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OpenTrials
Completed

NCT Number: NCT00697450

Observational Study on the Weight Effect of Insulin Detemir (Levemir®) in Type 2 Diabetics

This study is conducted in Europe. Observational study evaluating the body weight progress during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated with other basal insulins

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Prague, 16000, Czechia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Current treatment with insulin NPH or glargine
  • The selection of the subjects will be at the discretion of the individual physician

Exclusion criteria

  • Current treatment with insulin detemir
  • Previous enrolment in this study
  • 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

Treatment and study plan

insulin detemir

Drug

Start dose, frequency of dosing, dose titration to be prescribed by the physician as a result of a normal clinical evaluation

Primary outcomes

  1. Weight effect

    Time frame: 12 months prior to and 12 months after detemir treatment.

Secondary outcomes

  1. Improvement in FPG levels

    Time frame: 12 months prior and 12 months after detemir treatment

  2. Improvement in HbA1c levels

    Time frame: 12 months prior and 12 months after detemir treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Observational Study Evaluating the Body Weight Progress During the Treatment With Insulin Detemir (Levemir®) in Type 2 Patients, Previously Treated With Other Basal Insulins

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 13, 2008
Registry last updated
Nov 23, 2016

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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