A Prospective, Multicentre, Non-controlled, Observational, 52-weeks Study: the Evaluation of the Body Weight Progress During the Treatment With Insulin Detemir in Type 1 or 2 Diabetes Patients, Previously Treated With Other Basal Insulins

Novo Nordisk A/S0 sites580 target enrollmentDecember 2008

ConditionsDiabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventionsinsulin detemir

Drugsinsulin detemir

Overview

Phase: Not Applicable
Intervention: insulin detemir
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 580
Primary Endpoint: Change in body weight and BMI
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

January 2013

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

A

Intervention: insulin detemir

Outcomes

Primary Outcomes

Change in body weight and BMI

Time Frame: during 12 months of treatment

Secondary Outcomes

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)