissues, serum IL-1ß, and TNF-α in addition to hepatic- NF-E2-related factor-2 (Nrf2) were determined. Our results showed that APAP induced marked hepatic injury as evidenced by an increase in serum levels of ALT and AST, in addition to the deterioration of histological grading. Oxidative stress markers, serum TNF-α, and IL-1ß were also elevated. Sitagliptin successfully ameliorated the histological changes induced by APAP, improving liver function tests and liver oxidant status accompanied with a marked increase in Nrf2 level in hepatic tissues. Thus, the hepatoprotective effects of sitagliptin in this animal model seem to involve Nrf2 modulation, coincidental with its anti-inflammatory and antioxidant effects

A clinical investigational study on safety and effective management of type-2 diabetes mellitus patients by using sitagliptin

Background: To study the health and efficiency of the more up to date oral hypoglycemic specialist sitagliptin in the executives of sort 2 diabetes mellitus patients. In our examination authors have enlisted 250 patients who met our investigation criteria of which authors ordered dependent on age and lab information, most of patients in the age bunch between 45-55 years (n=97, 39.2%), the RBS was diminished to Comparatively estimations of RBS, FBS, PPBS, HbA1C were decreased in follow up than benchmark esteem.Methods: This simultaneous observational investigation was done when all is said in done department of General Medicine of Hi-Tech Medical College and Hospital, Bhubaneswar, Odisha for a time of 6 months in which type 2 diabetes mellitus patients were enrolled dependent on incorporation and avoidance criteria and were pursued to assess the adequacy and security of sitagliptin. Information was dissected by utilizing chart cushion crystal understudy T-test.Results: Authors can presume that sitagliptin use was not related with any dangers and is compelling in the board of Type 2 diabetics, treatment with sitagliptin gave clinically significant decreases in HbA1C, RBS, FBS, PPBS by utilizing this investigation authors realize that gliptins are considerably more protected and powerful in the treatment of sort 2 diabetes mellitus.Conclusion: Treatment with sitagliptin provided clinically meaningful reductions in HbA1C, RBS, FBS, PPBS by using this study authors know that sitagliptins are much more safe and effective in the treatment of type 2 diabetes mellitus.

Comparative Study of Metformin and Combination of Metformin and Sitagliptin in Type II Diabetic Mellitus Patients

Metformin is recommended as initial monotherapy for treatment of type 2 diabetes mellitus because it decreases the higher blood glucose by suppressing hepatic production of glucose, apart from suppression of hepatic glucose production, it also increases sensitivity of insulin, it also enhances the peripheral uptake of glucose (by inducing GLUT4 enhancer factor phosphorylation), and it also decreases the insulin-induced suppression of fatty acid oxidation. The aim of this study, metformin and combination of metformin and sitagliptin in type ii diabetic mellitus patients. Methods: Two groups were included in this study. Each group has 50 cases & each case was having diabetic mellitus. This study conducted in the Career Institute of Medical Sciences in the Department of Pharmacology. The duration of study was over a period of six month. Results: In our study we were included two groups. Each group has 50 cases, means total 100 cases were included. In group I we were observed 26 male & 24 female out of 50 cases. In group I we found that 13 had vomiting followed by diarrhea, metallic taste, abdominal pain. While in group II we found that 3 had vomiting followed by diarrhea, metallic taste, abdominal pain. Conclusion: The foregone discussion revealed that in patients who are on monotherapy with metformin alone having inadequate glycaemic control. The addition of one daily dose of Sitagliptin 100 mg is the most effective way of maintaining glycaemic control.

Enantiometric Separation Of Sitagliptin In A Fixed Dose Combination Formula Of Sitagliptin And Metformin By A Chiral Liquid Chromatographic Method

