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Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Registration Number
NCT00568984
Lead Sponsor
Novo Nordisk A/S
Brief Summary

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
324
Inclusion Criteria
  • Type 2 diabetes for at least 3 months
  • No previous treatment for diabetes
  • HbA1c between 7.0-12.0%
  • Body Mass Index (BMI) between 19.0-40.0 kg/m2
Exclusion Criteria
  • Type 1 diabetes
  • Known unstable/untreated proliferative retinopathy
  • Uncontrolled treated/untreated hypertension
  • Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
HbA1cafter 16 weeks of treatment
Secondary Outcome Measures
NameTimeMethod
Glucose profiles
Quality of life assessment
Treatment satisfaction
Hypoglycaemic events
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site

🇹🇭

Bangkok, Thailand

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