Trial intelligence / Profile preview

Wosulin vs Novolin in Type 1 Diabetes

NCT01308437Phase 3

Key facts

Status: Terminated
Start: Mar 2011
Primary completion: Apr 2013
Countries: 2
Sponsor: Wockhardt
Modality: Peptides

Drugs: insulin icodec
Conditions: type 1 diabetes mellitus (T1D)

Overview

Phase 3, randomised, open-label trial of insulin icodec in type 1 diabetes mellitus (T1D) (2 arms), sponsored by Wockhardt. Primary endpoint: Change in Glycosylated Hemoglobin at 6 months. Started Mar 2011; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

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

Who it enrols

Adult patients with Type 1 Diabetes on stable insulin regimen for at least 3 months, excluding those with recent use of Wosulin or Novolin.

Endpoints

Primary

Change in Glycosylated Hemoglobin6 months

Secondary

Change in Serum Anti-Insulin Antibodies6 months
Change in Insulin Neutralizing Antibodies6 months
Change in Insulin Dose6 months
Correlation of Immunogenicity with Hypoglycemia12 months
Correlation of Immunogenicity with Allergic Reactions12 months

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