Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00491725
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-26
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

• Type 2 diabetes for at least 12 weeks
• HbA1c: 8.0-10.0%
• Current treatment with OAD on monotheray or OAD on combination therapy
• Body mass index (BMI): 21.0-35.0 kg/m2

Exclusion Criteria

• Known or suspected allergy to trial product(s) or related products
• Recurrent major hypoglycaemia as judged by the Investigator
• Uncontrolled hypertension
• Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HbA1c	after 18 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Safety profile
Post Prandial Plasma Glucose
Fasting Plasma Glucose (FPG)