Trial intelligence / Profile preview

BEGIN BB T1: Insulin Degludec vs Detemir in Type 1 Diabetes

NCT01074268Phase 3

Key facts

Status: Completed
Start: Feb 2010
Primary completion: Dec 2010
Countries: 8
Sponsor: Novo Nordisk
Modality: Recombinant Proteins and Enzymes

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

Overview

Phase 3, randomised, open-label trial of insulin degludec in type 1 diabetes mellitus (T1D) (2 arms), sponsored by Novo Nordisk. Primary endpoints: Change in Glycosylated Haemoglobin at 26 weeks and Rate of Treatment Emergent Adverse Events at 52 weeks. Started Feb 2010; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Insulin Degludec
Insulin degludec once daily + Insulin aspart
Insulin Detemir
Insulin detemir once or twice daily + Insulin aspart

Who it enrols

Adults with Type 1 Diabetes Mellitus for at least 12 months, treated with basal-bolus insulin for at least 12 months, with HbA1c <= 10.0% and BMI <= 35.0 kg/m^2.

Endpoints

Primary

Change in Glycosylated Haemoglobin26 weeks
Rate of Treatment Emergent Adverse Events52 weeks

Secondary

Change in Glycosylated Haemoglobin52 weeks
Self Measured Plasma Glucose Profile52 weeks
Fasting Plasma Glucose52 weeks
Rate of Confirmed Hypoglycaemic Episodes52 weeks

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