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

October 27, 2016 updated by: Novo Nordisk A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3809

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Bratislava, Slovakia, 811 05
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetes type 2

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metabolic control measured as HbA1c
Time Frame: for the duration of the study
for the duration of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in body weight
Time Frame: after 12 weeks and 24 weeks
after 12 weeks and 24 weeks
Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5%
Time Frame: after 12 weeks and 24 weeks
after 12 weeks and 24 weeks
Change in FPG (glucose variability)
Time Frame: after 12 weeks and 24 weeks
after 12 weeks and 24 weeks
Change in PPG (postprandial control)
Time Frame: after 12 weeks and 24 weeks
after 12 weeks and 24 weeks
Change in insulin dose and number of injections
Time Frame: after 12 weeks and 24 weeks
after 12 weeks and 24 weeks
Change in oral antidiabetic drug therapy
Time Frame: after 12 weeks and 24 weeks
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
after 12 weeks and 24 weeks
Number of adverse drug reactions (ADR)
Time Frame: after 12 weeks and 24 weeks
after 12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-3516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on biphasic insulin aspart 30

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe