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NCT00752180
A Single Dose,Single Centre,Double Blind,Crossover Study Comparing the Pharmacokinetic Profiles of Wockhardt's Insulin Human Injection, Soluble (Recombinant DNA Origin) for Injection and Actrapid in Type 1 Diabetics
Phase 1 trial testing Wosulin R in Diabetes in 28 participants. Completed in 1 April 2009.
1 March 2009
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 | 28 |
| Start date | 1 August 2008 |
| Primary completion | 1 March 2009 |
| Estimated completion | 1 April 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Diabetes — all drugs for Diabetes →
Sponsor
Wockhardt — full company profile →
Who can join
Adults 18 to 45, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mean AUCins.0-12h and Cins.max
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:
- PubMed search for NCT00752180
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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)
- Trial protocol + status: ClinicalTrials.gov NCT00752180 (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/NCT00752180.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing