Efficacy and Safety of a Fixed-Dose Combination of Vildagliptin and Pioglitazone in Indian Patients With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Comparative, Phase III Study.

Background Type 2 diabetes mellitus (T2DM) arises due to a range of pathological abnormalities, necessitating a combination therapy to achieve optimal glycemic control. Vildagliptin, an effective and selective DPP-4 inhibitor, and pioglitazone, an insulin sensitizer, offer distinct mechanisms of action. Hence, the integration of these medications represents a logical and justified therapeutic strategy Objective To compare the efficacy, safety, and tolerability of vildagliptin and pioglitazone 50 mg/15 mg fixed-dose combination (FDC) tablets with individual monotherapy vildagliptin 50 mg and pioglitazone 15 mg tablets in Indian T2DM patients who were inadequately controlled on metformin monotherapy. Methods This was a randomized, open-label, comparative, multicenter, phase III study involving 195 T2DM patients with inadequate glycemic control on metformin ≥ 1000 mg/day. Patients were randomly assigned in a 1:1:1 ratio to the test product group (n=65) (vildagliptin 50 mg + pioglitazone 15 mg FDC tablets), reference product group 1 (n=65) (vildagliptin 50 mg tablet), or reference product group 2 (n=65) (pioglitazone 15 mg tablet reference product). The primary endpoint was the mean change in HbA1c levels from baseline to end of the study visit (12 weeks (84 days ±2)). The secondary endpoints were the mean change in fasting plasma glucose (FPG) and 2-hr postprandial plasma glucose (2-hr PPG) levels. Safety parameters were assessed till the end of the study. Results A total of 178 patients completed the study. At 12 weeks, the mean HbA1c level in the test group reduced to 6.85 ± 1.27%, in the reference product 1 group to 7.56 ± 1.72%, and in the reference product 2 groups to 7.37 ± 1.59%. The mean change in Hb1Ac from baseline in the test group was statistically significant compared to the reference groups (p=0.037). Similarly, the mean changes in the FPG and 2hr-PPG with the test product were statistically significant compared to reference products (p=0.041). The adverse events were comparable across all the treatment groups. Conclusion In Indian T2DM patients inadequately controlled on a daily maximum dose of metformin, treatment with vildagliptin and pioglitazone FDC showed better glycemic control than either vildagliptin or pioglitazone along with a good tolerability profile.

A prospective multicentre open label study to assess effect of Teneligliptin on glycemic control through parameters of time in range (TIR) Metric using continuous glucose monitoring (TOP-TIR study).

BACKGROUND AND AIMS: Continuous glucose monitoring (CGM) has been effective in assessing glycemic variability in diabetic patients. This study aims at assessing the effect of Teneligliptin using ambulatory glucose profile (AGP) indicators. METHODS: A prospective, multicentre, open label study enrolling 59 type 2 diabetes patients between 18 and 65 years age was done between November 2020-May 2021. Patients were administered Teneligliptin 20 mg once daily, in addition to Metformin. The study included pre-treatment and two post-treatment phases. The data on time in range (TIR) and other AGP indicators of glycemic variability were obtained on each patient in all the three study phases and analysed to understand the effect of Teneligliptin on glycemic variability. Safety evaluation was done based on vital and biochemical parameters. RESULTS: The percent TIR in post-treatment phase I was significantly higher than the pre-treatment phase (p < 0.0001), and was maintained till the end of phase II (p = 0.037). There was significant lowering of time above range (≥180 mg/dL) in the phase I (p = 0.003), which was maintained in phase II (p = 0.043), suggesting better control over hyperglycemic state. The reduction in mean glucose level in phase I and II was also significant compared to baseline (p = 0.003 and p = 0.023 respectively). The glucose variability percent and glucose management indicator also showed significant lowering in both the phases. CONCLUSIONS: Teneligliptin addition to patients uncontrolled on Metformin monotherapy significantly reduced glycemic variability, as well showed significant glycemic improvement. Since this study was a single arm study, a comparative study with other DPP-4 inhibitors is needed.

