Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients

NCT01490918 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2020-08-17

Study results available
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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.

Conditions

Interventions

DRUG

Acarbose

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

DRUG

Placebo acarbose

acarbose placebo

DRUG

placebo metformin

metformin placebo

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY
  • The Catholic University of Korea

    lead OTHER

Principal Investigators

  • Kun-HO Yoon, professor · Seoul St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01490918 on ClinicalTrials.gov