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
|
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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 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 |
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
|
- Metabolic control measured as HbA1c [ Time Frame: for the duration of the study ]
- Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5% [ Time Frame: after 12 weeks and 24 weeks ]
- Change in FPG (glucose variability) [ Time Frame: after 12 weeks and 24 weeks ]
- Change in PPG (postprandial control) [ Time Frame: after 12 weeks and 24 weeks ]
- Change in insulin dose and number of injections [ Time Frame: after 12 weeks and 24 weeks ]
- Change in oral antidiabetic drug therapy [ Time Frame: after 12 weeks and 24 weeks ]
- Change in body weight [ Time Frame: after 12 weeks and 24 weeks ]
- Change in number of hypoglycaemic events during 4 weeks proceeding routine visits [ Time Frame: after 12 weeks and 24 weeks ]
- Number of adverse drug reactions (ADR) [ Time Frame: after 12 weeks and 24 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
Slovakia | |
Novo Nordisk Investigational Site | |
Bratislava, Slovakia, 811 05 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
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 |