Postprandial Dynamics of Plasma Glucose,Insulin, and Glucagon in Patients with Type 2 Diabetes Treated with Saxagliptin Plus Dapagliflozin Add-On to Metformin Therapy |
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| Institution: | 1. From Bristol-Myers Squibb, Princeton, New, Jersey;2. AstraZeneca, Mölndal, Sweden;3. AstraZeneca, Wilmington, Delaware.;1. Departments of Endocrinology, Instituto Português de Oncologia de Lisboa;2. Departments of Nuclear Medicine Department, Instituto Português de Oncologia de Lisboa;3. Departments of University Clinic of Endocrinology, Faculdade de Ciências Médicas, Universidade Nova de Lisboa.;1. Department of Neurosurgery, Unit-I, Vellore, India;2. Department of Endocrinology, Diabetes, and Metabolism, Christian Medical College and Hospital, Vellore, India;1. Department of Clinical and Experimental Medicine, Section of Geriatrics, University of Parma, Italy;2. Geriatric Rehabilitation Department, University Hospital of Parma, Parma, Italy;3. Division of Endocrinology, Diabetes, and Metabolism, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania;4. Department of Psychiatry, VU University Medical Center/GGZ inGeest, Amsterdam, the Netherlands;5. National Institute on Aging, National Institutes of Health, Baltimore, Maryland.;1. Divisions of Endocrinology and General Surgery Departments of Medicine and Surgery, Rutgers Robert Wood Johnson Medical School;2. General Surgery, Departments of Medicine and Surgery, Rutgers Robert Wood Johnson Medical School,;3. Department of Nutritional Sciences, Rutgers University, New Brunswick, New Jersey. |
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| Abstract: | ObjectiveTo analyze changes in plasma glucose, insulin, and glucagon in relation to glycemic response during treatment with dual add-on of saxagliptin (SAXA) plus dapagliflozin (DAPA) to metformin XR (MET) compared with SAXA add-on or DAPA add-on alone to MET in patients with type 2 diabetes mellitus (T2DM) poorly controlled with MET.MethodsDouble-blind trial in adults with glycated hemoglobin (HbAlc) ≥ 8.0 to ≤ 12.0% randomized to SAXA 5 mg/day plus DAPA 10 mg/day (n = 179), or SAXA 5 mg/day and placebo (n = 176), or DAPA 10 mg/day and placebo (n = 179) added to background MET ≥ 1,500 mg/ day. The mean change from baseline in the area under the curve from 0 to 180 minutes (AUC0-180 min) was calculated for glucose, insulin, and glucagon obtained during a liquid meal tolerance test (MTT).ResultsGlucose AUC0-180 min an was reduced more from baseline with SAXA + DAPA + MET (-12,940 mg/dL) compared with SAXA + MET (-6,309 mg/dL) and DAPA + MET (-11,247 mg/dL). Insulin AUC0-180 min significantly decreased with SAXA + DAPA + MET (-1,120 μU/mL) and DAPA + MET (-1,019 μU/mL) and increased with SAXA + MET (661 μU/mL). Glucagon AUC0-180 min only increased with DAPA + MET (2,346 pg/mL). The changes in glucose (P < .0001) and insulin (P = .0003) AUC0-180 min correlated with change in HbA1c, whereas the change in glucagon AUC0-180 min min did not (P = .27).ConclusionsWhen added to background MET, the combination of SAXA + DAPA provided additional reductions in glucose AUC0-180 min and HbA1c without the increase in insulin seen with SAXA and without the increase in glucagon seen with DAPA. Changes in insulin and glucose but not glucagon AUC0-180 min correlated with change in HbA1c. (Endocr Pract. 2014;20:1187-1197) |
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