Observational Study on Levemir® in Obese Diabetic Patients

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin detemir

• Registration Number: NCT00849342
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. A local extension will be conducted in Slovenia in order to reach the planned 400 patients for the sub-analysis of Slovenian patients.

Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Primary Completion: 2011-04
• Study Completion: 2013-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

• Diabetes mellitus (Type 1 or type 2)
• BMI greater than 27 kg/m^2, or more than 3 kg weight increase since start of insulin therapy

Exclusion Criteria

• Subjects currently being treated with insulin detemir
• Subjects who were previously enrolled in this study;
• Subjects with a 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 Female patients will be reminded to use adequate contraceptive during the study, where is relevant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Change in body weight and BMI	during 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
Change in body weight at different BMI subgroups	at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment
Change in number of hypoglycaemic events during 4 weeks proceeding routine visits	after 6 and 12 months of treatment
Number of adverse drug reactions (ADR)	after 6 and 12 months of treatment
Change in HbA1C	from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment
Change in waist perimeter	from insulin start and after 6 and 12 months of treatment
Change in FPG (Fasting Plasma Glucose)	from 12 and 6 months before treatment after 6 and 12 months of treatment
Change in blood pressure	from insulin start and 6 and 12 months after treatment