NCT00719108 is a Phase 1 clinical trial of Wosulin R in Diabetes, sponsored by Wockhardt.

Who is sponsoring NCT00719108?

NCT00719108 is sponsored by Wockhardt.

What drugs are being tested in NCT00719108?

Interventions in NCT00719108: Wosulin R, Actrapid.

Is NCT00719108 still recruiting?

NCT00719108 is currently completed. Last updated 26 December 2012.

Last reviewed 2012-12-26 · How we verify

NCT00719108

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial to Test Bioequivalence Between Two Recombinant Human Soluble Insulins - Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects

Completed Phase 1 Last updated 26 December 2012

What this trial tests

Phase 1 trial testing Wosulin R in Diabetes in 42 participants. Completed in 1 September 2008.

Timeline

1 July 2008

Primary endpoint
1 September 2008

1 September 2008

Quick facts

Lead sponsor	Wockhardt
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	health services research
Enrollment	42
Start date	1 July 2008
Primary completion	1 September 2008
Estimated completion	1 September 2008
Sites	1 location across United States

Drugs / interventions tested

Wosulin R — full drug profile →
Actrapid — full drug profile →

Conditions studied

Diabetes — all drugs for Diabetes →

Sponsor

Wockhardt — full company profile →

Who can join

Adults 18 to 45, any sex, with Diabetes. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The area under the GIR-time curve at steady state from 240 to 300 minutes (AUCGIR-SS)
Time frame: Visit 2 and 3

Sponsor's own description

The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard to its total and to its maximum serum insulin concentrations.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The emergence of biosimilar insulin preparations--a cause for concern?
Owens DR, Landgraf W, Schmidt A, Bretzel RG, et al · · 2012 · cited 45× · PMID 23046400 · DOI 10.1089/dia.2012.0105

Verify or expand the search:

Other recruiting trials for Diabetes

Currently open trials in the same condition.

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NCT07441655 — Families Implementing Good Health Traditions for Life · NA · recruiting
NCT06724172 — CHIME: Comparing Health Interventions for Maternal Equity · NA · recruiting
NCT07417865 — ECHO Diabetes FQHC · recruiting

Other Wockhardt trials

Trials by the same sponsor.

NCT06806995 — A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Met · Phase 1 · completed
NCT04979806 — Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) · Phase 3 · completed
NCT03981887 — Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin · Phase 1 · completed
NCT03622008 — To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) · Phase 1 · completed
NCT07247942 — Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion. · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00719108 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wockhardt
Last refreshed: 26 December 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00719108.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing