Observational Study on the Weight Effect of Insulin Detemir (Levemir®) in Type 2 Diabetics

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin detemir

• Registration Number: NCT00697450
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. Observational study evaluating the body weight progress during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated with other basal insulins

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-13
• Study Start: 2008-07
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• Type 2 diabetes
• Current treatment with insulin NPH or glargine
• The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria

• Current treatment with insulin detemir
• Previous enrolment in this study
• Hypersensitivity to insulin detemir or to any of the excipients.
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Weight effect	12 months prior to and 12 months after detemir treatment.

Secondary Outcome Measures

Name	Time	Method
Improvement in FPG levels	12 months prior and 12 months after detemir treatment
Improvement in HbA1c levels	12 months prior and 12 months after detemir treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇿 Prague, Czech Republic