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 A/S
ClinicalTrials.gov Identifier:
NCT00676741
First received: May 9, 2008
Last updated: June 5, 2012
Last verified: June 2012
  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
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

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:
No publications provided

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Globin Zinc
Insulin, Isophane
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014