CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 433 enrolled
Drug / intervention
repaglinide +2 moredrug
Likely dose
repaglinide 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00819741
NCT00819741Phase 4Completed

A 16-week, Open-label, Multicentre, Randomised, Parallel Study to Evaluate Efficacy and Safety of Repaglinide and Metformin Combination Therapy Compared to Repaglinide Monotherapy in Chinese OAD Naive Type 2 Diabetic Patients

Novo Nordisk A/S·interventional·Posted Jan 9, 2009·Updated Feb 10, 2017

In Brief

A Phase 4 clinical trial evaluating repaglinide and metformin for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 433 participants across 17 sites.

Detailed Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The associated unfavourable events including low blood sugar episodes between the two treatments are also compared.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 9, 2009
Enrollment StartFeb 1, 2009
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.5 years ago

Interventions

repaglinidedrug

The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily

metformindrug

The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily

repaglinidedrug

The dose was started from repaglinide 1 mg three times daily. During the dose titration period, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose.