Efficacy and safety of saxagliptin in older patients with type 2 diabetes mellitus

Abstract

Objective:

To assess the safety and efficacy of saxagliptin (5 mg once-daily) in older patients (≥65 years of age) with inadequately controlled type 2 diabetes.

Research design and methods:

In this retrospective subgroup analysis, data from five randomized, double-blind, placebo-controlled, multicenter, 24-week, phase 3 trials were included. The primary studies evaluated saxagliptin 5 mg once-daily (monotherapy or add-on) in patients aged 18–77 years with HbA_1c ≥7.0% (four studies) or ≥7.5% (add-on to glyburide study) versus placebo.

Main outcome measures:

The primary efficacy endpoint of each study included in this pooled analysis was HbA_1c change from baseline to week 24.

Results:

In the five-study pooled population, 279 (16.6%) patients were at least 65 years old; 142 received saxagliptin 5 mg once-daily and 137 received placebo. Treatment groups were well-balanced for baseline characteristics within each study. In older patients, the HbA_1c adjusted mean change from a baseline of 8.1% was −0.73 ± 0.16% (mean ± SEM) with saxagliptin compared with −0.17 ± 0.14% for placebo from a baseline of 8.0%. Adverse event rates were similar with saxagliptin 5 mg once-daily compared with placebo in older patients.

Conclusion:

The pooled subgroup analysis of saxagliptin 5 mg once-daily monotherapy and add-on therapy trials demonstrated clinically relevant and significant efficacy for reducing HbA_1c in older (≥65 years) patients. Saxagliptin was well-tolerated in older patients with a low incidence of hypoglycemia and no weight gain.

Key words::

• Saxagliptin
• Type 2 diabetes
• Elderly
• Clinical trials

Transparency

Declaration of funding

These studies were sponsored by AstraZeneca and Bristol-Myers Squibb.

Declaration of financial/other relationships

J.D. has received meeting grants from Novo Nordisk and Merck-Serono and grant support from Novo Nordisk, Bristol-Myers Squibb, Merck-Serono and Servier.

A.C. has received research grants from Roche, Novartis, Novo Nordisk, Eli Lilly, AZ/BMS, Boehringer-Ingelheim, MSD and has served on advisory boards of MSD, Novo Nordisk, Boehringer-Ingelheim and Eli Lilly.

P.M., J.L. and S.H. are all employees of AstraZeneca.

J.R. has served on advisory boards and received honorarium or consulting fees from Pfizer, Roche, sanofi-aventis, Novo Nordisk, Eli Lilly, MannKind, GlaxoSmithKline, Takeda, Daiichi Sankyo, Forest, Johnson & Johnson, Novartis, Boehringer Ingelheim, and Amylin. He has received research grants from Merck, Pfizer, sanofi-aventis, Novo Nordisk, Roche, Bristol-Myers Squibb, Eli Lilly, Forest, GlaxoSmithKline, Takeda, Novartis, AstraZeneca, Amylin, Johnson & Johnson, Daiichi Sankyo, MannKind, and Boehringer Ingelheim.

Peer reviewers may receive honoraria from CMRO for their review work. No relevant financial relationships have been declared for any peer reviewer for this paper.

Acknowledgments

The authors thank Rachel Mayers, MA, consultant medical writer, Max Frenzel, PhD and Nikki Kendrick, BSc, from QXV Communications, Macclesfield, UK, for their assistance in the manuscript preparation which was funded by AstraZeneca.

This study was presented in abstract form at the European Association for the Study of Diabetes (EASD) Annual Meeting, Vienna, Austria. 27 September – 1 October 2009.