drugset / Trial / NCT00504673
Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Europe. The purpose of the trial is to investigate the effect of insulin detemir on weight change in overweight and obese patients with type 2 diabetes.
Timeline
- Start
- 2005-04
- Primary completion
- 2006-12
- Completion
- 2006-12
Outcome
Met primary endpoint
paper At 26 weeks, weight had increased significantly less with detemir (0.4 kg) than with NPH (1.9 kg; difference 1.5 kg, P < 0.0001). PMID 18959604 ↗
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.
- Fajardo Montanana C, Hernandez Herrero C, Rivas Fernandez M. Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight Type 2 diabetes patients: the PREDICTIVE BMI clinical trial. Diabet Med. 2008 Aug;25(8):916-23. doi: 10.1111/j.1464-5491.2008.02483.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin NPH | Protein / enzyme biologic | — | — |
| Subject | insulin detemir | Protein / enzyme biologic | — | — |
| Background | insulin aspart | Protein / enzyme biologic | — | — |