Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment

Summary

This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.

Timeline

Start

2009-04

Primary completion

2010-08

Completion

2010-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Insulin Detemir vs Insulin NPH; p = 0.849; Mean Difference (Final Values) -0.645 (95% CI -7.404 to 6.114); NCT00795600 ↗

registry analysis (superiority or other test); Insulin Detemir vs Insulin NPH; p = 0.948; Mean Difference (Final Values) -0.590 (95% CI -7.588 to 6.407); NCT00795600 ↗

registry analysis (superiority or other test); Insulin Detemir vs Insulin NPH; p = 0.696; Mean Difference (Final Values) 196.36 (95% CI -805.8 to 1198.5); NCT00795600 ↗

registry analysis (superiority or other test); Insulin Detemir vs Insulin NPH; p = 0.710; Mean Difference (Final Values) 192.81 (95% CI -844.0 to 1229.7); NCT00795600 ↗

Publications

• Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	insulin NPH	Protein / enzyme biologic	—	Subcutaneous
Subject	insulin detemir	Protein / enzyme biologic	—	Subcutaneous

Indications