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Sodium-Glucose Cotransport Inhibition With Dapagliflozin in Type 2 Diabetes

Diabetes Care
American Diabetes Association
Publication Date
DOI: 10.2337/dc08-1863
  • Original Research
  • Emerging Treatments And Technologies
  • Medicine


Sodium-Glucose Cotransport Inhibition With Dapagliflozin in Type 2 Diabetes JAMES F. LIST, MD, PHD1 VINCENT WOO, MD2 ENRIQUE MORALES, MD3 WEIHUA TANG, PHD4 FRED T. FIEDOREK, MD1 OBJECTIVE— Dapagliflozin, a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose study we evaluated the safety and efficacy of dapagliflozin in type 2 diabetic patients. RESEARCH DESIGN AND METHODS— Type 2 diabetic patients were randomly assigned to one of five dapagliflozin doses, metformin XR, or placebo for 12 weeks. The primary objective was to compare mean change from baseline in A1C. Other objectives included com- parison of changes in fasting plasma glucose (FPG), weight, adverse events, and laboratory measurements. RESULTS— After 12 weeks, dapagliflozin induced moderate glucosuria (52–85 g urinary glucose/day) and demonstrated significant glycemic improvements versus placebo (�A1C �0.55 to�0.90% and �FPG�16 to�31 mg/dl). Weight loss change versus placebo was�1.3 to �2.0 kg. There was no change in renal function. Serum uric acid decreased, serum magne- sium increased, serum phosphate increased at higher doses, and dose-related 24-h urine volume and hematocrit increased, all of small magnitude. Treatment-emergent adverse events were similar across all groups. CONCLUSIONS— Dapagliflozin improved hyperglycemia and facilitates weight loss in type 2 diabetic patients by inducing controlled glucosuria with urinary loss of �200–300 kcal/day. Dapagliflozin treatment demonstrated no persistent, clinically significant osmolarity, volume, or renal status changes. Diabetes Care 32:650–657, 2009 T ype 2 diabetes is characterized byhyperglycemia, which contributesto micro- and macrovascular com- plications including retinopathy, ne- phropathy, neuropathy, and accelerated cardiovascular disease (1–4). Excess hy- perglycemia promotes glucotoxicity through increased insulin resistance and interf

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