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

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ClinicalTrials.gov Identifier: NCT00676741
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin aspart Drug: biphasic insulin aspart 30 Drug: insulin detemir

Study Design
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Study Type : Observational
Actual Enrollment : 3809 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : February 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
A Drug: insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Name: NovoRapid®
B Drug: biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
C Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation


Outcome Measures
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Primary Outcome Measures :
  1. Metabolic control measured as HbA1c [ Time Frame: for the duration of the study ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetes type 2
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676741


Locations
Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 811 05
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00676741     History of Changes
Other Study ID Numbers: BIASP-3516
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
 Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs