Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin detemir

• Registration Number: NCT00700765
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1531

Inclusion Criteria

• Type 1 or type 2 diabetes mellitus

Exclusion Criteria

• Subjects who are unlikely to comply with the protocol
• Subjects who are currently being treated with Levemir®
• Subjects who previously were enrolled into the study
• Subjects with hypersensitivity to Levemir® or any of its excipients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse drug reactions (SADRs)	during treatment
Major hypoglycaemic events	during treatment

Secondary Outcome Measures

Name	Time	Method
HbA1c	after 12 weeks and 26 weeks of treatment
Number of all hypoglycaemic events	the last 4 weeks of treatment
Variability in fasting blood glucose (FBG) and average plasma glucose level	after 12 weeks
Number of all adverse events	during treatment
Weight changes	after 12 weeks
Number of serious adverse events	during treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇩 Jakarta, Indonesia