Neil Skolnik1,2, Harmony Bonnes1, Helen Yeh3, Arie Katz3. 1. a Abington Jefferson Health, Family Medicine Residency Program , Jenkintown , PA , USA. 2. b Family and Community Medicine, Temple University School of Medicine , Philadelphia , PA , USA. 3. c AstraZeneca, US Medical Affairs , Fort Washington , PA , USA.
Abstract
OBJECTIVES: 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%. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
RCT Entities:
OBJECTIVES: 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%. METHODS: 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. RESULTS: 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. CONCLUSION: 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.