Efficacy and Safety of the Dipeptidyl Peptidase-4 Inhibitor Alogliptin in Patients With Type 2 Diabetes and Inadequate Glycemic Control
A randomized, double-blind, placebo-controlled study
- Ralph A. DeFronzo, MD1,
- Penny R. Fleck, MT2,
- Craig A. Wilson, PHD2,
- Qais Mekki, MD, PHD2 and
- on behalf of the Alogliptin Study 010 Group*
- 1University of Texas Health Science Center at San Antonio, San Antonio, Texas
- 2Takeda Global Research & Development Center, Deerfield, Illinois
- Corresponding author: Ralph A. DeFronzo, albarado{at}uthscsa.edu
Abstract
OBJECTIVE—To evaluate the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin in drug-naïve patients with inadequately controlled type 2 diabetes.
RESEARCH DESIGN AND METHODS—This double-blind, placebo-controlled, multicenter study included 329 patients with poorly controlled diabetes randomized to once-daily treatment with 12.5 mg alogliptin (n = 133), 25 mg alogliptin (n = 131), or placebo (n = 65) for 26 weeks. Primary efficacy end point was mean change from baseline in A1C at the final visit.
RESULTS—At week 26, mean change in A1C was significantly greater (P < 0.001) for 12.5 mg (−0.56%) and 25 mg (−0.59%) alogliptin than placebo (−0.02%). Reductions in fasting plasma glucose were also greater (P < 0.001) in alogliptin-treated patients than in those receiving placebo. Overall, incidences of adverse events (67.4–70.3%) and hypoglycemia (1.5–3.0%) were similar across treatment groups.
CONCLUSIONS—Alogliptin monotherapy was well tolerated and significantly improved glycemic control in patients with type 2 diabetes, without raising the incidence of hypoglycemia.
Footnotes
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Published ahead of print at http://care.diabetesjournals.org on 22 September 2008. Clinical trial reg. no. NCT00286455, clinicaltrials.gov.
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↵* A full list of investigators of the Alogliptin Study 010 Group is available in an online appendix at http://dx.doi.org/10.2337/dc08-1035.
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- Accepted September 13, 2008.
- Received June 5, 2008.
- DIABETES CARE
