학술논문
A randomized, double-blind, active-controlled trial assessing the efficacy and safety of a fixed-dose combination (FDC) of MEtformin hydrochloride 1000 mg ER, SItagliptin phosphate 100 mg, and DApagliflozin propanediol 10 mg in Indian adults with type 2 diabetes: The MESIDA trial
Document Type
Article
Author
Singh, Awadhesh Kumar; Sahay, Rakesh; Gil, Navneet; Tripathi, Sudhir; Khandelwal, Vipul; Basu, Indraneel; Shembalkar, Jayashree; Srivastava, Manoj Kumar; Bhatia, Girish; Pathak, Vaishali; Dange, Amol; Chaudhri, Mayura; Naskar, Arindam; Mondal, Ashish; Gangwal, Pawan; Kumar, Surendra; Kumar, Deepak; Raju, Yandrapati gnana sundara; Sorate, Sanket; Gavli, Onkar
Source
Subject
*BLOOD sugar analysis
*METFORMIN
*COMBINATION drug therapy
*PATIENT safety
*CONTROLLED release preparations
*GLYCOSYLATED hemoglobin
*FOOD consumption
*RESEARCH funding
*SITAGLIPTIN
*DAPAGLIFLOZIN
*BLIND experiment
*STATISTICAL sampling
*BODY weight
*HYPOGLYCEMIC agents
*RANDOMIZED controlled trials
*DESCRIPTIVE statistics
*TYPE 2 diabetes
*DRUG efficacy
*RESEARCH
*DOSAGE forms of drugs
*COMPARATIVE studies
*GENETIC techniques
*FASTING
*EVALUATION
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Language
ISSN
0973-3930
Abstract
Objective: To assess the efficacy and safety of fixed-dose combinations (FDC) of triple-drug dapagliflozin, sitagliptin, and metformin (DSM) compared with FDC of two-drug sitagliptin and metformin (SM), in Indian adult patients with type 2 diabetes (T2D). Methods: A multicentric, randomized, double-blind, active-controlled, Phase 3 study (CTRI/2021/10/037461) was conducted on 274 Indian adult patients with T2D. Patients were randomized (1:1) to receive either an FDC of triple-drug (n = 137) dapagliflozin propanediol 10 mg, sitagliptin phosphate 100 mg, and metformin hydrochloride 1000 mg extended-release (DSM) or FDC of two-drug (n = 137) sitagliptin phosphate 100 mg and metformin hydrochloride 1000 mg sustained-release (SM), for 16 weeks. The primary endpoint was a change in HbA1c, while the secondary endpoints were changes in fasting plasma glucose (FPG), postprandial glucose (PPG), body weight, and safety. Results: Both DSM and SM FDCs reduced HbA1c significantly (-1.45% and -1.00%, respectively, both p < 0.0001), however, HbA1c lowering was superior with DSM (∆ -0.45%; p = 0.0005) compared to SM, at week 16. Similarly, both DSM and SM FDCs reduced FPG and PPG significantly, however, FPG (∆ -12.4 mg/dl; p = 0.003) and PPG reduction (∆ -18.45 mg/dl; p = 0.01) were significantly superior to DSM compared to SM, respectively. No significant reduction in body weight was observed between the two arms. Both FDCs were well tolerated. Conclusion: FDC of DSM was superior to SM in reducing HbA1c, FPG, and PPG in Indian adults with T2D. Both triple and dual FDCs had optimal safety profiles. [ABSTRACT FROM AUTHOR]