An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: biphasic insulin aspart 30; Drug: insulin detemir; Drug: insulin aspart

• Registration Number: NCT00698269
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5926

Inclusion Criteria

• Type 1 or type 2 diabetes
• Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
• Selection will be at the discretion of the individual physician

Exclusion Criteria

• Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
• Previous enrolled in this study
• Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	biphasic insulin aspart 30	-
A	insulin detemir	-
C	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	during 24 weeks of treatment
Incidence of major hypoglycaemic events reported	during 24 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Change in PPG	at 12 & 24 weeks
Body weight	at 12 & 24 weeks
Change in number of hypoglycaemic events in the last 4 weeks before routine visits	at 12 & 24 weeks
Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits	at 12 & 24 weeks
Percentage of subjects achieving HbA1c below 7.0%	at 12 & 24 weeks
Change in FPG	at 12 & 24 weeks
Number of adverse drug reactions (ADR)	at 12 & 24 weeks

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇦 Riyadh, Saudi Arabia