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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670722
• Other study ID #: NN304-3517
• Status: Completed
• Phase: N/A
• First received: April 30, 2008
• Last updated: October 27, 2016
• Start date: January 2008
• Est. completion date: December 2009

Study information

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

Clinical Trial Summary

This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6500
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• Current treatment with human soluble insulin, insulin NPH or premixed human insulin

• The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

• Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30

• Previous enrolment in this study

• Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.

• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin aspart
Intervention at the discretion of the physician
• insulin detemir
Intervention at the discretion of the physician
• biphasic insulin aspart 30
Intervention at the discretion of the physician

Locations

Country	Name	City	State
Czech Republic	Novo Nordisk Investigational Site	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c after switch from human insulin to modern insulin treatment		After 24 weeks	No
Secondary	Percentage of subjects to reach HbA1c below 7.0% and = 6.5% at approximately 12 weeks and 24 weeks of treatment		After 12 and 24 weeks	No
Secondary	Postprandial glycaemic control as measured by PPG		After 12 and 24 weeks	No
Secondary	Glucose variability as measured by FPG		After 12 and 24 weeks	No
Secondary	Insulin dose and number of injections		After 12 and 24 weeks	No
Secondary	Body weight		After 12 and 24 weeks	No
Secondary	Number of hypoglycaemic events		During treatment	Yes
Secondary	Number of adverse drug reactions (ADR)		After 12 and 24 weeks	Yes

External Links

•   Clinical Trials at Novo Nordisk