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The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin

NCT05505994 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2024-04-04

No results posted yet for this study

Summary

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Conditions

  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Glucose Metabolism Disorders
  • Metabolic Disease
  • Endocrine System Diseases

Interventions

DRUG

DWP16001

DWP16001 A mg tablet

DRUG

Dapagliflozin

Dapagliflozin tablet

DRUG

DWP16001 Placebo

DWP16001 Placebo tablet

DRUG

Dapagliflozin Placebo

Dapagliflozin Placebo tablet

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Principal Investigators

  • Linong Ji, Dr. · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-09-28
Primary Completion
2024-02-26
Completion
2024-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT05505994 on ClinicalTrials.gov