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An Add-on Study of MLR-1023 in Adults With Uncontrolled Type 2 Diabetes on Metformin Therapy

NCT03279263 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-01-09

No results posted yet for this study

Summary

This Phase 2, multi-center, double-blind, randomized, placebo-controlled, parallel group, add-on study of MLR 1023 in adults with uncontrolled T2DM on metformin anti diabetic monotherapy is designed to evaluate the efficacy and safety of MLR 1023 in combination with metformin in subjects with uncontrolled T2DM.

Conditions

Interventions

DRUG

MLR-1023

MLR-1023 Tablets

OTHER

Placebo

Matching Placebo Tablets

Sponsors & Collaborators

  • Bukwang Pharmaceutical, Co., Ltd.

    collaborator INDUSTRY

  • Melior Pharmaceuticals

    lead OTHER

Principal Investigators

  • Ramana Kuchibhatla, PhD · Melior Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03279263 on ClinicalTrials.gov