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1.
Article in English | MEDLINE | ID: mdl-37212480

ABSTRACT

Summary: A patient treated with intramuscular testosterone replacement therapy for primary hypogonadism developed blurred vision shortly after receiving his testosterone injection. The symptom resolved over subsequent weeks and recurred after his next injection. A diagnosis of central serous chorioretinopathy (CSR) was confirmed following ophthalmology review. A decision was made to change the patient's testosterone regime from this 12-weekly intramuscular injection to a daily topical testosterone gel, given the possibility that peak blood levels of testosterone following intramuscular injection were causing his ocular complaint. His CSR did not recur after this change in treatment. CSR secondary to testosterone therapy is a rare finding but has been reported previously in the literature. Learning Points: Blurred vision in patients treated with testosterone replacement therapy (TRT) should prompt an ophthalmology review. The potential for reduced risk of central serous chorioretinopathy (CSR) with daily transdermal testosterone remains a matter of conjecture. CSR is a rare potential side effect of TRT.

2.
Article in English | MEDLINE | ID: mdl-32101524

ABSTRACT

SUMMARY: We present three cases of acute diabetic neuropathy and highlight a potentially underappreciated link between tightening of glycaemic control and acute neuropathies in patients with diabetes. Case 1: A 56-year-old male with poorly controlled type 2 diabetes (T2DM) was commenced on basal-bolus insulin. He presented 6 weeks later with a diffuse painful sensory neuropathy and postural hypotension. He was diagnosed with treatment-induced neuropathy (TIN, insulin neuritis) and obtained symptomatic relief from pregabalin. Case 2: A 67-year-old male with T2DM and chronic hyperglycaemia presented with left lower limb pain, weakness and weight loss shortly after achieving target glycaemia with oral anti-hyperglycaemics. Neurological examination and neuro-electrophysiological studies suggested diabetic lumbosacral radiculo-plexus neuropathy (DLPRN, diabetic amyotrophy). Pain and weakness resolved over time. Case 3: A 58-year-old male was admitted with blurred vision diplopia and complete ptosis of the right eye, with intact pupillary reflexes, shortly after intensification of glucose-lowering treatment with an SGLT2 inhibitor as adjunct to metformin. He was diagnosed with a pupil-sparing third nerve palsy secondary to diabetic mononeuritis which improved over time. While all three acute neuropathies have been previously well described, all are rare and require a high index of clinical suspicion as they are essentially a diagnosis of exclusion. Interestingly, all three of our cases are linked by the development of acute neuropathy following a significant improvement in glycaemic control. This phenomenon is well described in TIN, but not previously highlighted in other acute neuropathies. LEARNING POINTS: A link between acute tightening of glycaemic control and acute neuropathies has not been well described in literature. Clinicians caring for patients with diabetes who develop otherwise unexplained neurologic symptoms following a tightening of glycaemic control should consider the possibility of an acute diabetic neuropathy. Early recognition of these neuropathies can obviate the need for detailed and expensive investigations and allow for early institution of appropriate pain-relieving medications.

5.
Diabetes Obes Metab ; 17(2): 202-6, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25387855

ABSTRACT

The aim of the present study was to compare the long-term safety and efficacy of insulin degludec with those of insulin glargine in patients with advanced type 2 diabetes (T2D) over 78 weeks (the 52-week main trial and a 26-week extension). Patients were randomized to once-daily insulin degludec or insulin glargine, with mealtime insulin aspart ± metformin ± pioglitazone, and titrated to pre-breakfast plasma glucose values of 3.9-4.9 mmol/l (70-88 mg/dl). After 78 weeks, the overall rate of hypoglycaemia was 24% lower (p = 0.011) and the rate of nocturnal hypoglycaemia was 31% lower (p = 0.016) with insulin degludec in the extension trial set, while both groups of patients achieved similar glycaemic control. Rates of adverse events and total insulin doses were similar for both groups in the safety analysis set. During 18 months of treatment, insulin degludec + mealtime insulin aspart ± oral antidiabetic drugs in patients with T2D improves glycaemic control similarly, but confers lower risks of overall and nocturnal hypoglycaemia than with insulin glargine treatment.


