Disclosures Professor Michael Nauck has received honoraria from Takeda for serving on advisory boards and presenting data on alogliptin treatment. Professor Nauck has also received honoraria from Merck & Co., Bristol-Myers Squibb, GlaxoSmithKline, Merck (Darmstadt), Novartis, Probiodrug and Roche for similar activities concerning other DPP-4 inhibitors. Dr Graham Ellis has received honoraria from Novartis, South Africa for serving on their vildagliptin advisory board. The remaining authors are employed by Takeda Global Research & Development Center, Inc., the company that funded this study and manufacturer of alogliptin (see affiliations). Clinical Trials.gov ID No.: NCT00286442
Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study
Article first published online: 15 DEC 2008
© 2008 The Authors. Journal compilation © 2008 Blackwell Publishing Ltd
International Journal of Clinical Practice
Volume 63, Issue 1, pages 46–55, January 2009
How to Cite
Nauck, M. A., Ellis, G. C., Fleck, P. R., Wilson, C. A., Mekki, Q. and for the Alogliptin Study 008 Group (2009), Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. International Journal of Clinical Practice, 63: 46–55. doi: 10.1111/j.1742-1241.2008.01933.x
- Issue published online: 15 DEC 2008
- Article first published online: 15 DEC 2008
- Paper received August 2008, accepted August 2008
Aims: To evaluate the efficacy and safety of alogliptin, a new dipeptidyl peptidase-4 inhibitor, for 26 weeks at once-daily doses of 12.5 and 25 mg in combination with metformin in patients whose HbA1c levels were inadequately controlled on metformin alone.
Methods and patients: Patients with type 2 diabetes and inadequate glycaemic control (HbA1c 7.0-10.0%) were randomised to continue a stable daily metformin dose regimen (≥ 1500 mg) plus the addition of placebo (n = 104) or alogliptin at once-daily doses of 12.5 (n = 213) or 25 mg (n = 210). HbA1c, insulin, proinsulin, C-peptide and fasting plasma glucose (FPG) concentrations were determined over a period of 26 weeks.
Results: Alogliptin at either dose produced least squares mean (SE) decreases from baseline in HbA1c of −0.6 (0.1)% and in FPG of −17.0 (2.5) mg/dl [−1.0 (0.1) mmol/l], decreases that were significantly (p < 0.001) greater than those observed with placebo. The between treatment differences (alogliptin – placebo) in FPG reached statistical significance (p < 0.001) as early as week 1 and persisted for the duration of the study. Overall, adverse events (AEs) observed with alogliptin were not substantially different from those observed with placebo. This includes low event rates for gastrointestinal side effects and hypoglycaemic episodes. There was no dose-related pattern of AE reporting between alogliptin groups and few serious AEs were reported.
Conclusion: Alogliptin is an effective and safe treatment for type 2 diabetes when added to metformin for patients not sufficiently controlled on metformin monotherapy.