Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: This was a 24-week parallel-group, double-blind, placebo-controlled phase 3 trial. Patients with A1C 7.0-10% (n = 485) were randomly assigned to one of seven arms to receive once-daily placebo or 2.5, 5, or 10 mg dapagliflozin once daily in the morning (main cohort) or evening (exploratory cohort). Patients with A1C 10.1-12% (high-A1C exploratory cohort; n = 73) were randomly assigned 1:1 to receive blinded treatment with a morning dose of 5 or 10 mg/day dapagliflozin. The primary end point was change from baseline in A1C in the main cohort, statistically tested using an ANCOVA. RESULTS: In the main cohort, mean A1C changes from baseline at week 24 were -0.23% with placebo and -0.58, -0.77 (P = 0.0005 vs. placebo), and -0.89% (P < 0.0001 vs. placebo) with 2.5, 5, and 10 mg dapagliflozin, respectively. Signs, symptoms, and other reports suggestive of urinary tract infections and genital infection were more frequently noted in the dapagliflozin arms. There were no major episodes of hypoglycemia. Data from exploratory cohorts were consistent with these results. CONCLUSIONS:
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Authors | Ele Ferrannini, Silvia Jimenez Ramos, Afshin Salsali, Weihua Tang, James F List |
Journal | Diabetes care
(Diabetes Care)
Vol. 33
Issue 10
Pg. 2217-24
(Oct 2010)
ISSN: 1935-5548 [Electronic] United States |
PMID | 20566676
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Benzhydryl Compounds
- Glucosides
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Placebos
- dapagliflozin
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Topics |
- Benzhydryl Compounds
- Diabetes Mellitus, Type 2
(diet therapy, drug therapy, metabolism, therapy)
- Diet Therapy
- Double-Blind Method
- Exercise Therapy
- Glucosides
(therapeutic use)
- Glycated Hemoglobin
(metabolism)
- Humans
- Hypoglycemic Agents
(therapeutic use)
- Placebos
- Treatment Outcome
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