A Phase 1, Exploratory, Randomized, Double-Blind, Two-Way Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Subjects With Type 1 Diabetes Mellitus

NCT02506647 Phase 1 COMPLETED

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).

Details

Lead sponsor	Gan and Lee Pharmaceuticals, USA
Phase	Phase 1
Status	COMPLETED
Enrolment	41
Start date	2015-12
Completion	2016-09

Conditions

• Diabetes Mellitus, Type 1

Interventions

• Gan & Lee insulin glargine followed by Lantus
• Lantus followed by Gan & Lee insulin glargine

Primary outcomes

• Pharmacodynamic effects — 0-24 hours
  Pharmacodynamic effects: Area under the glucose infusion rate, AUC GIR(0-24hr)
• Pharmacokinetic effects — 0-24 hours
  Area under the insulin concentration-time curve, AUCINS (0-24hr)

Countries

United States