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ACTIVE NOT RECRUITING
NCT05505994
PHASE3

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

Sponsor: Daewoong Pharmaceutical Co. LTD.

View on ClinicalTrials.gov

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.

Official title: A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of DWP16001 Add-on to Metformin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2022-09-28

Completion Date

2024-09

Last Updated

2024-04-04

Healthy Volunteers

No

Interventions

DRUG

DWP16001

DWP16001 A mg tablet

DRUG

Dapagliflozin

Dapagliflozin tablet

DRUG

DWP16001 Placebo

DWP16001 Placebo tablet

DRUG

Dapagliflozin Placebo

Dapagliflozin Placebo tablet

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China