Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin (COMMIT)
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00676741
First received: May 9, 2008
Last updated: June 5, 2012
Last verified: June 2012
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Purpose
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 | Intervention |
|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: insulin aspart Drug: biphasic insulin aspart 30 Drug: insulin detemir |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Metabolic control measured as HbA1c [ Time Frame: for the duration of the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5% [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Change in FPG (glucose variability) [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Change in PPG (postprandial control) [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Change in insulin dose and number of injections [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Change in oral antidiabetic drug therapy [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Change in body weight [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Change in number of hypoglycaemic events during 4 weeks proceeding routine visits [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]
- Number of adverse drug reactions (ADR) [ Time Frame: after 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 3809 |
| Study Start Date: | February 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676741
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676741
Locations
| Slovakia | |
| Bratislava, Slovakia, 811 05 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Jozef Lacka, M.D. CSc. | Novo Nordisk Slovakia, s.r.o |
More Information
Additional Information:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00676741 History of Changes |
| Other Study ID Numbers: | BIASP-3516 |
| Study First Received: | May 9, 2008 |
| Last Updated: | June 5, 2012 |
| Health Authority: | Slovakia: State Institute for Drug Control |
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 Insulin, Isophane Biphasic Insulins Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016