NCT01357603

Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM

A Randomized, Double-blind, Two Period, Cross Over Glucose Clamp Study to Test for Bioeqivalence Between Two Long Acting Insulin Analogs-Wockhardt's Glaritus™ (Insulin Glargine) and Lantus (Insulin Glargine) in Subjects With Type 1 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to its total and to its maximum serum insulin concentrations.

Detailed description

The purpose of this study is to test for bioequivalence based on the pharmacokinetic parameter AUC INS-GLR 0-24h and on pharmacodynamic parameter AUC GIR 0-24h between the two long-acting insulin glargine formulations, Lantus® and Wockhardt's Glaritus® in subjects with type1 diabetes as well as assessing safety and local tolerability of the two insulin preparations.

Conditions

• Type1 Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	Glargine	dosage form: Subcutaneous injection

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-05-01
• Completion: 2012-08-01
• First posted: 2011-05-20
• Last updated: 2013-01-25

Locations

1 site across 1 country: United States