Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus

Completed

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

• Registration Number: NCT00709475
• 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 serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-30
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-03
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 747

Inclusion Criteria

• After the physician decision has been made to use 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. The selection of the subjects will be at the discretion of the individual physician

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 insulin detemir;
• Subjects who previously enrolled in this study or studies related to NovoMix 30;
• Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.

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, evaluated via number of major hypoglycaemic events	For the duration of the study (32 weeks)

Secondary Outcome Measures

Name	Time	Method
Number of serious adverse events	For the duration of the study
Fasting glucose level control compared to baseline as measured by FBG	After 16 and 32 weeks of treatment
HbA1c compared to baseline	At the end of the study
Number of all - daytime and nocturnal - hypoglycaemic events	In the 4 weeks before baseline compared to 4 weeks before interim and final visits
Weight changes compared to baseline	At the end of the study
Number of all adverse events	For the duration of the study

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇦 Riyadh, Saudi Arabia