The Effect of Insulin Detemir on Blood Glucose Control in Taiwanese Patients With Type 2 Diabetes Failing on OAD

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00521690
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Study First Submitted: 2007-08-27
• Study First Submitted QC: 2007-08-27
• Study First Posted: 2007-08-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Type 2 diabetes
• HbA1C: 7.0-11.0%
• Previous diabetes treatment for at least 6 months
• BMI max. 35 kg/m2
• Treatment with an oral anti-diabetic drug (OAD)

Exclusion Criteria

• Type 1 diabetes
• Receipt of any investigational drug within the last three months prior to this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events, including major hypoglycaemic events	during 16 weeks of insulin detemir therapy

Secondary Outcome Measures

Name	Time	Method
Change in HbA1C	after 16 weeks
Change in weight
Incidence of hypoglycaemic episodes
Change in fasting plasma glucose (FPG)