NCT02506647

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Gan & Lee insulin glargine followed by Lantus	0.4 IU/kg Gan \& Lee insulin glargine injection SC, Lantus 0.4 IU/kg injection SC
DRUG	Lantus followed by Gan & Lee insulin glargine	Lantus 0.4 IU/kg injection SC, 0.4 IU/kg Gan \& Lee insulin glargine injection SC,

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-07-23
• Last updated: 2017-01-26

Locations

1 site across 1 country: United States