Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes

• Registration Number: NCT00283751
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2006-01-27
• Study First Submitted QC: 2006-01-27
• Study First Posted: 2006-01-30
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 583

Inclusion Criteria

• Type 2 Diabetes for more than 12 months, and no previous insulin treatment
• Oral Antidiabetic Drug treatment for at least 4 months
• Body Mass Index (BMI) less than 40 kg/m2
• HbA1c 7.5-10.0%

Exclusion Criteria

• Current or previous treatment with thiazolidinediones within the last 6 months
• Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
• Proliferative retinopathy or maculopathy
• Known hypoglycaemia unawareness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 52 weeks

Secondary Outcome Measures

Name	Time	Method
Insulin antibodies
Plasma glucose profiles
Incident of hypoglycaemic episodes and adverse events
Change in body weight

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Swansea, United Kingdom