Dapagliflozin in the treatment of patients with type 2 diabetes presenting with high baseline A1C

• Published in: Postgraduate medicine Vol. 128; no. 4; p. 356
• Main Authors: Skolnik, Neil, Bonnes, Harmony, Yeh, Helen, Katz, Arie
• Format: Journal Article
• Language: English
• Published: England 18.05.2016
• Subjects: Adult; Aged; Benzhydryl Compounds - administration & dosage; Benzhydryl Compounds - adverse effects; Blood Glucose - metabolism; Blood Pressure - drug effects; Body Weight; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Female; Glucosides - administration & dosage; Glucosides - adverse effects; Glycated Hemoglobin A - metabolism; Humans; Hypoglycemia - chemically induced; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Male; Middle Aged; Randomized Controlled Trials as Topic; Retrospective Studies; A1C; type 2 diabetes; sodium-glucose cotransporter-2 inhibitor; dapagliflozin; post-hoc analysis
• ISSN: 1941-9260
• DOI: 10.1080/00325481.2016.1173514

To evaluate the efficacy and safety of dapagliflozin 5 and 10 mg/d versus placebo in patients with type 2 diabetes and high baseline A1C defined as A1C ≥ 9% or ≥ 10%. A post-hoc analysis was conducted of pooled data from 9, 24-week, placebo-controlled clinical studies investigating dapagliflozin as monotherapy, add-on therapy to other oral antidiabetes drugs or insulin, or initial combination therapy with metformin. At week 24, dapagliflozin 5 and 10 mg/d decreased A1C (≥ 9%: -1.37% and -1.39%, respectively, vs. -0.65% with placebo, both P < 0.0001 and ≥ 10%: -2.13% [P < 0.0001] and -1.59% [P = 0.0003], respectively, vs. -0.82% with placebo), reduced fasting plasma glucose as early as week 1 (P < 0.001 for each dose at all time points for both treatments), and decreased body weight (≥ 9%: P < 0.0001 vs. placebo for both doses; ≥ 10%: P = 0.0065 vs. placebo, 10 mg/d only). Among patients with baseline A1C ≥ 9% who received dapagliflozin 5 or 10 mg/d, 15.7% and 18.9%, respectively, achieved a ≥ 5% decrease in body weight (both P < 0.0001 vs. 3.6% with placebo). Dapagliflozin 10 mg/d decreased systolic and diastolic blood pressure (P < 0.0001 and P = 0.0074 vs. placebo). Adverse events were generally similar across treatment groups, with the exception of a greater frequency of genital infections and hypoglycemia (mostly minor episodes not requiring third-party assistance) in patients receiving dapagliflozin. In patients with poorly controlled type 2 diabetes defined as A1C ≥ 9% or ≥ 10%, dapagliflozin provided clinically meaningful improvements in glycemic parameters, body weight, and blood pressure, and was generally well tolerated, making it a good therapeutic option for patients with high A1C.