Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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 Retagliptin or Henagliflozein in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Men and women, 18-75 years old (both inclusive) at time of screening visit;

2. Subjects with T2DM with inadequate glycemic control defined as central laboratory HbA1c ≥ 7.5 and ≤ 10.5 % at the screening visit;

3. FPG ≤ 15mmol/L at the screening visit;

4. Stable metformin therapy for at least 8 weeks prior to screening at a dose ≥ 1500 mg per day;

5. 19.0Exclusion Criteria:

1. Moderate or severe impairment of renal function [defined as eGFR<60mL/min/1.73 m2 (estimated by MDRD);

2. Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg;

3. Cardiovascular diseases within 6 months of the screening visit;

4. ALT and/or AST > 1.5 x ULN and or Total Bilirubin > 1.2 x ULN;

5. Hemoglobin ≤ 100 g/L;

6. CK (creatine kinase) and CK-MB > 3 x ULN;

7. Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma);

8. Administration of any antihyperglycemic therapy, other than metformin,within 2 months prior to screening;