Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Phase 3

Completed

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

• Registration Number: NCT01709929
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2287

Inclusion Criteria

• Diagnosed with type 1 or type 2 diabetes
• Using a basal/bolus insulin regimen

Exclusion Criteria

• Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
• Subjects who previously enrolled in this study
• Subjects with a hypersensitivity to insulin detemir or to any of the excipients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin detemir	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events

Secondary Outcome Measures

Name	Time	Method
Number of all hypoglycaemic events
Number of adverse events (all and serious)
HbA1c (glycosylated haemoglobin)
Change in weight
Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)