Observational Study of Safety and Efficacy of Levemir® in Type 2 Diabetes

Completed

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

• Registration Number: NCT00687063
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-30
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10008

Inclusion Criteria

• Any subject with type 2 diabetes

Exclusion Criteria

• Subjects with a hypersensitivity to insulin detemir or any of its excipient
• Children below 6 years
• Subjects who are pregnant, lactating or planning to become pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Weight change from baseline	after 26 weeks

Secondary Outcome Measures

Name	Time	Method
Insulin dose and frequency at the end of the study	after 26 weeks
FBG (Fasting Blood Glucose) change from baseline	after 26 weeks
Number of serious adverse events	after 26 weeks
Number of all hypoglycemic episodes (24 hr, daytime and nocturnal)	after 26 weeks
HbA1c change from baseline	after 26 weeks
Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 %	after 26 weeks
Number of all adverse events	after 26 weeks