drugset / Trial / NCT00604253
Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment.
Timeline
- Start
- 2003-12
- Primary completion
- 2005-05
- Completion
- 2005-05
Publications
- Results Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 36-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Once Daily Treatment as an Add-on Current Oral Hypoglycemic Agents. J. Japan Diab. Soc 2007; 50 (9): 665-677
- Results Tajima N, Iwamoto Y, Kaku K, Kawamori R, Nishida T, Kobayashi M. Once-daily insulin detemir added to oral antidiabetic drugs results in less weight gain and a trend for reduced hypoglycaemia in comparison with NPH insulin in Japanese patients with type 2 diabetes. Diabetologia 2006; 49 (Suppl. 1): 609 (Abstract 996)
- 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 |
|---|---|---|---|---|
| Subject | insulin NPH | Protein / enzyme biologic | — | — |
| Subject | insulin detemir | Protein / enzyme biologic | — | — |