Terminated PHASE3 INTERVENTIONAL 2-arm NCT01308437

Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics

An Open Label,Randomized,Comparison of the Immunogenicity and Safety of Wockhardt's Human Insulin Basal Bolus Regimen With the Novo Nordisk's Yeast Based Human Insulin Basal Bolus Regimens, Marketed in United States, in Type 1 Diabetics.

Sponsor: Wockhardt

Conditions Type I Diabetes

Interventions Novolin® (N or 70/30 with R) Wosulin (N or 70/30 with R)

Updated 8 times since 2017 Last updated: Jun 22, 2023 Started: Mar 31, 2011 Primary completion: Apr 30, 2013 Completion: Apr 30, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Business reasons

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Listed as NCT01308437, this PHASE3 trial focuses on Type I Diabetes and remains terminated or withdrawn. Sponsored by Wockhardt, it has been updated 8 times since 2011, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE3
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
Jul 2023 — Jul 2024 [monthly]

Terminated PHASE3
Jan 2021 — Jul 2023 [monthly]

Terminated PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Terminated PHASE3
Feb 2017 — Jun 2018 [monthly]

Terminated PHASE3
Jan 2017 — Feb 2017 [monthly]

Terminated PHASE3

First recorded

Mar 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Wockhardt

Data source: Wockhardt

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ahmedabad, India , Bangalore, India , Chattanooga, United States , Dearborn, United States , El Paso, United States , Haverhill, United States , Hialeah, United States , Hollywood, United States , Hyderabad, India , Jaipur, India and 13 more locations