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Clinical Study of Retagliptin Phosphate Combined With Metformin in the Treatment of Type 2 Diabetes

NCT05054842 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2023-07-10

No results posted yet for this study

Summary

Retagliptin phosphate tablet is a DPP IV inhibitor durg，study number is HR-SP2086-304. The primary purpose of the study is to evaluate the efficacy of the combination of Retagliptin phosphate and metformin compared with placebo and metformin in type 2 diabetes subjects with poor glycemic control treated with metformin for 16 weeks.

Conditions

Interventions

DRUG

Retagliptin phosphate tablets、metformin sustained-release tablets

Retagliptin phosphate tablets 100mg+ metformin sustained-release tablets 1500mg or 2000mg based on prior medication

DRUG

Retagliptin phosphate placebo tablets、metformin sustained-release tablets

Retagliptin phosphate 100mg placebo tablets + metformin sustained-release tablets 1500mg or 2000mg based on prior medication

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

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 NCT05054842 on ClinicalTrials.gov