Objective: Sitagliptin phosphate and metformin hydrochloride tablet is an FDA approved combination product for the treatment of diabetes mellitus type 2. There are no reported evidence for estimation of undesired (S)-sitagliptin in a combination product. The objective of this study was to develop a high sensitive liquid chromatography method for the determination of (S)-enantiomer of sitagliptin phosphate in a fixed dose combination formula of metformin and sitagliptin. Methods: The proposed novel high-performance liquid chromatography (HPLC) method uses programmed gradient elution of a mixture of ethanol-diethylamine(DEA) 100:0.1 (v/v) as mobile phase-A and a mixture of methanol-water 60:40 (v/v) as mobile phase-B. The chromatographic conditions were designed to nullify the metformin interference and in which sitagliptin enantiomers elute first and followed by metformin. A satisfactory resolution (≥2.5) between (S)-sitagliptin and active form (R)-sitagliptin was achieved with gradient elution on Chiralpak IA column (5μm, 4 × 250 mm) at a flow rate of 0.5 ml/min and the detector wavelength set at 265 nm. The injection volume set as 10 µl. The developed method has been validated as per the International Conference on Harmonisation (ICH) guidelines. Results: The proposed HPLC method for determination of (S)-sitagliptin, showed good linearity in the concentration range of 0.5 µg/ml to 13.6 µg/ml and capable to quantify accurately up to the lowest level (LOQ) of 0.017%. The validated method was successfully applied to quantify the (S)-sitagliptin for different marketed formulations of sitagliptin with metformin and sitagliptin alone, and the corresponding recovery values were found to be in the range of 95.1% to 98.4%. Conclusion: The proposed validated HPLC method was found to be suitable for the quantitative determination of (S)-sitagliptin in the formulations of sitagliptin with metformin and sitagliptin alone.

Hypolipidemic effect of sitagliptin, voglibose and glimepiride in combination with metformin in patients with type 2 diabetes mellitus at a tertiary care teaching hospital: a comparative study

Background: The prevalence of coronary artery disease has been increased in diabetic dyslipidemia; hence the present study would like to compare the dyslipidemic effects of Sitagliptin, Voglibose, and Glimepiride in combination with Metformin in type 2 diabetes mellitus patients.Methods: This study was a Prospective, Randomized Clinical trial conducted at SRM medical College Hospital and Research centre. Potheri, Kancheepuram District in diabetic outpatient department after obtaining approval from Institutional Ethics Committee. The patients receiving antidiabetic drugs were divided into three groups. Patients received Metformin with Sitagliptin were grouped as I, Metformin with Voglibose were named as Group II and Metformin with Glimepiride were marked as Group III. Based on the inclusion and exclusion criteria, in each group, 40 patients were assigned as per simple randomization method. The level of lipid profile and BMI was evaluated at the end of 6 months.Results: There was a significant reduction of Total Cholesterol (TC) in Group II and Group III (p value- <0.001, <0.006). Group I showed significant elevation of HDL-C level with the p value of <0.03. Group III showed significant reduction of Triglyceride (TG) level with the p value of <0.04, significant reduction of Low Density Lipoprotein Cholesterol (LDL-C) level with the p value of <0.02 and significant reduction in Very Low Density Lipoprotein Cholesterol (VLDL-C) level with the p value of <0.05. There was no significant reduction in Body Mass Index (BMI) among the groups. On multiple comparisons, Group III showed higher efficacy in reducing TC, TG, LDL-C and VLDL-C levels.Conclusions: The results of this study were analysed and it could be concluded as Metformin with Glimepiride combination (Group III) showed significant reduction of TC, TG, LDL-C and VLDL-C levels.

Effect of Sitagliptin on Diabetic Profile of Type 2 Diabetes Mellitus Patients

Introduction: Time since death is an important topic that playsmajor role in forensic medicine. The accurate determinationof time since death is found to be helpful in medico legalinvestigation. Advancements in the methods for estimatingtime since death have enabled us to determine post-morteminterval more precisely. Since the 1850s, scientists have beenworking on different methods to determine post-morteminterval. Hence, the aim of the present study was to assess thetime since death using method of rigor mortis in the autopsiesdone at the mortuary of Osmania General Hospital.Materials and Methods: About 500 medico-legal autopsieswere selected where the exact time of death was known andthe body had been kept at prevailing room temperature. Agood quality digital hygrometer was used to note the dailyreadings of temperature and humidity. Presence or absence ofrigor mortis and its extent was noticed in both voluntary andinvoluntary muscles.Results: More unnatural deaths are in suspiciouscircumstances are occurring in males when compared tofemales. The average duration for onset of rigor mortis was 8hours and 39 minutes. The minimum duration in which rigormortis had begun to appear in the body was 1 hour and 35minutes while the longest maximum by which rigor mortishad not completely appeared in the body was 24 hours.Conclusion: Rigor mortis has been used for assessment oftime since death from long time. It is considered to be themost important and interesting method to estimate the timesince death.

