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: NCT00670722
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-04-30
• Study First Posted: 2008-05-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HbA1c after switch from human insulin to modern insulin treatment	After 24 weeks

Secondary Outcome Measures

Name	Time	Method
Postprandial glycaemic control as measured by PPG	After 12 and 24 weeks
Glucose variability as measured by FPG	After 12 and 24 weeks
Insulin dose and number of injections	After 12 and 24 weeks
Number of adverse drug reactions (ADR)	After 12 and 24 weeks
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
Body weight	After 12 and 24 weeks
Number of hypoglycaemic events	During treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇿 Prague, Czech Republic