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Completed

NCT Number: NCT00676741

Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin

The study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for the treatment type 2 diabetes.

Full acronym for this study: COMMIT - CLEAN SWITCH

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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

Bratislava, 811 05, Slovakia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with type 2 diabetes
  • Patients treated with human soluble insulin, NPH insulin or premixed human insulin
  • Patients willing to sign informed consent
  • Selection of study participants at the discretion of the physician

Exclusion criteria

  • Subjects currently being treated with insulin aspart, insulin detemir or biphasic insulin aspart 30
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients

Treatment and study plan

insulin aspart

Drug

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

Other names: NovoRapid®

biphasic insulin aspart 30

Drug

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

insulin detemir

Drug

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

Primary outcomes

  1. Metabolic control measured as HbA1c

    Time frame: for the duration of the study

Secondary outcomes

  1. Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5%

    Time frame: after 12 weeks and 24 weeks

  2. Change in FPG (glucose variability)

    Time frame: after 12 weeks and 24 weeks

  3. Change in PPG (postprandial control)

    Time frame: after 12 weeks and 24 weeks

  4. Change in insulin dose and number of injections

    Time frame: after 12 weeks and 24 weeks

  5. Change in oral antidiabetic drug therapy

    Time frame: after 12 weeks and 24 weeks

  6. Change in body weight

    Time frame: after 12 weeks and 24 weeks

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

    Time frame: after 12 weeks and 24 weeks

  8. Number of adverse drug reactions (ADR)

    Time frame: after 12 weeks and 24 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart) or Levemir® (Insulin Detemir) - for Treatment of Diabetes Mellitus

Acronym: COMMIT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 13, 2008
Registry last updated
Oct 31, 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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