drugset / Trial / NCT00065130
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in the United States of America (USA). The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.
Timeline
- Start
- 2000-04
- Primary completion
- 2003-12
- Completion
- 2003-12
Publications
- Results Pettitt DJ, Ospina P, Kolaczynski JW, Jovanovic L. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care. 2003 Jan;26(1):183-6. doi: 10.2337/diacare.26.1.183.
- Results Pettitt DJ, Ospina P, Howard C, Zisser H, Jovanovic L. Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus. Diabet Med. 2007 Oct;24(10):1129-35. doi: 10.1111/j.1464-5491.2007.02247.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | — | — |
| Subject | insulin aspart | Protein / enzyme biologic | — | — |
| Background | insulin NPH | Protein / enzyme biologic | — | — |