Subject(s)
Blood Glucose/drug effects , Diabetes Mellitus, Type 2/drug therapy , Glycated Hemoglobin/drug effects , Hypoglycemia/prevention & control , Hypoglycemic Agents/administration & dosage , Insulin, Long-Acting/administration & dosage , Diabetes Mellitus, Type 2/blood , Drug Administration Schedule , Drug Therapy, Combination , Humans , Hypoglycemia/chemically induced , Hypoglycemic Agents/adverse effects , Insulin, Long-Acting/adverse effects , Treatment Outcome
6.
QJM ; 106(7): 635-8, 2013 Jul.
Article in English | MEDLINE | ID: mdl-23525164

ABSTRACT

BACKGROUND: Although regular exercise is a critical component of the management of type 2 diabetes, many patients do not meet their exercise targets. Lack of exercise is associated with obesity and adverse cardiovascular outcomes. AIM: We aimed to assess exercise habits in obese Irish patients with type 2 diabetes to determine if patients are adhering to exercise guidelines and to identify perceived barriers to exercise in this group. DESIGN: A cross-sectional study of obese patients with type 2 diabetes attending routine outpatient diabetes clinics at our institution, a public teaching hospital located on the outskirts of Dublin City. METHODS: A total of 145 obese patients with type 2 diabetes were administered a questionnaire to evaluate exercise habits and perceived barriers to exercise. Anthropometric details were measured. RESULTS: About 47.6% (n = 69) of patients exercised for <150 minutes per week (40% of males, 62% of females; P = 0.019) and these patients had a higher body mass index than those meeting targets (35 vs. 33.5 kg/m(2); P = 0.02). Perceived barriers to exercise were varied, with lack of time and physical discomfort being the most common. Reported barriers to exercise varied with age, gender and marital status. CONCLUSION: This study highlights the challenges facing clinicians in improving exercise levels in patients, and the need to identify the specific barriers to exercise in the individual to improve health outcomes.


Subject(s)
Diabetes Mellitus, Type 2/psychology , Exercise/psychology , Obesity/psychology , Age Factors , Cross-Sectional Studies , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/therapy , Female , Humans , Ireland/epidemiology , Male , Marital Status , Middle Aged , Obesity/complications , Obesity/therapy , Sedentary Behavior , Sex Factors , Time Factors
7.
Article in English | MEDLINE | ID: mdl-24616778

ABSTRACT

UNLABELLED: Silent myocardial ischaemia (SMI), defined as objective evidence of myocardial ischaemia in the absence of symptoms, has important clinical implications for the patient with coronary artery disease. We present a dramatic case of SMI in a diabetes patient who attended annual review clinic with ST elevation myocardial infarction. His troponin was normal on admission but raised to 10.7 ng/ml (normal <0.5) when repeated the next day. His angiogram showed diffused coronary artery disease. We here discuss the implications of silent ischaemia for the patient and for the physician caring for patients with diabetes. LEARNING POINTS: Silent myocardial ischaemia (SMI) is an important clinical entity.SMI is common and occurs with increased frequency in patients with diabetes.SMI is an independent predictor of mortality.Recognition may lead to early intervention.

8.
Ir J Med Sci ; 180(1): 211-4, 2011 Mar.
Article in English | MEDLINE | ID: mdl-20721695

ABSTRACT

BACKGROUND: In recent years, rising numbers of medical students and an increasingly demanding clinical workload has put pressures on the educational systems for medical students in the hospital. Bedside teaching remains central to education, but tutorial delivery by registrars, tutors and consultants has proven to be increasingly difficult with the greater numbers of students now in the undergraduate system. AIMS: We have performed a pilot study to determine the feasibility of developing a Junior Tutor Programme, to assist in the delivery of tutorials to undergraduate medical students. METHODS: This was designed and delivered by interns under the supervision of the academic staff in the Departments of Medicine and Surgery in Connolly Hospital. The programme was evaluated by a questionnaire filled in by the students anonymously. RESULTS: A supervised programme of tutorials delivered by interns is a potentially useful way to ensure delivery of clinical teaching to undergraduate medical students.


