A Multicentre, Open Label, Observational 24-week Study to Evaluate Safety of Initiating Insulin Therapy With Levemir® (Insulin Detemir) Once-daily in Oral Antidiabetic Drug-treated Patients With Type 2 Diabetes

Novo Nordisk A/S1 site in 1 country18,481 target enrollmentApril 2008

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin detemir

Drugsinsulin detemir

Overview

Phase: Not Applicable
Intervention: insulin detemir
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 18481
Locations: 1
Primary Endpoint: Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

March 2011

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

Insulin detemir

Intervention: insulin detemir

Outcomes

Primary Outcomes

Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia

Time Frame: during 24 weeks of treatment

Secondary Outcomes

HbA1c 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)
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)
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)