drugset / Trial / NCT02506647
PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes
RandomizedCrossoverDouble-blindBasic science
Summary
This is a Phase 1, exploratory, single dose, randomized, double-blind, two-way cross over, pilot, glucose clamp study to assess pharmacokinetic and pharmacodynamic effects of Gan \& Lee's insulin glargine injection in comparison to the marketed Lantus (US) in subjects with type 1 diabetes mellitus (T1DM).
Timeline
- Start
- 2015-12
- Primary completion
- 2016-09
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin glargine | Protein / enzyme biologic | 0.4 iu/kg | Subcutaneous |