Subject(s)
Education, Medical, Undergraduate , Faculty, Medical , Internship and Residency , Adult , Feasibility Studies , Humans , Pilot Projects , Teaching , Workforce
9.
Ir J Med Sci ; 179(2): 269-72, 2010 Jun.
Article in English | MEDLINE | ID: mdl-20119856

ABSTRACT

BACKGROUND: Calpain 10 (CAPN10) gene may contribute to the pathogenesis of type 2 diabetes mellitus (T2DM). AIM: To examine the contribution of four CAPN10 gene variants to T2DM risk in an Irish sample. METHODS: Genotyping of marker 19 insertion-deletion (ins/del) and three CAPN10 variants, rs3792267, rs3749166 and rs5030952 at the CAPN10 gene was performed in 236 T2DM subjects and 120 controls. Allelic, genotypic and haplotype comparisons were conducted between the groups. RESULTS: In the examined markers, no significant differences were observed although the deletion/deletion allele tended to be more common in T2DM subjects (chi(2) = 3.2, P = 0.07). A significant overrepresentation of a haplotype comprising (rs3792267), (19) and rs3749166 (chi(2) = 5.3, P = 0.021) was seen in T2DM subjects. Two protective haplotypes were detected: (G-ins-G) of (rs3792267), (19) and rs3749166 (chi(2) = 6.7, P = 0.009) and (ins-G-C) of (19), (rs3749166) and rs5030952 (chi(2) = 8.5, P = 0.003). CONCLUSIONS: CAPN10 gene variants may affect T2DM susceptibility in the Irish population.


Subject(s)
Calpain/genetics , Diabetes Mellitus, Type 2/genetics , Haplotypes/genetics , Alleles , Case-Control Studies , Diabetes Mellitus, Type 2/epidemiology , Diabetes Mellitus, Type 2/physiopathology , Female , Gene Deletion , Gene Frequency , Genetic Markers , Genetic Variation , Genotype , Humans , Ireland/epidemiology , Linkage Disequilibrium , Male , Middle Aged , Odds Ratio , Polymorphism, Genetic
10.
Ir J Med Sci ; 179(2): 179-82, 2010 Jun.
Article in English | MEDLINE | ID: mdl-19813048

ABSTRACT

BACKGROUND: The use of the bedside to teach the art of clinical medicine is controversial. Rising student numbers can limit patient availability. Studies examining inpatient attitudes to bedside teaching are few. AIMS: We examined inpatients' attitudes to bedside teaching of undergraduate medical students. METHODS: The study was carried out in a 439-bed teaching hospital. A questionnaire, numerically scored (0-10), was prospectively administered to 102 consecutive patients involved in bedside teaching of undergraduate medical students. RESULTS: The results were available from 92 patients. Patients enjoyed the teaching process (mean score 9.13 +/- 1.16) and benefited from a better understanding of their illness (7.11 +/- 2.57). Patients appreciated their role in educating future doctors (mean score 9.52 +/- 1.11) but demonstrated less confidence in their personal contribution to the teaching process (7.81 +/- 1.89). CONCLUSIONS: Inpatients are very willing participants in bedside teaching of undergraduate medical students.


Subject(s)
Education, Medical, Undergraduate/methods , Patient Satisfaction/statistics & numerical data , Point-of-Care Systems , Practice Patterns, Physicians' , Teaching , Clinical Competence , Educational Measurement , Educational Status , Faculty, Medical , Female , Health Knowledge, Attitudes, Practice , Hospitals, Teaching , Humans , Inpatients , Ireland , Male , Middle Aged , Patient Acceptance of Health Care/statistics & numerical data , Students, Medical , Surveys and Questionnaires
11.
Diabetes Res Clin Pract ; 86(3): 208-12, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19783061

ABSTRACT

AIMS: Executive function (EF) comprises a set of cognitive skills that controls the execution of complex activities. In the context of diabetes, this may include patients' self-monitoring and daily management of their condition. We compared two different measures of EF in a population of elderly patients with type 2 diabetes mellitus (T2DM) and studied its relationship with diabetes self-care. METHODS: Fifty patients (34 males) had EF assessed using Frontal Assessment Battery (FAB) and Executive Interview 25 (EXIT25). Diabetes self-care was assessed using the Summary of Diabetes Self-Care Activities (SDSCA) scale. Haemoglobin A1c (HbA1c), lipid levels, blood pressure and diabetes duration were recorded. RESULTS: The mean age of the patients was 67.0+/-7.5 years and mean duration of diabetes was 8.1+/-6.4 years. Mean HbA1c was 7.0+/-1.2%, and mean fasting plasma glucose, cholesterol and LDL-C were 7.0+/-1.7mM, 4.0+/-0.9mM and 2.1+/-0.7mM respectively. Mean EXIT25 score was 9.5+/-4.6 in the range of normal EF (14% had EXIT25 score>15, indicating impaired EF). Mean FAB score was 13.7+/-3.3 (48% having scores<15, indicating impaired EF), suggesting a degree of dysexecutive syndrome involving frontal lobe functions. EXIT25 score was inversely correlated with SDSCA (r=-0.3, p<0.05) but no significant correlation between FAB and SDSCA or HbA1c, diabetes duration, lipid levels and blood pressure with EXIT25, FAB or SDCSA was found. CONCLUSION: A substantial proportion of elderly patients with T2DM may have dysexecutive syndrome and impairment in EF may impact on self-care in this group.


