The list of study investigators was previously published in Nauck et al. (see Reference #9).
Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study
Article first published online: 4 MAR 2010
© 2010 Blackwell Publishing Ltd
International Journal of Clinical Practice
Volume 64, Issue 5, pages 562–576, April 2010
How to Cite
Seck, T., Nauck, M., Sheng, D., Sunga, S., Davies, M. J., Stein, P. P., Kaufman, K. D., Amatruda, J. M. and for the Sitagliptin Study 024 Group (2010), Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. International Journal of Clinical Practice, 64: 562–576. doi: 10.1111/j.1742-1241.2010.02353.x
ClinicalTrials.gov: NCT00094770 (Sitagliptin Study 024) Clinicalstudyresults.org: JanuviaTM– Merck Protocol Number 024.
Disclosures Michael Nauck, has received honoraria from Merck & Co., Inc. for memberships on the advisory boards and for speaking on subjects related to sitagliptin, DPP-4 inhibitors and incretins in general. He has also received honoraria from Bristol-Myers-Squibb, GlaxoSmithKline, Merck (Darmstadt), Novartis, Probiodrug and Roche for consultations and speaking on topics closely related to sitagliptin and other DPP-4 inhibitors. Thomas Seck, Danielle Sheng, Sheila Sunga, Michael J. Davies, Peter Stein, Keith Kaufman and John Amatruda were employees of Merck & Co., Inc. during the conduct of this study.
- Issue published online: 10 MAR 2010
- Article first published online: 4 MAR 2010
- Paper received December 2009, accepted January 2010
Objectives: To evaluate the 2-year safety and efficacy of adding sitagliptin or glipizide to ongoing metformin in patients with type 2 diabetes.
Methods: Patients who were on a stable dose of metformin (≥ 1500 mg/day) for at least 8 weeks were randomised in a double-blind manner to receive either sitagliptin 100 mg q.d. (N = 588) or glipizide 5 mg/day (up-titrated up to 20 mg/day based upon prespecified glycaemic criteria) (N = 584). The efficacy analysis assessed the change in HbA1c from baseline using the per-protocol (PP) population.
Results: For the PP cohort, mean baseline HbA1c was 7.3% in both groups. After 2 years, the least squares (LS) mean change in HbA1c from baseline [95% confidence interval (CI)] was −0.54% (−0.64, −0.45) with sitagliptin (n = 248) and −0.51% (−0.60, −0.42) with glipizide (n = 256). The rise in HbA1c from week 24 to week 104 [i.e. coefficient of durability (COD)] was smaller with sitagliptin [COD (95% CI) 0.16%/year (0.10, 0.21)] compared with glipizide [0.26%/year (0.21, 0.31)]. The proportion of patients with an HbA1c< 7% was 63% and 59% with sitagliptin and glipizide, respectively. The beta-cell responsiveness to a meal challenge was maintained with sitagliptin and decreased with glipizide. The proportion of patients who reported hypoglycaemia was 5% with sitagliptin and 34% with glipizide [difference in proportions (95% CI) = −29% (−33, −25)]. Relative to baseline, sitagliptin was associated with weight loss (−1.6 kg) compared with weight gain (+0.7 kg) with glipizide.
Conclusion: In patients with type 2 diabetes, adding sitagliptin to metformin monotherapy improved glycaemic control over 2 years, similar to the glucose-lowering efficacy observed with adding glipizide, but with greater durability and generally better maintenance of beta-cell function. Sitagliptin was generally well tolerated with a lower risk of hypoglycaemia and weight loss compared with weight gain observed with glipizide.