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Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients

NCT03349684 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2020-08-05

No results posted yet for this study

Summary

To demonstrate the efficacy and safety of acarbose and metformin loose-dose combination as compared to metformin monotherapy in the treatment of subjects with T2DM that is inadequately controlled by metformin alone

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Acarbose

Uptitrated in the treatment phase from 50 mg per day for 1 week, followed by 100 mg per day for another week, and 150 mg per day for the rest 14 weeks, oral, with the first mouthful of main meal

DRUG

Metformin

500 mg 3 times daily, oral, with the first mouthful of main meal

DRUG

Placebo

Acarbose matching placebo, oral

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2019-08-12
Completion
2019-08-21

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03349684 on ClinicalTrials.gov