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

Diabetes Mellitus, Type II Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04667143
• Other study ID #: SHR3824-SP2086-MET-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2021
• Est. completion date: October 2022

Study information

• Verified date: December 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 760
• Est. completion date: October 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• Retagliptin, Henagliflozein, metformin XR
Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in HbA1c at Week 24	• To compare the mean change from baseline in HbA1c achieved with concurrent addition of Retagliptin Plus Henagliflozein to metformin vs the addition of Retagliptin or Henagliflozein to metformin after 24 weeks of double-blind treatment.	24 weeks