CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 165 enrolled
Drug / intervention
Acarbose +2 moredrug
Likely dose
Acarbose 50mgfrom 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/NCT01490918
NCT01490918Phase 4Completed

A Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Acarbose Added on Top of Metformin and Sitagliptin Combination Treatment in Type 2 Diabetes Mellitus Patients

The Catholic University of Korea·interventional·Posted Dec 13, 2011·Updated Aug 17, 2020

In Brief

A Phase 4 clinical trial evaluating Acarbose, Placebo acarbose, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 165 participants across 1 site.

Detailed Summary

Primary objective To evaluate the efficacy of Acarbose add-on therapy on glucose control in subjects with type 2 diabetes inadequately controlled with Metformin and Sitagliptin combination therapy. The effect of acarbose, an alpha glucosidase inhibitor as a third-line therapeutic medication in subject who are inadequately controlled with metformin and DPP4 inhibitor will be evaluated with multicenter, randomized, 24-week, double blinded, placebo-controlled study in Korea.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
CollaboratorsBayer

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2011
Enrollment StartApr 1, 2012
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.6 years ago

Interventions

Acarbosedrug

Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid.

Placebo acarbosedrug

acarbose placebo

placebo metformindrug

metformin placebo