Lower Risk of Hypoglycemia with Insulin Detemir than with Neutral Protamine Hagedorn Insulin in Older Persons with Type 2 Diabetes: A Pooled Analysis of Phase III Trials
Article first published online: 29 OCT 2007
Journal of the American Geriatrics Society
Volume 55, Issue 11, pages 1735–1740, November 2007
How to Cite
Garber, A. J., Clauson, P., Pedersen, C. B. and Kølendorf, K. (2007), Lower Risk of Hypoglycemia with Insulin Detemir than with Neutral Protamine Hagedorn Insulin in Older Persons with Type 2 Diabetes: A Pooled Analysis of Phase III Trials. Journal of the American Geriatrics Society, 55: 1735–1740. doi: 10.1111/j.1532-5415.2007.01414.x
- Issue published online: 29 OCT 2007
- Article first published online: 29 OCT 2007
- type 2 diabetes mellitus
OBJECTIVES: To compare the safety and efficacy of insulin detemir with that of neutral protamine Hagedorn (NPH) insulin in older (aged ≥65) and younger (aged 18–64) persons with type 2 diabetes mellitus (DM).
DESIGN: Pooled, post hoc analysis of data from three open-label, randomized studies.
SETTING: Three multinational Phase III trials.
PARTICIPANTS: Four hundred sixteen older and 880 younger persons with DM, treated for 22 to 26 weeks with basal insulin plus mealtime insulin or oral agents.
MEASUREMENTS: Hemoglobin A1c (HbA1c), fasting plasma glucose, glucose variability, hypoglycemic episodes.
RESULTS: Mean treatment difference for HbA1c (insulin detemir–NPH insulin) indicated that insulin detemir was not inferior to NPH insulin for both age groups (0.035%, 95% confidence interval (CI)=−0.114–0.183 and 0.100%, 95% CI=−0.017–0.217, for older and younger persons, respectively). Relative risk of all hypoglycemic episodes (insulin detemir/NPH insulin) was 0.59 (95% CI-0.42–0.83) for older persons and 0.75 (95% CI-0.59–0.96) for younger persons. Adverse events were similar between treatments. Fasting plasma glucose was similar between treatments (mean treatment difference 0.97 mg/dL, 95% CI=−8.01–9.95, and 4.69 mg/dL, 95% CI=−2.30–11.67, for older and younger persons, respectively). Mean treatment difference for weight was −1.02 kg (95% CI −1.61 to −0.42) and −1.13 (95% CI −1.58 to −0.69) for older and younger persons, respectively.
CONCLUSION: Previously reported benefits of insulin detemir, particularly less hypoglycemia and less weight gain, compared with NPH insulin, were the same for older and younger persons with DM at similar levels of HbA1c.