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

Observational Study on Levemir® in Obese Diabetic Patients

Sponsors

Lead sponsor: Novo Nordisk A/S

Source 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.

Overall Status Completed
Start Date December 2008
Completion Date January 2013
Primary Completion Date April 2011
Study Type Observational
Primary Outcome
Measure Time Frame
Change in body weight and BMI during 12 months of treatment
Secondary Outcome
Measure Time Frame
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 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 HbA1C from insulin start and 12 and 6 months before treatment and after 6 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 blood pressure from insulin start and 6 and 12 months after treatment
Enrollment 580
Condition
Intervention

Intervention type: Drug

Intervention name: insulin detemir

Description: Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.

Arm group label: A

Eligibility

Sampling method: Non-Probability Sample

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.

Gender: All

Minimum age: 6 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
facility
| Alphen a/d Rijn, Netherlands
| Ljubljana, SI-1000, Slovenia
Location Countries

Netherlands

Slovenia

Verification Date

July 2014

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: A

Acronym KILOS
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov