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

Completed

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

• Registration Number: NCT01542424
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate efficacy and safety of NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) in subjects with type 1 or 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-03-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1889

Inclusion Criteria

• Macedonian people with diabetes mellitus (Type 1 or Type 2)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIAsp 30 users	biphasic insulin aspart 30	-
IDet users	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose (FPG)
Percentage of subjects reaching HbA1c target of maximum 7.0%
Postprandial plasma glucose (PPG)
Change in body weight
Incidence of adverse events

Trial Locations

Locations (1)

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