Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1

• Registration Number: NCT00117780
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-08
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

• Type 1 diabetes for more than 1 year
• Subject treated by any kind of insulin regimen and whatever the number of injections
• HbA1c = 7.5% and = 10%

Exclusion Criteria

• Type 2 diabetes
• Treatment by oral anti-diabetic drugs
• Severe medical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean HbA1c	after 4 months of insulin detemir treatment

Secondary Outcome Measures

Name	Time	Method
HbA1c
Adverse events
Weight
Hypoglycaemia
Blood glucose
Insulin dose requirements during initial 4 months of treatment and during 3 months extension

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇱🇺 Luxembourg, Luxembourg