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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00676741

First Posted: May 13, 2008

Last Update Posted: October 31, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Novo Nordisk A/S

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:

Drug Information available for: Insulin Insulin human Insulin aspart Insulin detemir

U.S. FDA Resources

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 ]

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 ]
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 ]


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

Information from the National Library of Medicine

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

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

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

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 Submitted:	May 9, 2008
First Posted:	May 13, 2008
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

To Top