Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1

• Registration Number: NCT00595374
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe.

The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12-02
• Primary Completion: 2004-10-07
• Study Completion: 2004-10-07
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Duration of type 1 diabetes for at least 12 months
• BMI below 35 kg/m2
• HbA1c between 7.0-12.0%
• Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
• Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

Exclusion Criteria

• Known or suspected allergy to trial product or related products
• Previous participation in this trial
• Receipt of any investigational products within the last 2 months prior to this trial
• Drug or alcohol dependence
• Pregnancy, breast-feeding or intention of becoming pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of hypoglycaemic episodes
Plasma glucose profiles
Change in body weight
Quality of Life
Incidence of adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇳🇱 Zwolle, Netherlands