Back to resultsDual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy
Primary Purpose
Diabetes Mellitus, Type II
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Retagliptin, Henagliflozein, metformin XR
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type II
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR
Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR
Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR
Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR
Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04667143
First Posted
December 9, 2020
Last Updated
December 9, 2020
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04667143
Brief Title
Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
760 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR
Arm Type
Experimental
Arm Title
Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR
Arm Type
Experimental
Arm Title
Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR
Arm Type
Experimental
Arm Title
Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR
Arm Type
Experimental
Arm Title
Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Retagliptin, Henagliflozein, metformin XR
Intervention Description
Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR
Primary Outcome Measure Information:
Title
Mean change from baseline in HbA1c at Week 24
Description
• 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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
12. IPD Sharing Statement
Learn more about this trial
Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy
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