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

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04667143

Collaborator

(none)

760

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type II	Drug: Retagliptin, Henagliflozein, metformin XR	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

760 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR	Drug: Retagliptin, Henagliflozein, metformin XR Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR
Experimental: Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR	Drug: Retagliptin, Henagliflozein, metformin XR Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR
Experimental: Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR	Drug: Retagliptin, Henagliflozein, metformin XR Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR
Experimental: Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR	Drug: Retagliptin, Henagliflozein, metformin XR Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR
Experimental: Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR	Drug: Retagliptin, Henagliflozein, metformin XR Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR

Outcome Measures

Primary Outcome Measures

Mean change from baseline in HbA1c at Week 24 [24 weeks]
• 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu HengRui Medicine Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04667143

Other Study ID Numbers:

SHR3824-SP2086-MET-301

First Posted:

Dec 14, 2020

Last Update Posted:

Dec 14, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Metformin

Study Results

No Results Posted as of Dec 14, 2020