Who is sponsoring NCT01357603?

NCT01357603 is sponsored by Wockhardt.

What condition does NCT01357603 study?

NCT01357603 studies Type1 Diabetes.

What is the status of NCT01357603?

NCT01357603 is currently COMPLETED.

Last reviewed 2013-01-24 · How we verify

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

NCT01357603 Phase 1 COMPLETED

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.

Details

Lead sponsor	Wockhardt
Phase	Phase 1
Status	COMPLETED
Enrolment	111
Start date	2011-06
Completion	2012-08

Conditions

Type1 Diabetes

Interventions

Glargine

Primary outcomes

Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h. — over 24hrs post dose
Bioequivalence based on Pharmacodynamic parameter: AUC GIR 0-24hrs — over 24hrs post dose
Pharmacokinetic Parameters: Maximum concentration (Cmax) — over 24hrs post dose

Countries

United States