drugset / Trial / NCT01486966
Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes. The trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.
Timeline
- Start
- 2011-11
- Primary completion
- 2012-06
- Completion
- 2012-06
Publications
- Results Guo X, Li Q, Shi Y, Bu R, Liu J, Qu S, Gao Y. Efficacy and safety of insulin detemir plus insulin aspart versus NPH insulin plus human soluble insulin with or without metformin in Chinese type 2 diabetes. Chinese J Diabetes 2014; 22 (1)
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | human soluble insulin | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin NPH | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin aspart | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin detemir | Protein / enzyme biologic | — | Subcutaneous |
| Background | Metformin | Small molecule | — | — |