NCT00596063 is a Phase 1 clinical trial of Wosulin R in Diabetes Mellitus, sponsored by Wockhardt.

Who is sponsoring NCT00596063?

NCT00596063 is sponsored by Wockhardt.

What drugs are being tested in NCT00596063?

Interventions in NCT00596063: Wosulin R, Novolin R.

What condition does NCT00596063 study?

NCT00596063 studies Diabetes Mellitus.

Is NCT00596063 still recruiting?

NCT00596063 is currently completed. Last updated 26 December 2012.

Last reviewed 2012-12-26 · How we verify

NCT00596063

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

A Randomized, Single Center, Double Blind, Two Period, Crossover Glucose Clamp Study to Test for Bioequivalence Between Two Recombinant Human Soluble Insulins- Wockhardts Insulin Human Regular for Injection and Novolin R in Healthy Subjects

Completed Phase 1 Last updated 26 December 2012

What this trial tests

Phase 1 trial testing Wosulin R in Diabetes Mellitus in 25 participants. Completed in 1 February 2008.

Timeline

1 January 2008

Primary endpoint
1 February 2008

1 February 2008

Quick facts

Lead sponsor	Wockhardt
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	25
Start date	1 January 2008
Primary completion	1 February 2008
Estimated completion	1 February 2008
Sites	2 locations across United States

Drugs / interventions tested

Wosulin R — full drug profile →
Novolin R — full drug profile →

Conditions studied

Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Wockhardt — full company profile →

Who can join

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

What's being measured

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

The primary objective is to test for bioequivalence based on AUC0-12h and Cmax between Wockhardt's Insulin Human Regular for injection and Novolin® R
Time frame: Visit 2 & 3

Sponsor's own description

The purpose of this study is the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of euglycemic clamp.

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 Mellitus

Currently open trials in the same condition.

NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07392437 — Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and I · NA · recruiting
NCT07448805 — Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit · NA · recruiting
NCT07425275 — Integrated Oral Care Intervention for Xerostomia in Diabetes Patients · NA · recruiting
NCT06918977 — Improving Glycemic Control With Telemedicine and Smart Insulin Pens · NA · 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 NCT00596063 (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/NCT00596063.

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