REAL-world evidence of risk factors and comorbidities in YOUNG Indian adults with type 2 diabetes mellitus: A REAL YOUNG (diabetes) study.

OBJECTIVE: To assess the clinical characteristics, risk factors, and comorbidities associated with type 2 diabetes mellitus (T2DM) in young adult patients. METHODS: This is a retrospective, multicentric real-world study that included young adults (18-45 years) with T2DM. Primary information including demographics, medical and family history, biochemical measures (pre-and post-prandial blood glucose levels, glycosylated hemoglobin [HbA1c] and blood pressure, and lipid parameters) smoking and drinking habits were collected retrospectively from the medical records of the respective hospitals/clinics. Data were analyzed using descriptive and appropriate comparative statistics. RESULTS: A total of 22,921 patients from 623 sites were included. The median age was 37.0 years and the majority were men (61.6%). The proportion of patients from the age group >35-≤45 years was 62.7%. Among all patients, 46.9% had only T2DM; however, 53.1% of patients had T2DM with other comorbidities (T2DM with hypertension, dyslipidemia, and both). The majority of patients had elevated body mass index (BMI) (overweight, 46.6%; and obese, 22.9%). Family history of T2DM (68.1%) was most common in overall population. Sedentary lifestyle (63.1%), alcohol consumption (38.9%), and regular smoking (23.1%) were the most common associations in patients with T2DM with dyslipidemia and hypertension. Uncontrolled HbA1c level (≥7%) were observed in 79.2% of patients. The level of HbA1c was significantly increased with the duration of T2DM and sedentary lifestyle (p < 0.001). CONCLUSION: Higher BMI, family history of T2DM, sedentary lifestyle, alcohol consumption, and smoking were the most common risk facors, while hypertension and dyslipidemia were the most prevalent comorbidities associated with T2DM in young Indian adults.

Best Practices and Tools for Titrating Basal Insulins: Expert Opinion from an Indian Panel via the Modified Delphi Consensus Method.

AIM: To develop an evidence-based expert group consensus document on the best practices and simple tools for titrating basal insulins in persons with type 2 diabetes mellitus (T2DM). BACKGROUND: Glycemic control is suboptimal in a large proportion of persons with T2DM, despite insulin therapy, thereby increasing the risk of potentially severe complications. Early initiation of insulin therapy and appropriate dose titration are crucial to achieving glycemic targets. Attitudes and practices among healthcare professionals (HCPs) and perceptions about insulin therapy among persons with diabetes contribute largely to suboptimal glycemic control. Improving HCP-patient communication, encouraging the use of additional educational tools, and providing support for the titration process to increase confidence, both at the initiation visit and at home, facilitate the optimization of dose titration. In Indian settings, specific guidelines and a consensus statement are lacking on the optimal insulin initiation dose, frequency of dose titration, and basal insulin profile needed to achieve optimal titration. In clinical practice, physicians and persons with diabetes often do not adhere to the titration algorithms that currently exist for the purpose of achieving optimal titration as they perceive these to be very cumbersome. In this context, a group of experts met at an advisory board meeting and arrived at a consensus on best practices for the titration of basal insulin in persons withT2DM in India, using the modified Delphi methodology. REVIEW RESULTS: After a review of evidence and further discussions, the expert group provided recommendations on insulin initiation dose, ideal period for titration in practice, titration regimen for use in practice, basal insulin profile for titration, and choosing a self-monitoring blood glucose schedule for titration. CONCLUSIONS: In the management of T2DM, insulin can be effectively titrated by following a few simple recommendations. The use of second-generation basal insulin aids in mitigating the risk of hypoglycemic events. The implementation of a simplified titration regimen is crucial to achieving glycemic targets and long-term treatment goals.