Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30; Drug: insulin detemir

• Registration Number: NCT00671008
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe.

The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-04-30
• Study First Posted: 2008-05-02
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients with Type 1 or Type 2 diabetes, including newly diagnosed
• Age: Levemir® above 6 years
• Age: Novomix® above 18 years

Exclusion Criteria

• Current treatment with NovoMix® 30 or Levemir®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Glycaemic control as measured by HbA1c	After 24 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects to reach HbA1c below 7.0% and =6.5%	After 24 weeks
Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30	After 24 weeks
The effect on glycamic control as measured by FPG	After 24 weeks
The effect on glycamic control as measured by PG profile	After 24 weeks
Change in body weight	After 24 weeks