Subject(s)
Cognition , Diabetes Mellitus, Type 2/psychology , Executive Function/physiology , Geriatric Assessment/methods , Self Care , Age of Onset , Aged , Blood Glucose/analysis , Blood Pressure , Body Mass Index , Cognition Disorders/epidemiology , Cognition Disorders/psychology , Diabetes Mellitus, Type 2/blood , Glycated Hemoglobin/analysis , Humans , Interviews as Topic , Lipids/blood , MMPI , Middle Aged
13.
Horm Metab Res ; 41(12): 905-9, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19705345

ABSTRACT

This report is part of the overall evaluation of using vildagliptin in the treatment of type 2 diabetes. Here the results of a multi-center, double-blind, randomized, active-controlled study designed to compare the efficacy and safety of two years of monotherapy with vildagliptin 50 mg bid and gliclazide up to 320 mg/day in drug-naïve patients with type 2 diabetes are reported. A total of 546 patients were randomized and approximately 74% of patients completed the study in each group. HbA (1c) values were slightly higher in the gliclazide group (HbA (1c) of 8.7+/-0.1% vs. 8.5+/-0.1% in the vildagliptin group). The mean reduction in HbA (1c) from baseline to Week 104 was -0.5% in the vildagliptin group and -0.6% in the gliclazide group. The associated 95% confidence interval (CI) for the between-group difference (0.13%) in mean change was (-0.06%, 0.33%). Thus, noninferiority based on an upper limit of the CI of 0.3% was not met. In the vildagliptin group, weight increased by 0.8+/-0.2 kg compared to 1.6+/-0.2 kg in the gliclazide group (p<0.01). Mild hypoglycemia was recorded in 0.7% of patients in the vildagliptin group and in 1.7% in the gliclazide group. Both drugs were well tolerated. In summary, vildagliptin monotherapy resulted in improved glycemic control in drug-naïve patients with type 2 diabetes. Although the hypothesis of noninferiority to gliclazide was not borne out statistically, the reductions in HbA (1c) were similar over a two year period and vildagliptin had significant benefits in terms of less weight gain and less hypoglycemia.


Subject(s)
Adamantane/analogs & derivatives , Diabetes Mellitus, Type 2/drug therapy , Dipeptidyl-Peptidase IV Inhibitors/adverse effects , Dipeptidyl-Peptidase IV Inhibitors/therapeutic use , Gliclazide/adverse effects , Gliclazide/therapeutic use , Nitriles/adverse effects , Nitriles/therapeutic use , Pyrrolidines/adverse effects , Pyrrolidines/therapeutic use , Adamantane/adverse effects , Adamantane/therapeutic use , Demography , Female , Glycated Hemoglobin/metabolism , Humans , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/therapeutic use , Male , Middle Aged , Time Factors , Treatment Outcome , Vildagliptin
14.
Ir J Med Sci ; 178(3): 309-13, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19495843

ABSTRACT

BACKGROUND: Metabolic syndrome (MetS) is a vascular risk factor with prevalence in the general population of 17-25%. AIM: To determine the prevalence of MetS in patients with diabetes mellitus (DM). METHODS: A total of 200 patients [18% type 1 (T1DM), 82% type 2 (T2DM)] attending for annual review were studied. Standard blood tests were requested. Blood pressure and waist circumference were measured. Adult Treatment Panel III (ATP III) criteria for diagnosis of MetS were applied. RESULTS: A total of 122 (61%) patients had MetS. More patients with T2DM (69.5%) than TIDM (22.2%) had MetS. Despite treatment of DM (100%), hypertension (69.5%) and dyslipidaemia (48.3%), 114 patients (57%) still met the criteria for MetS at time of study. CONCLUSIONS: Most T2DM patients have MetS but it is uncommon in T1DM. Despite treatment, almost half of patients still met the criteria for MetS. Aggressive treatment of MetS components is required to reduce cardiovascular risk in DM.


