drugset / Trial / NCT02506647

PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes

NCT02506647

Phase 1 Completed 41 enrolled Gan and Lee Pharmaceuticals, USA
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

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic 0.4 iu/kg Subcutaneous