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

NCT04667143 | Unknown Phase 3

• 1 other identifier: SHR3824-SP2086-MET-301
• Study Type: interventional
• Target: 760
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR

EXPERIMENTAL

Drug: Retagliptin, Henagliflozein, metformin XR

Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR

EXPERIMENTAL

Drug: Retagliptin, Henagliflozein, metformin XR

Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR

EXPERIMENTAL

Drug: Retagliptin, Henagliflozein, metformin XR

Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR

EXPERIMENTAL

Drug: Retagliptin, Henagliflozein, metformin XR

Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR

EXPERIMENTAL

Drug: Retagliptin, Henagliflozein, metformin XR

Interventions

Retagliptin, Henagliflozein, metformin XR DRUG

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

Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR; Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR; Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR; Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR; Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \<BMI ≤ 40.0 kg/m2 at the screening visit;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 14, 2020
• Study Start: January 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 14, 2020

Record last verified: 2020-12