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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30; Drug: insulin aspart; Drug: insulin detemir

• Registration Number: NCT00676741
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-05-09
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-13
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3809

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	biphasic insulin aspart 30	-
A	insulin aspart	-
C	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Metabolic control measured as HbA1c	for the duration of the study

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5%	after 12 weeks and 24 weeks
Change in FPG (glucose variability)	after 12 weeks and 24 weeks
Change in PPG (postprandial control)	after 12 weeks and 24 weeks
Change in insulin dose and number of injections	after 12 weeks and 24 weeks
Change in oral antidiabetic drug therapy	after 12 weeks and 24 weeks
Change in body weight	after 12 weeks and 24 weeks
Change in number of hypoglycaemic events during 4 weeks proceeding routine visits	after 12 weeks and 24 weeks
Number of adverse drug reactions (ADR)	after 12 weeks and 24 weeks

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇰 Bratislava, Slovakia