Are dipeptidyl peptidase-4 inhibitors effective and safe in long term when added to ongoing therapies of diabetics? a real-life study in tertiary referral center

Background: The aim of this study was to determine how HbA1c, lipid, renal functions and such parameters were affected in the long term by adding dipeptidyl peptidase-4 inhibitors to the ongoing treatment regimens of patients with Type 2 diabetes mellitus.Methods: The study was conducted in diabetes mellitus outpatient clinic of Kayseri Training and Research Hospital between February 2012 and May 2017, with patients who did not achieve the sufficient success in diabetes their controls at the time of admission. From these patients, those who added (dipeptidyl peptidase-4 inhibitors) to their treatments were selected. Patients were followed up as long as they continued to these new treatments and the parameters at the baseline were compared with final values.Results: A total of 80 diabetic patients were followed in the study. The median age of the patients was 56.08±9.71 years. During this follow-up, an average decrease of 1.03% was noted when patients were compared with 9.53±1.87% of the initial hemoglobin A1c, and 8.50±1.48% of the Hemoglobin A1c values at the end of follow-up. This decrease was statistically significant (p <0.001). However, differences in the initial and final values of the lipid parameters of the patients were not statistically significant.Conclusions: Addition of dipeptidyl peptidase-4 inhibitors to patients' treatments causes significant decreases in Hemoglobin A1c mean values. This decline is long lasting. However, there are no positive or negative effects on biochemical parameters such as lipids, kidney and liver functions.

Sitagliptin in Achieving Better Glycemic Control as added Drug Therapy in Type 2 Diabetes Mellitus

Introduction: Type 2 diabetes mellitus is progressive loss ofglycemic control over a period of time. So the purpose of thepresent study was to evaluate the effectiveness and safety ofthe Sitagliptin as an ‘add-on’ to the ongoing drug therapy inpatients with Type 2 Diabetes Mellitus (T2DM).Material and Methods: It was a randomized, retrospectivepopulation based cohort study done in 259 patients for 36weeks from July’12 – March’13. Patients were randomlydivided into 2 groups. In 1st group, sitagliptin was added andno ongoing drug was withdrawn while in 2nd group sitagliptinwas added and dose of ongoing therapy was reduced to half.Results: The primary efficacy endpoint was reduction inglycated haemoglobin (HbA1C), fasting blood sugar, and 2hour post prandial blood sugar evaluated after 4, 8, 12, 18 and36 weeks. A better glycemic control was observed in 1st groupthan 2nd. Sitagliptin was well tolerated without side effects.Conclusion: Addition of Sitagliptin 100mg once daily as‘add-on’ drug therapy was well tolerated with significantglycemic control in T2DM after 36 weeks.

Comparison of clinical outcomes of sitagliptin+metformin combination and glimepiride in the management of uncomplicated type 2 diabetics

Background: To evaluate the comparison of clinical outcomes of sitagliptin +metformin and glimepiride in uncomplicated Type-2 diabetics.Methods: This one year (July 2016 to August 2017) prospective, open label, observational clinical cohort study was carried out on type-2 diabetics. In this study 299 Type-2 diabetics patients were enrolled and were randomly allocated to two groups viz Group A and Group B. Group A received sitaglitin+metformin (50+500) mg/day and Group B received glimepiride 1mg/day respectively. The follow up started after 10 days of stabilization of the patient and data recorded on 10th day was considered Zero month data and follow up continued up to Six month in each group. Comparison of FPG, PPG and HbA1c was evaluated between zero and six months within group and at six month between groups. Adverse events were recorded and summarized by treatment group.Results: At the end of six months follow up the patients of Group A who received sitaglitin+metformin (50+500) mg/day had greater reduction in FPG, PPG and HbA1c (all P<0.001) was recorded when compared between zero and six month within group. A significant reduction in FPG, PPG and HbA1c (all P<0.01) also recorded in Group B who received glimepiride 1mg/day when compared between zero and six months within group. A statically significant difference (all P<0.05) was recorded at six months between group. The adverse events like hypoglycemic episodes, gastrointestinal adverse events etc were greater in Group B than Group A. Changes in weight also noted in both Groups. Weight loss in Group A and weight gain in Group B was recorded.Conclusions: The present study suggests that a significant difference may be existing in the clinical outcome interm of glycemia control and adverse events between sitagliptin+metformin combination and glimepiride in type-2 diabetic patients.

Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

BACKGROUND: We evaluated the efficacy and safety of acarbose add-on therapy in Korean patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with metformin and sitagliptin. METHODS: A total of 165 subjects were randomized to metformin and sitagliptin (Met+Sita, n=65), metformin, sitagliptin, and acarbose (Met+Sita+Acarb, n=66) and sitagliptin and acarbose (Sita+Acarb, exploratory assessment, n=34) therapy in five institutions in Korea. After 16 weeks of acarbose add-on or metformin-switch therapy, a triple combination therapy was maintained from week 16 to 24. RESULTS: The add-on of acarbose (Met+Sita+Acarb group) demonstrated a 0.44%±0.08% (P<0.001 vs. baseline) decrease in glycosylated hemoglobin (HbA1c) at week 16, while changes in HbA1c were insignificant in the Met+Sita group (−0.09%±0.10%, P=0.113). After 8 weeks of triple combination therapy, HbA1c levels were comparable between Met+Sita and Met+Sita+Acarb group (7.66%±0.13% vs. 7.47%±0.12%, P=0.321). Acarbose add-on therapy demonstrated suppressed glucagon secretion (area under the curve of glucagon, 4,726.17±415.80 ng·min/L vs. 3,314.38±191.63 ng·min/L, P=0.004) in the absence of excess insulin secretion during the meal tolerance tests at week 16 versus baseline. The incidence of adverse or serious adverse events was similar between two groups. CONCLUSION: In conclusion, a 16-week acarbose add-on therapy to metformin and sitagliptin, effectively lowered HbA1c without significant adverse events. Acarbose might be a good choice as a third-line therapy in addition to metformin and sitagliptin in Korean subjects with T2DM who have predominant postprandial hyperglycemia and a high carbohydrate intake.

Efficacy and safety of sitagliptin added to metformin and insulin compared with voglibose in patients with newly diagnosed type 2 diabetes

OBJECTIVE: To assess the efficacy and safety of sitagliptin compared with voglibose added to combined metformin and insulin in patients with newly diagnosed type 2 diabetes (T2DM). METHODS: In this 12-week prospective, randomized, parallel trial, 70 newly diagnosed T2DM patients with glycosylated hemoglobin (HbA1c) ≥9% and/or fasting plasma glucose (FPG) ≥11.1 mmol/L were randomized (1:1) to receive sitagliptin 100 mg per day + metformin + insulin glargine or voglibose 0.2 mg three times daily + metformin + insulin glargine. Change in HbA1c at week 12 was the primary endpoint. RESULTS: The mean baseline HbA1c was 11.0% in the patients. The changes in HbA1c from baseline were -6.00% in the sitagliptin group and -3.58% in the voglibose group, and the between-group difference was -2.42% (95% CI -1.91 to -2.93, p=0.02). The differences in FPG and homeostatic model assessment of β-cell function (HOMA-β) and the change in body weight between groups from baseline were -2.95 mmol/L (p=0.04), 43.91 (p=0.01) and -2.23 kg (p=0.01), respectively. One patient (2.9%) in the sitagliptin group and three patients (8.6%) in the voglibose group exhibited hypoglycemia. CONCLUSIONS: Sitagliptin added to combined metformin and insulin therapy showed greater efficacy and good safety regarding hypoglycemia in patients with newly diagnosed T2DM compared with voglibose.

Efficacy and safety of hydroxychloroquine when added to stable insulin therapy in combination with metformin and glimepiride in patients with type 2 diabetes compare to sitagliptin

Background: The trial was done to evaluate the efficacy and tolerability of hydroxychloroquine when added to stable insulin therapy in combination with metformin and glimepiride in patients with type 2 diabetes (T2DM) compare to sitagliptin.Methods: After two weeks run in period, eligible patients inadequately controlled on long acting, intermediate acting or premixed insulin (HbA1c ?7.5% and ?10%), in combination with metformin and glimepiride were randomised 1:1 to the addition of once daily hydroxychloroquine 400mg or sitagliptin 100mg over 24weeks study period. The primary endpoint was HbA1c change from baseline at week 24. Home based glucometer was used to determine finger stick glucose value to detect hypo or hyperglycemia periodically.Results: At 24 weeks, the addition of hydroxychloroquine significantly (p <0.001) reduced HbA1c by 1.3% compared with Sitagliptin which was 0.9%. A greater proportion of patients achieved an HbA1c level <7% while randomised to Hydroxychloroquine as compared with sitagliptin (31 vs. 18% respectively; p <0.001). The addition of hydroxychloroquine significantly (p<0.001) reduced fasting plasma glucose by 31.0mg/dl (vs 23.2mg/dl with sitagliptin) and post prandial plasma glucose by 52.1mg/dl (vs 41mg/dl with sitagliptin) relative to sitagliptin. The difference in mean value of total daily insulin dose showed a highly significant decrease (P <0.0001) from baseline to end of the treatment with hydroxychloroquine i.e. from 41±10.2 to 31.87±16.49 IU as compare to sitagliptin i.e. from 41±10.6 to 37.91±11.71 IU. And also highly significant (P <0.0001) decrease in mean weight was observed at the end of trial with hydroxychloroquine.Conclusions: Hydroxychloroquine decreases HbA1c in patients whose type 2 diabetes is poorly controlled with stable-dose insulin therapy with metformin and glimepiride.