ECE2024 Poster Presentations Diabetes, Obesity, Metabolism and Nutrition (130 abstracts)
Subgroup analysis of phase 3 study of fixed-dose combination of dapagliflozin, glimepiride and metformin IR in type 2 diabetes mellitus patients with HbA1c 9%-11%
Prakash Kurmi 1 , Manish Singh 2 , Vishal Gupta 3 , Chikkalingaiah Siddegowda 4 , Jitendra Shukla 5 , Sandip Gofne 6 , Nilesh Lomte 7 , Kaustubh Shendkar 8 , Dinesh Gangwani 9 , Surendra Kumar 10 , Sandeep Gupta 11 , Aravind G Nagarajaiah 12 , Amit Bhaskar 13 , Prabhat Sharma 14 , Arjun Baidya 15 , Animesh Maiti 16 , Ambana Gowda 17 , Jayesh Ambaliya 18 , Balachandra Giriappa K 19 , Sunil Mahavar 20 , Hemant Gupta 21 , Dr Mandodari Rajurkar 22 , Supriya Sonowal 22 , Piyush Patel 23 , Dipak Patil 22 , Lalit Lakhwani 23 , Pravin Ghadge 22 , Suyog Mehta 24 & Sadhna Joglekar 25
1Shivam Hospital, Mumbai, India; 2Maya Hospital & Maternity Centre, Department of General Medicine, Kanpur, India; 3GSVM Medical College, Department of Medicine, Kanpur, India; 4Medstar Speciality Hospital, Bangalore, India; 5Moti lal Nehru Medical College, Department of Medicine, Prayagraj, India; 6District Civil Hospital, Aurangabad, India; 7Hormone Care, Aurangabad, India; 8Global Hospital and Research Institute, Department of Diabetology, Pune, India; 9Priyadarshini Nursing Home, Mumbai, India; 10S. P. Medical College & A.G of Hospitals, Department of medicine, Bikaner, India; 11M.V. Hospitals and Research Center, Department of Medicine, Lucknow, India; 12Victoria Hospital, Department of General Medicine, Bangalore, India; 13Janta Hospital, Varanasi, India; 14Maharaja Agrasen superspeciality Hospital, Department of General Medicine, Jaipur, India; 15Nilratan Sircar Medical College and Hospital, Kolkata, India; 16Medical College and Hospital, Kolkata, India; 17Citizen hospital, Bangalore, India; 18Pagarav Hospital & ICU, Department of Medicine, Gandhinagar, India; 19BGS Global Institute of Medical Sciences, Department of General Medicine, Bangalore, India; 20SMS hospital, Department of Medicine, Jaipur, India; 21Grant Govt. Medical College and Sir J. J. Group of Hospital, Department of Internal Medicine, Mumbai, India; 22Sun Pharma Laboratories Limited, India Clinical Research, Mumbai, India; 23Ex Sun Pharma Laboratories Limited, India Clinical Research, Mumbai, India; 24Sun Pharma Laboratories Limited, Medical Affairs & Clinical Research, Mumbai, India; 25Ex Sun Pharmaceutical Industries Limited, Ex Senior Vice President- Medical Affairs and India Clinical Research, Mumbai, India
Background and Objective: Fixed-dose combination (FDC) of dapagliflozin+metformin+sulfonylurea with complementary mechanisms can provide effective glycaemic control, preserve beta-cell function, improved compliance without risk of weight gain, and reno-protective action in type 2 diabetes mellitus (T2DM) patients. This subgroup analysis aimed to assess efficacy and safety of triple-drug FDC versus (vs) two-drug combination in T2DM Indian patients with HbA1c 9%-11%.
Method: This subgroup analysis of phase 3, open-label, four-arm, active-controlled study (CTRI/2022/06/043249) included T2DM patients (glycated haemoglobin [HbA1c] 9%-11%) taking metformin 1000 mg 2000 mg/day and glimepiride 2 mg/day at screening). Patients received FDC of dapagliflozin+glimepiride+metformin IR tablet twice-daily (BID) (5 mg+1 mg+500 mg [test arm 1]/5 mg+1 mg+1000 mg [test arm 2]) OR co administration of glimepiride tablet + metformin IR BID (1 mg+1 tablet of 500 mg [comparator arm 1]/1 mg+2 tablets of 500 mg [comparator arm 2]) for 16 weeks. Post Week 16, up-titrated dose of glimepiride (2 mg) in respective treatments was provided to patients with HbA1c ≥ 7% in each arm. In this subgroup analysis, change from Baseline in HbA1c, fasting blood glucose (FBG) and post prandial blood glucose (PPBG) till Week 28 and safety parameters were assessed.
Results: This subgroup analysis included 251 patients (58 patients [test arm 1], 67 patients [comparator arm 1], 63 patients each in test arm 2 and comparator arm 2, respectively). Demographic and baseline characteristics were comparable across all arms. Adjusted mean (SE) reduction in HbA1c was statistically significant from Baseline to Week 16 in test arm 1 [-2.15% (0.09%)] vs comparator arm 1 [-1.42% (0.09%)] with difference of 0.73% (P<0.0001) and adjusted mean (SE) reduction in HbA1c was statistically significant from Baseline to Week 16 in test arm 2 [-2.06% (0.09%)] vs comparator arm 2 [ 1.44% (0.09%)], with difference of 0.62% (P<0.0001). Similarly, statistically significant reduction in HbA1c was observed at Weeks 8 and 12. Proportion of patients achieving HbA1c < 7% was significantly higher in test arm 1 vs comparator arm 1 (52.7% vs 29.7%, P=0.0106) and in test arm 2 vs comparator arm 2 (61.9% vs 43.5%, P=0.0398), respectively at Week 16. Significant reduction in HbA1c, FBG and PPBG was observed from Baseline to Weeks 12, 16, and 28 in each arm. None of the patients reported serious adverse events/hypoglycaemia or required rescue medication.
Conclusion: In this subgroup analysis of patients with HbA1c 9%-11%, triple FDCs of dapagliflozin+glimepiride+metformin IR tablets showed statistically significant reduction in HbA1c from Baseline to Weeks 8, 12, 16 as compared to two-drug combination. Both treatments were well tolerated.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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