Subject(s)
Diabetes Mellitus , Metabolic Syndrome/epidemiology , Adult , Blood Glucose , Case-Control Studies , Female , Humans , Ireland/epidemiology , Male , Metabolic Syndrome/diagnosis , Middle Aged , Prevalence , Risk Assessment , Risk Factors
15.
Ir J Med Sci ; 178(4): 401-6, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19259760

ABSTRACT

BACKGROUND: Patients' awareness of the increased cardiovascular risk associated with their diabetes is poorly documented. AIM: The aim of this study was to assess the awareness of diabetes complications among patients with diabetes in Ireland. METHODS: Patients attending diabetes outpatient clinics in two teaching hospitals in different regions of the country were invited to complete a questionnaire. RESULTS: A total of 258 (59.3% male) patients completed the questionnaire; mean age 57.8 years. On questioning, 53.5% reported cardiovascular disease as a potential complication of diabetes, with awareness rates of 61.2, 17.1, 16.3 and 12% for retinopathy, stroke, peripheral vascular disease and amputation, respectively. Disappointingly, less than half of respondents felt that improvements in diet and exercise could potentially reduce their cardiovascular risk. CONCLUSIONS: Awareness of cardiovascular risk and knowledge of effective measures to reduce this were low in our study and an alternative means of education may need to be considered.


Subject(s)
Cardiovascular Diseases/epidemiology , Diabetic Cardiomyopathies/epidemiology , Health Knowledge, Attitudes, Practice , Cardiovascular Diseases/prevention & control , Diabetic Cardiomyopathies/prevention & control , Female , Health Behavior , Humans , Ireland , Male , Middle Aged , Risk Factors , Surveys and Questionnaires
16.
Curr Med Res Opin ; 25(4): 1029-35, 2009 Apr.
Article in English | MEDLINE | ID: mdl-19281426

ABSTRACT

OBJECTIVE: PREDICTIVE is a large, observational study of the empirical use of insulin detemir in patients with type 1 or type 2 diabetes (T1DM/T2DM). This post hoc analysis evaluates insulin-naïve patients with T2DM uncontrolled on oral antidiabetic drugs (OADs) who were initiated and remained on once-daily insulin detemir for 12 weeks. RESEARCH DESIGN AND METHODS: This observational, multinational, multi-center, open-label prospective study evaluated the efficacy and safety of insulin detemir in 1653 insulin-naïve patients with T2DM (mean age 60.8 +/- 10.9 years, BMI 29.8 +/- 4.8 kg/m(2), and HbA(1C) 8.82 +/- 1.50%). Statistical comparisons were made between baseline and 12-week follow up data. Our study was subject to the usual limitations of observational studies. MAIN OUTCOME MEASURES: Endpoints were: incidence of serious adverse drug reactions, including number of hypoglycemic events (total, major, and nocturnal), glycemic parameters, and weight change. RESULTS: Following insulin initiation, no significant change occurred in the number of nocturnal hypoglycemic events or total hypoglycemic events (p = 0.4513), and no serious adverse drug reactions were observed during the 12 weeks of treatment. HbA(1C) decreased by a mean 1.25% (SD +/- 1.25%; p < 0.0001), with 30% of patients (n = 383) achieving HbA(1C) <7% at 12 weeks. Mean changes in fasting blood glucose and fasting blood glucose variability were -3.62 mmol/L (SD +/- 2.93; p < 0.0001) and -0.48 mmol/L (SD +/- 1.03; p < 0.0001), respectively. Body weight decreased by a mean 0.5 kg (SD +/- 3.3; p < 0.0001), with weight loss or no weight change occurring in a substantial percentage of patients in each BMI category (<25, 25-30, 30-35, and >35 kg/m(2)). Patients with higher baseline BMI lost the most weight, with the greatest weight loss (-1.20 kg) reported in those with BMI >35 kg/m(2). CONCLUSIONS: Empirical use of insulin detemir as an insulin initiation strategy can improve glycemic control with good tolerability, including a low risk of hypoglycemia and a weight benefit, in a majority of insulin-naïve patients uncontrolled on OADs.


