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NCT01357603 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Wockhardt.

Completed
Registry status
Phase 1
Development phase
111
Enrollment target

NCT01357603: Completed Phase 1 study, sponsored by Wockhardt.

NCT01357603 is a Phase 1 study that has completed, run by Wockhardt. The registered enrollment target is 111 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01357603, a Phase 1 study, has completed, sponsored by Wockhardt.

COMPLETED
Registry status
Phase 1
Development phase
111 participants
Enrollment target

Study 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.

Interventions

  • BIOLOGICAL Glargine

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2011-06
Est. Completion 2012-08
Phase Phase 1
Wockhardt

27 total trials

What the finished NCT01357603 record still lists

NCT01357603 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% higher).

The record links to 0 conditions, and to 1 intervention - of which Glargine is the first listed.

NCT01357603 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01357603 about?

NCT01357603 is a clinical study titled "Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM". 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.

What is the current status of trial NCT01357603?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2011-06. Estimated completion is 2012-08.

What interventions are being tested in trial NCT01357603?

The interventions under investigation include: Glargine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01357603?

This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01357603's enrollment target sits among peer trials

111 512th of 2000 higher than 1,487 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01357603, the US trial registry maintained by the National Library of Medicine. NCT01357603 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.