UnknownPhase 3

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

China174 participantsStarted 2021-12-06

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
✓. The screening age should be 18-75 years old (including both ends), male or female;
✓. Diagnosed with type 2 diabetes, 7.5%≤HbA1c≤11%;
✓. At least 8 weeks prior to screening, in addition to regular diet control and exercise, a steady dose of metformin ≥1500mg/d;
✓. Fasting glucose ≤13.3mmol/L; 6、19.0 \< BMI 35.0 kg/m2 or less.

Exclusion criteria

✕. General situation:
✕. History or evidence of any of the following diseases at the time of screening:
✕. Received any of the following pharmacological or non-pharmacological treatments or procedures prior to screening:
✕. Any of the laboratory test indicators during screening meet the following standards (those who meet the criteria can be retested once within one week if there is a clear reason for retesting) :
✕. Significant abnormal 12-lead electrocardiogram (ECG) results during screening, which the investigator considered might affect the safety of the subjects and are not suitable for this study;
✕. Any other conditions (such as affecting the safety or efficacy evaluation of the subjects) that the investigator deemed inappropriate for the subjects to participate in the study.

What they're measuring

Changes in HbA1c relative to baseline

Timeframe: After 16 weeks of treatment

Trial details

NCT IDNCT05054842

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Type 2 Diabetes trials