Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes

Completed

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

• Registration Number: NCT00825643
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe, North America and Asia. The aim of this observational study is to evaluate the safety and effectiveness while using Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice.

Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and reported together in the final study report for this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18481

Inclusion Criteria

• After the participating physician's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate

Exclusion Criteria

• Current treatment with insulin
• Known or suspected allergy to Levemir® or excipients
• Children below the age of 6 years
• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin detemir	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia	during 24 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
HbA1c and its change from trial start	at the 12 and 24 week visits
Incidence of major and minor hypoglycaemic events	in the 4 weeks preceding trial start, and at the 12 and 24 week visits
Body weight and its change from trial start	at the 12 and 24 week visits
Incidence of all adverse drug reactions (ADRs)	during 24 weeks of treatment
FBG variability (measured as standard deviation of FBG) and its change from trial start	at the 12 and 24 weeks visits
Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start	at the 12 and 24 week visits

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇷 Istanbul, Turkey