Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

Completed

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

• Registration Number: NCT00842894
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Study Start: 2009-05
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-11
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3421

Inclusion Criteria

• After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria

• Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
• Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
• Subjects who were previously enrolled in this study
• Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biphasic insulin aspart 30	biphasic insulin aspart 30	-
Insulin detemir	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse drug reactions (SADRs)	after 26 weeks

Secondary Outcome Measures

Name	Time	Method
Number of all minor hypoglycaemic events	during 4 weeks preceding each visit
Number of all major hypoglycaemic events	during 13 weeks preceding each visit
HbA1c	after 26 weeks
Percentage of subjects to reach HbA1c below 7.0%	after 13 weeks and 26 weeks
The effect on glycaemic control as measured by FPG (fasting plasma glucose)	after 13 weeks and 26 weeks
The effect on glycamic control as measured by PG profile	after 13 weeks and 26 weeks
Change in body weight	after 13 weeks and 26 weeks