Observational Study on Levemir® in Obese Diabetic Patients

Diabetes Mellitus, Type 2 Clinical Trial

— KILOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849342
• Other study ID #: NN304-3708
• Status: Completed
• Phase: N/A
• First received: February 20, 2009
• Last updated: August 13, 2014
• Start date: December 2008
• Est. completion date: January 2013

Study information

• Verified date: July 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board, Dutch Health Care InspectorateSlovenia: Not required for observational study
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: January 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Netherlands,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight and BMI		during 12 months of treatment	No
Secondary	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	No
Secondary	Change in waist perimeter		from insulin start and after 6 and 12 months of treatment	No
Secondary	Change in FPG (Fasting Plasma Glucose)		from 12 and 6 months before treatment after 6 and 12 months of treatment	No
Secondary	Change in HbA1C		from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment	No
Secondary	Change in number of hypoglycaemic events during 4 weeks proceeding routine visits		after 6 and 12 months of treatment	No
Secondary	Number of adverse drug reactions (ADR)		after 6 and 12 months of treatment	Yes
Secondary	Change in blood pressure		from insulin start and 6 and 12 months after treatment	No

External Links

•   Clinical Trials at Novo Nordisk