Status:
UNKNOWN
Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Diabetes Mellitus, Type II
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
2 weeks screening period, 4 weeks run-in period, 24 weeks double-blind treatment period, to evaluate the Safety and Efficacy of Retagliptin Plus Henagliflozein added to Metformin compared to Retaglipt...
Eligibility Criteria
Inclusion
- Men and women, 18-75 years old (both inclusive) at time of screening visit;
- Subjects with T2DM with inadequate glycemic control defined as central laboratory HbA1c ≥ 7.5 and ≤ 10.5 % at the screening visit;
- FPG ≤ 15mmol/L at the screening visit;
- Stable metformin therapy for at least 8 weeks prior to screening at a dose ≥ 1500 mg per day;
- 19.0\<BMI ≤ 40.0 kg/m2 at the screening visit;
Exclusion
- Moderate or severe impairment of renal function \[defined as eGFR\<60mL/min/1.73 m2 (estimated by MDRD);
- Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg;
- Cardiovascular diseases within 6 months of the screening visit;
- ALT and/or AST \> 1.5 x ULN and or Total Bilirubin \> 1.2 x ULN;
- Hemoglobin ≤ 100 g/L;
- CK (creatine kinase) and CK-MB \> 3 x ULN;
- Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma);
- Administration of any antihyperglycemic therapy, other than metformin,within 2 months prior to screening;
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT04667143
Start Date
January 1 2021
End Date
October 1 2022
Last Update
December 14 2020
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