Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00504673
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The purpose of the trial is to investigate the effect of insulin detemir on weight change in overweight and obese patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2007-07-19
• Study First Submitted QC: 2007-07-19
• Study First Posted: 2007-07-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

Inclusion Criteria

• HbA1c: 7.5-11.0%
• BMI: 25-40 kg/m2

Exclusion Criteria

• Treatment with any OAD (Oral Antidiabetic Drugs) except metformin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body weight loss	after 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
HbA1c
Incidence of hypoglycaemia