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin/analogs & derivatives , Aged , Blood Glucose/drug effects , Blood Glucose/metabolism , Body Mass Index , Body Weight/drug effects , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 2/blood , Drug Administration Schedule , Glycated Hemoglobin/metabolism , Humans , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Hypoglycemic Agents/adverse effects , Insulin/adverse effects , Insulin/therapeutic use , Insulin Detemir , Insulin, Long-Acting , Middle Aged , Safety
17.
Ir J Med Sci ; 177(3): 269-72, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18516660

ABSTRACT

OBJECTIVE: We describe a case of Cushing's syndrome due to ectopic ACTH secretion, where the only potential source on conventional imaging was a tiny benign-appearing lung nodule, which failed to take up radiolabelled octreotide. DESIGN AND METHODS: To determine whether the patient might respond to therapeutic administration of octreotide, a test dose was given. RESULTS: Compared to ACTH and cortisol levels on a control day, the levels following the test dose of octreotide were lower. Subsequent therapeutic administration of subcutaneous octreotide normalised urine free cortisol, with symptomatic improvement, pending evaluation for surgery. Eventual resection of the lung nodule resulted in cure of hypercortisolism. Histological examination of the resected specimen confirmed bronchial carcinoid staining positive for ACTH. CONCLUSIONS: This is one of the few cases described where ectopic ACTH secretion secondary to bronchial carcinoid responded to somatostatin analogue therapy. The case was also unusual in that the tumour responded despite not taking up radiolabelled octreotide.


Subject(s)
ACTH Syndrome, Ectopic/etiology , Bronchial Neoplasms/diagnosis , Carcinoid Tumor/diagnosis , Pituitary ACTH Hypersecretion/etiology , Adult , Bronchial Neoplasms/complications , Bronchial Neoplasms/metabolism , Bronchial Neoplasms/surgery , Carcinoid Tumor/complications , Carcinoid Tumor/metabolism , Carcinoid Tumor/surgery , Diagnosis, Differential , Humans , Male , Tomography, X-Ray Computed
18.
Int J Clin Pract ; 62(4): 659-65, 2008 Apr.
Article in English | MEDLINE | ID: mdl-18324957

ABSTRACT

OBJECTIVE: Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation (PREDICTIVE) is a multi-national, open-label, prospective, observational study assessing the safety and efficacy of insulin detemir in clinical practice. This post hoc subanalysis evaluates insulin-naïve patients on oral antidiabetic drugs (OADs) who were initiated on insulin detemir as basal therapy (+/- OADs). METHODS: The European cohort of the PREDICTIVE study currently includes 20,531 patients (12,981 with type 2 diabetes) who were prescribed insulin detemir and followed up for 12, 26 or 52 weeks. Here, we report data from a subgroup of 2377 OAD-treated, insulin-naïve type 2 diabetes patients for a mean follow-up of 14.4 weeks. Patients were prescribed insulin detemir as basal therapy (+/- OADs) by their physician, as part of routine clinical care. Results were reported in comparison with baseline observations. RESULTS: One serious adverse drug reaction was reported, which was a major hypoglycaemic episode. Treatment with insulin detemir (+/- OADs) significantly reduced mean haemoglobin A(1c) (HbA(1c)) (-1.3%; p < 0.0001), fasting glucose (-3.7 mmol/l; p < 0.0001), and within-patient fasting glucose variability (-0.5 mmol/l; p < 0.0001). In the majority of patients (82%), these improvements in glycaemic control were achieved with once daily administration of insulin detemir. There was a small reduction in mean body weight (-0.7 kg; p < 0.0001), which was most apparent in patients with a higher body mass index (BMI) at baseline. A significant negative relationship between weight change and baseline BMI was observed (greater the BMI, greater the weight reduction). Multiple regression analysis showed that BMI and HbA(1c) at baseline, and change in HbA(1c), were all predictors for weight change (p < 0.0001 for all), with BMI being the strongest predictor. CONCLUSIONS: Patients with type 2 diabetes naïve to insulin can be effectively treated with once-daily insulin detemir (+/- OADs) to achieve improved glycaemic control with no adverse effect on weight and a low risk of hypoglycaemia. These short-term results are consistent with the findings of clinical trials.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin/analogs & derivatives , Cohort Studies , Female , Humans , Insulin/therapeutic use , Insulin Detemir , Insulin, Long-Acting , Male , Middle Aged , Prospective Studies
19.
Int J Clin Pract ; 62(12): 1971-80, 2008 Dec.
Article in English | MEDLINE | ID: mdl-19166444

ABSTRACT

BACKGROUND: The PREDICTIVE study is a multinational observational study designed to follow up patients with diabetes who started insulin detemir (IDet) in routine care. Recruitment started in June 2004 and is ongoing in some countries. METHODS: We report 12-week follow-up data for patients with type 1 (T1D) or type 2 diabetes (T2D) in the European cohort who, as part of basal-bolus therapy, switched from once- (qd) or twice-daily (bid) neutral protamine Hagedorn insulin (NPH) to qd IDet. End-points - evaluated from patients' records and diaries - were incidence of serious adverse drug reactions, glycaemic parameters, hypoglycaemia and weight change. RESULTS: A total of 3637 patients were included, n = 1500 T1D [mean age 40.9 years, body mass index (BMI) 25.0 kg/m(2), glycosylated haemoglobin (HbA(1c)) 7.9%] and n = 2137 T2D (mean age 60.5 years, BMI 31.9 kg/m(2), HbA(1c) 8.0%). IDet was well tolerated. Lower overall, major and nocturnal rates of hypoglycaemia were observed in T1D and T2D patients switching from NPH to IDet (overall, T1D: 38.2-18.56 episodes/patient year, p < 0.001; T2D: 13.8-3.3 [corrected] episodes/patient year, p < 0.001). Switching from bid NPH to qd IDet resulted in significant 12-week reductions in HbA(1c) (T1D: -0.40%; T2D: -0.56%; both p < 0.001). Switching from qd NPH to qd IDet, resulted in HbA(1c) reductions of: T1D -0.52%; T2D -0.56%; both p < 0.001. Fasting blood glucose levels were also significantly reduced in patients with T1D or T2D. Overall mean weight changes were: T1D: 0.0 kg, T2D: -0.2 kg after 12 weeks. CONCLUSION: In routine care, patients with T1D or T2D may be switched from NPH to IDet qd as part of a basal-bolus regimen.


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin, Isophane/therapeutic use , Insulin/analogs & derivatives , Adult , Blood Glucose/metabolism , Diabetes Mellitus, Type 1/metabolism , Diabetes Mellitus, Type 2/metabolism , Fasting , Female , Glycated Hemoglobin/metabolism , Humans , Hypoglycemia/etiology , Insulin/administration & dosage , Insulin Detemir , Insulin, Long-Acting , Male , Middle Aged , Prospective Studies
20.
Diabetes Obes Metab ; 10(1): 75-81, 2008 Jan.
Article in English | MEDLINE | ID: mdl-18034846

ABSTRACT

AIM: The aim of this study was to evaluate the safety and efficacy of insulin detemir in type 2 diabetes patients previously receiving NPH insulin (NPH group, n = 175) or insulin glargine (glargine group, n = 118) in combination with oral antidiabetic drugs (OADs). METHODS: Patients were transferred to insulin detemir, while the OAD regimen and number of injections remained the same. The incidence of serious adverse drug reactions, including major hypoglycaemia, and haemoglobin A(1c) (HbA(1c)), fasting glucose, within-patient fasting glucose variability and body weight change were measured at 14 weeks. RESULTS: Glycaemic control improved in both NPH (HbA(1c) = -0.2%, p < 0.05; fasting glucose -1.0 mmol/l, p < 0.0001) and glargine (HbA(1c) = -0.6%, p < 0.0001; fasting glucose -1.4 mmol/l, p < 0.0001) groups, including a reduction in fasting glucose variability (p < 0.01 for both). The incidence of total and nocturnal hypoglycaemia was reduced in both NPH and glargine groups. The incidence of major hypoglycaemia was low and did not change significantly during the follow-up period. Mean body weight was significantly reduced in the NPH (-0.7 kg, p < 0.01) and glargine (-0.5 kg, p < 0.05) groups. CONCLUSIONS: These results indicate that in type 2 diabetes, transferring from other basal insulins to insulin detemir in combination with OADs was associated with improvements in glycaemic control, which were accompanied by a reduced risk of hypoglycaemia and a reduction in body weight.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin/analogs & derivatives , Administration, Oral , Blood Glucose/analysis , Blood Glucose/drug effects , Diabetes Mellitus, Type 2/metabolism , Drug Administration Schedule , Female , Glycated Hemoglobin/analysis , Humans , Hypoglycemia/prevention & control , Insulin/metabolism , Insulin/therapeutic use , Insulin Detemir , Insulin Glargine , Insulin, Long-Acting , Male , Middle Aged , Treatment Outcome , Weight Gain
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