A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia

Novo Nordisk A/S0 sites3,421 target enrollmentMay 2009

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin detemir biphasic insulin aspart 30

Overview

Phase: Not Applicable
Intervention: insulin detemir
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 3421
Primary Endpoint: Incidence of serious adverse drug reactions (SADRs)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

October 2010

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Insulin detemir

Intervention: insulin detemir

Biphasic insulin aspart 30

Intervention: biphasic insulin aspart 30

Outcomes

Primary Outcomes

Incidence of serious adverse drug reactions (SADRs)

Time Frame: after 26 weeks

Secondary Outcomes

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)