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

Completed

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

• Registration Number: NCT00665093
• 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: 2007-05
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1569

Inclusion Criteria

• Levemir® above 6 yrs
• NovoMix® 30 above 18 yrs
• Patients with Type 1 or Type 2 diabetes, including newly diagnosed

Exclusion Criteria

• Current treatment with NovoMix® 30 or Levemir®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HbA1c	at 24 weeks

Secondary Outcome Measures

Name	Time	Method
FPG, PG profile, weight, % of subjects on target	at 24 weeks

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇲🇰 Skopje, Macedonia, The Former Yugoslav Republic of