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

NCT ID: NCT04667143

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Diabetes Mellitus, Type II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR

Group Type EXPERIMENTAL

Retagliptin, Henagliflozein, metformin XR

Intervention Type DRUG

Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR

Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR

Group Type EXPERIMENTAL

Retagliptin, Henagliflozein, metformin XR

Intervention Type DRUG

Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR

Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR

Group Type EXPERIMENTAL

Retagliptin, Henagliflozein, metformin XR

Intervention Type DRUG

Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR

Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR

Group Type EXPERIMENTAL

Retagliptin, Henagliflozein, metformin XR

Intervention Type DRUG

Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR

Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR

Group Type EXPERIMENTAL

Retagliptin, Henagliflozein, metformin XR

Intervention Type DRUG

Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR

Interventions

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Retagliptin, Henagliflozein, metformin XR

Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SHR3824-SP2086-MET-301

Identifier Type: -

Identifier Source: org_study_id