An Observational Study in Type 2 Diabetic Patients on Oral Antidiabetic Drugs and Basal Insulin in Near East Countries

Completed

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

• Registration Number: NCT00842192
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Study Start: 2009-04
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2155

Inclusion Criteria

• After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes who is treated with any one or more of the oral antidiabetic drug (metformin, SU, repaglinide, TZDs) is eligible for the study. The selection of the subjects will be at the discretion of the individual physician. Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria

• Subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin
• 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 6 months. Women of childbearing potential who are not using adequate contraceptive methods

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Change in number of hypoglycaemic events from baseline	at 12 and 24 weeks
HbA1c	at 12 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Glucose variability as measured by FPG	at 12 and 24 weeks
Number of adverse drug reactions (ADR)	at 12 and 24 weeks
Postprandial glycaemic control as measured by PPG	at 12 and 24 weeks
Insulin dose and number of injections	at 12 and 24 weeks
Body weight	at 12 and 24 weeks
Percentage of subjects to reach HbA1c between 6.5 and 7.0%	at 12 and 24 weeks

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇰 Karachi, Pakistan