drugset / Trial / NCT00184665
Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).
Timeline
- Start
- 2004-06
- Primary completion
- 2006-09
- Completion
- 2006-09
Publications
- Results Bartley PC, Bogoev M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med. 2008 Apr;25(4):442-9. doi: 10.1111/j.1464-5491.2007.02407.x.
- Results Gschwend MH, Aagren M, Valentine WJ. Cost-effectiveness of insulin detemir compared with neutral protamine Hagedorn insulin in patients with type 1 diabetes using a basal-bolus regimen in five European countries. J Med Econ. 2009 Jun;12(2):114-23. doi: 10.3111/13696990903080344.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin NPH | Protein / enzyme biologic | — | — |
| Subject | insulin detemir | Protein / enzyme biologic | — | — |
| Background | insulin aspart | Protein / enzyme biologic | — | — |