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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

324

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Nov 2002

Shorter than P25 for phase_4 diabetes

Geographic Reach

4 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

12 months study duration

Study Start

First participant enrolled

November 21, 2002

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2003

Completed

4.1 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed

Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

12 months

First QC Date

December 4, 2007

Last Update Submit

February 17, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c
after 16 weeks of treatment

Secondary Outcomes (5)

Glucose profiles
Quality of life assessment
Treatment satisfaction
Hypoglycaemic events
Adverse events

Interventions

repaglinideDRUG

metforminDRUG

glicazideDRUG

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.