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

Diabetes Mellitus, Type 2 Clinical Trial

— COMMIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676741
• Other study ID #: BIASP-3516
• Status: Completed
• Phase: N/A
• First received: May 9, 2008
• Last updated: October 27, 2016
• Start date: February 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3809
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Locations

Country	Name	City	State
Slovakia	Novo Nordisk Investigational Site	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic control measured as HbA1c		for the duration of the study	No
Secondary	Percentage of subjects achieving HbA1c below 7.0% and below or equal 6.5%		after 12 weeks and 24 weeks	No
Secondary	Change in FPG (glucose variability)		after 12 weeks and 24 weeks	No
Secondary	Change in PPG (postprandial control)		after 12 weeks and 24 weeks	No
Secondary	Change in insulin dose and number of injections		after 12 weeks and 24 weeks	No
Secondary	Change in oral antidiabetic drug therapy		after 12 weeks and 24 weeks	No
Secondary	Change in body weight		after 12 weeks and 24 weeks	No
Secondary	Change in number of hypoglycaemic events during 4 weeks proceeding routine visits		after 12 weeks and 24 weeks	Yes
Secondary	Number of adverse drug reactions (ADR)		after 12 weeks and 24 weeks	Yes

External Links

•   Clinical Trials at Novo Nordisk