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

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Diabetes Mellitus, Type II

Treatments: Drug: Retagliptin, Henagliflozein, metformin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT04667143

SHR3824-SP2086-MET-301

Details and patient eligibility

About

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

Enrollment: 760 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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. 19.0<BMI ≤ 40.0 kg/m2 at the screening visit;

Exclusion 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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760 participants in 5 patient groups

Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR

Experimental group

Treatment:

Drug: Retagliptin, Henagliflozein, metformin XR

Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR

Experimental group

Treatment:

Drug: Retagliptin, Henagliflozein, metformin XR

Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR

Experimental group

Treatment:

Drug: Retagliptin, Henagliflozein, metformin XR

Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR

Experimental group

Treatment:

Drug: Retagliptin, Henagliflozein, metformin XR

Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR

Experimental group

Treatment:

Drug: Retagliptin, Henagliflozein, metformin XR