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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00676741
First received: May 9, 2008
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676741

Locations
Slovakia
Bratislava, Slovakia, 811 05
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Jozef Lacka, M.D. CSc. Novo Nordisk Slovakia, s.r.o
  More Information

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

No publications provided

Responsible Party: Novo Nordisk
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 aspart
 Insulin
Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013