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Completed

NCT Number: NCT00849342

Observational Study on Levemir® in Obese Diabetic Patients

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alphen aan den Rijn, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin detemir

Drug

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

Primary outcomes

  1. Change in body weight and BMI

    Time frame: during 12 months of treatment

Secondary outcomes

  1. Change in body weight at different BMI subgroups

    Time frame: at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment

  2. Change in waist perimeter

    Time frame: from insulin start and after 6 and 12 months of treatment

  3. Change in FPG (Fasting Plasma Glucose)

    Time frame: from 12 and 6 months before treatment after 6 and 12 months of treatment

  4. Change in HbA1C

    Time frame: from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment

  5. Change in number of hypoglycaemic events during 4 weeks proceeding routine visits

    Time frame: after 6 and 12 months of treatment

  6. Number of adverse drug reactions (ADR)

    Time frame: after 6 and 12 months of treatment

  7. Change in blood pressure

    Time frame: from insulin start and 6 and 12 months after treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: KILOS

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Feb 23, 2009
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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