Efficacy and Renal Safety of Dapagliflozin in Patients with Type 2 Diabetes Mellitus Also Receiving Metformin: A Real-Life Experience.

INTRODUCTION: This study aimed at evaluating the efficacy and safety of dapagliflozin in patients with type 2 diabetes (T2D) who also received metformin in clinical practice in Italy. METHODS: This was a retrospective observational study and it included data from patients who received dapagliflozin 10 mg once daily in conjunction with metformin for 12 months (DAPA + MET). In those with inadequate glycemic control, insulin or glimepiride was added after 30 days (DAPA + MET + other glucose-lowering drugs). Efficacy assessments included glycosylated hemoglobin (HbA1c) levels at 6 and 12 months, as well as body mass index (BMI) and lipid parameters at 12 months. Safety was also assessed. RESULTS: Data on 66 patients were included. In both groups, HbA1c was significantly reduced at 6 and 12 months compared with baseline and significant reductions in HbA1c were observed at 12 months compared with 6 months. Over the 12-month treatment period, dapagliflozin significantly reduced BMI in both groups. No significant changes in lipid parameters were observed in either group and no detrimental effects on renal function were detected. CONCLUSIONS: Dapagliflozin is effective and safe in patients with T2D also receiving metformin. Glycemic control was already achieved with dapagliflozin + metformin, and add-on therapy was not associated with further improvements.

The effectiveness and durability of an early insulin pump therapy in children and adolescents with type 1 diabetes mellitus.

BACKGROUND: This study evaluated the predictors of effectiveness and durability of insulin pump therapy in children and adolescents who have initiated continuous subcutaneous insulin infusion (CSII) within 2 years after the diagnosis of type 1 diabetes mellitus (T1DM). SUBJECTS AND METHODS: The charts of individuals with T1DM using insulin pumps who were treated at our center were reviewed, including subjects with age at onset of <22 years, interval between onset and insulin pump commencement (interval onset-commencement) of <2 years, use of pumps of >1 year, and use of glucose sensors for <4 weeks/year. The primary end point was the mean glycosylated hemoglobin (HbA1c) value (MHbA1c) throughout the follow-up. RESULTS: From 684 patients treated with insulin pumps, 119 met the inclusion criteria, and 113 were selected for statistical analysis (60 females; age at diabetes onset, 8.9±5.6 years [mean±SD]; follow-up, 4.0±1.8 years; range, 1-8 years; baseline HbA1c, 9.3±1.8%). Only the interval onset-commencement was a linear predictor of the MHbA1c (P=0.01; R(2)=0.089). A significant reduction of the mean yearly HbA1c from baseline throughout all the follow-up was observed (P<0.001). Categorizing the sample into four quartiles on the basis of an increasing interval onset-commencement resulted in levels of MHbA1c significantly lower in the first and second quartiles in comparison with the fourth quartile (7.6±0.8% and 7.8±1.0%, respectively, versus 8.5±0.8%; P<0.001 and P=0.004, respectively). CONCLUSIONS: The present study suggests that early pump commencement in children and adolescents with T1DM provides lower and more durable HbA1c values than a late commencement. It is possible that an early pump commencement could prolong the honeymoon phase, but we cannot confirm or exclude this hypothesis because the lack of data about C-peptide levels during the follow-up.

Comparison of TSH Levels with Liquid Formulation Versus Tablet Formulations of Levothyroxine in the Treatment of Adult Hypothyroidism.

OBJECTIVE: A great number of factors can interfere with levothyroxine (LT4) tablet absorption, leading to increased serum thyroid-stimulating hormone (TSH) levels and, accordingly, to increased LT4 requirements. LT4 oral solution (LT4-OS) is a novel formulation with a pharmacokinetics profile different from those of tablets. The aim of this study was to retrospectively evaluate whether serum TSH levels were decreased after switching adult hypothyroid patients from the tablet to LT-OS. METHODS: We retrospectively evaluated 53 outpatients on LT4 replacement therapy (consumed within 1 hour before breakfast) who switched from LT4 tablets to LT4-OS without changing the daily dose. We compared preswitch TSH (TSH1) with TSH level 60 to 90 days after the switch (TSH2) and examined the clinical differences between the patients whose TSH did and did not drop after the switch. RESULTS: After the switch, TSH levels decreased from a median value of 3.04 (interquartile range [IQR] 1.75-6.80) to 2.30 (IQR 1.21-3.81) µIU/mL, and the difference was significant (P = .0034). We observed a TSH reduction (TSH2/TSH1 ratio <1) in 36/53 (67.9%) of patients; the median TSH2/TSH1 ratio was 0.71 (IQR 0.37-1.14). In the group of patients whose TSH dropped, we observed an increased frequency of factors interfering with LT4 absorption (P = .014). The median TSH2/TSH1 ratios were 0.50 (IQR 0.31-0.72) and 0.85 (IQR 0.65-1.36) for patients with and without interfering factors, respectively. CONCLUSION: Our study confirms that LT4-OS could have an increased absorption rate in comparison to LT4 tablets, especially in the presence of other factors interfering with LT4 absorption.

Prognostic accuracy of continuous glucose monitoring in the prediction of diabetes mellitus in children with incidental hyperglycemia: receiver operating characteristic analysis.

AIM: The purpose of this study is to evaluate continuous glucose monitoring (CGM) in predicting diabetes mellitus in children with incident hyperglycemia (IH) and negativity for some insular autoantibodies. SUBJECTS AND METHODS: Thirty-one autoantibody-negative children who presented at our center with IH underwent a baseline assessment and were followed up for 23.8 months (range, 6-48 months). At the end of the follow-up, we compared the receiver operating characteristic (ROC) areas under the curve (AUCs) of metabolic markers from 17 children who developed diabetes (Group A; n=17) and 14 children who did not develop diabetes (Group B; n=14). RESULTS: Only two oral glucose tolerance test (OGTT)-derived markers and three CGM-derived markers showed a good prognostic performance, with ROC AUCs indicating significant results (P<0.0001) for the following markers: 2-h glucose, OGTT (0.813; 95% confidence interval [CI] 0.621-0.954); AUC glucose, OGTT (0.832; 95% CI 0.611-0.950); CGM glucose measurement peak (0.803; 95% CI 0.621-0.923); percentage of CGM glucose measurements inside the range 70-125 mg/dL (0.866; 95% CI 0.695-0.961); and percentage of CGM measurements ≥126 mg/dL (0.889; 95% CI 0.724-0.973). The combination of the OGTT-derived markers did not increase the predictive value, but the combination of CGM markers with each other or with the OGTT markers yielded higher ROC AUCs (ranging from 0.828 to 0.945). CONCLUSIONS: This is the first study showing that CGM is useful in predicting diabetes mellitus in children with IH.