Journal
DIABETES CARE
Volume 35, Issue 7, Pages 1473-1478Publisher
AMER DIABETES ASSOC
DOI: 10.2337/dc11-1693
Keywords
-
Categories
Funding
- Bristol-Myers Squibb [MB102030]
- AstraZeneca [MB102030]
- Pfizer
- Roche
- sanofi-aventis
- Novo Nordisk
- Eli Lilly
- MannKind
- GlaxoSmith Kline
- Takeda
- Daiichi Sankyo
- Johnson Johnson
- Novartis
- Boehringer Ingelheim
- Lexicon
- Amylin
- Merck
- Bristol-Myers Squibb
- Forest
- AstraZeneca
Ask authors/readers for more resources
OBJECTIVE-To examine the safety and efficacy of dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, added on to pioglitazone in type 2 diabetes inadequately controlled on pioglitazone. RESEARCH DESIGN AND METHODS-Treatment-naive patients or those receiving metformin, sulfonylurea, or thiazolidinedione entered a 10-week pioglitazone dose-optimization period with only pioglitazone. They were then randomized, along with patients previously receiving pioglitazone >= 30 mg, to 48 weeks of double-blind dapagliflozin 5 (n = 141) or 10 mg (it = 140) or placebo (n = 139) every day plus open-label pioglitazone. The primary objective compared HbA(1c) change from baseline with dapagliflozin plus pioglitazone versus placebo plus pioglitazone at week 24. Primary analysis was based on ANCOVA model using last observation carried forward; all remaining analyses used repeated-measures analysis. RESULTS-At week 24, the mean reduction from baseline in HbA(1c) was -0.42% for placebo versus -0.82 and -0.97% for dapagliflozin 5 and 10 mg groups, respectively (P = 0.0007 and P < 0.0001 versus placebo). Patients receiving pioglitazone alone had greater weight gain (3 kg) than those receiving dapagliflozin plus pioglitazone (0.7-1.4 kg) at week 48. Through 48 weeks: hypoglycemia was rare; more events suggestive of genital infection were reported with dapagliflozin (8.6-9.2%) than placebo (2.9%); events suggestive of urinary tract infection showed no clear drug effect (5.0-8.5% for dapagliflozin and 7.9% for placebo); dapagliflozin plus pioglitazone groups had less edema (2.1-4.3%) compared with placebo plus pioglitazone (6.5%); and congestive heart failure and fractures were rare. CONCLUSIONS-In patients with type 2 diabetes inadequately controlled on pioglitazone, the addition of dapagliflozin further reduced HbA(1c) clevels and mitigated the pioglitazone-related weight gain without increasing hypoglycemia risk.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available