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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04667143

Enrollment

760

Registered

2020-12-14

Start date

2021-01-31

Completion date

2022-10-31

Last updated

2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type II

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

Interventions

DRUGRetagliptin, Henagliflozein, metformin XR

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026