Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.

NCT07019012 | Recruiting Phase 4 DMC

• 1 other identifier: HSK7653-501
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to 24 weeks after the combination therapy of cofrogliptin, metformin and SGLT2i (dapagliflozin) in type 2 diabetes mellitus (T2DM) patients with poor control of glucose level by metformin and SGLT2i combination therapy.

Conditions

T2DM

Outcome Measures

Primary Outcomes (1)

• The change in glycated hemoglobin (HbA1c) levels

  To evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to week 24 after triple combination therapy with cofrogliptin added to metformin and sodium-glucose cotransporter 2 inhibitor(SGLT2i) in type 2 diabetes mellitus (T2DM) patients who have inadequately controlled blood glucose despite adequate metformin and SGLT2i therapy.

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (4)

• HbA1c target rate

  From enrollment to the end of treatment at 24 weeks

• 2h-PPG and FPG

  From enrollment to the end of treatment at 24 weeks

• Change in HbA1c levels

  From enrollment to the end of treatment at 24 weeks

• Weight related items

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Cofrogliptin Add-on Group

EXPERIMENTAL

Triple combination therapy with cofrogliptin added to metformin and SGLT2i in type 2 diabetes mellitus (T2DM) patients who have inadequately controlled blood glucose despite adequate metformin and SGLT2i therapy for at least 12 weeks.

Drug: SGLT2i+Metformin+Cofrogliptin

Linagliptin active-control Group

ACTIVE COMPARATOR

Triple combination therapy with linagliptin as active-control drug added to metformin and SGLT2i in type 2 diabetes mellitus (T2DM) patients who have inadequately controlled blood glucose despite adequate metformin and SGLT2i therapy for at least 12 weeks.

Drug: SGLT2i+Metformin+Linagliptin

Interventions

SGLT2i+Metformin+Cofrogliptin DRUG

The combination of SGLT2i+Metformin+Cofrogliptin

Cofrogliptin Add-on Group

SGLT2i+Metformin+Linagliptin DRUG

The combination of SGLT2i+Metformin+Linagliptin

Linagliptin active-control Group

Eligibility Criteria

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

You may qualify if:

• Able to understand and voluntarily sign a written informed consent form.
• Male or female subjects aged 18 years and above .
• Meet the diagnostic criteria for Type 2 Diabetes Mellitus (T2DM).
• Have been on initial SGLT2i monotherapy (dapagliflozin) at a dose of 10 mg daily for at least 12 weeks.
• Have received metformin treatment for ≥12 weeks, with a stable dose maintained during the screening period (≥1500 mg/day if tolerable or at the maximum tolerated dose (\<1500 mg/day but ≥1000 mg/day), and no dosage adjustment).
• HbA1c levels within the range: 7.0% \< HbA1c ≤ 10.0%.
• Fasting plasma glucose (FPG) \< 15 mmol/L.
• Body Mass Index (BMI) ≤ 40 kg/m2.
• Estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml/min/1.73m2.
• Agree to maintain the same diet and exercise habits throughout the trial period, willing and able to accurately use a home blood glucose meter for self-monitoring of blood glucose (SMBG) and keep records.

You may not qualify if:

• Type 1 Diabetes Mellitus.
• Any type of secondary diabetes.
• Pending or having undergone pancreatic or β-cell transplantation.
• History of pancreatitis or pancreatic resection.
• Complicated with diabetic ketoacidosis or hyperosmolar coma.
• Moderate or severe hepatic insufficiency of any cause. Hepatic insufficiency is defined as screening period levels of ALT (SGPT), AST (SGOT), or alkaline phosphatase serum levels exceeding 3 times the upper limit of normal (ULN).
• Acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina), stroke, or transient ischemic attack (TIA) within the last 3 months.
• Uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
• Hemoglobin levels \< 10 g/l or 100 mg/dl.
• More than 2 recurrent genitourinary infections within the last 3 months.
• History of bariatric surgery or other gastrointestinal surgeries leading to chronic malabsorption within the last 2 years.
• Weight instability due to anti-obesity medication within the last 3 months or any other treatment (such as surgery, aggressive diet plans) at screening.
• History of cancer (excluding basal cell carcinoma) and/or cancer treatment within the last 5 years.
• Human Immunodeficiency Virus (HIV) infection.
• Severe peripheral vascular disease.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Renmin Hospital of Wuhan University: collaborator
• Wuhan Central Hospital: collaborator
• Taihe Hospital: collaborator
• Xiangyang No.1 People's Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator

Study Sites (2)

Wuhan University People's Hospital

Wuhan, Hubei, China

RECRUITING

Wuhan University People's Hospital

Wuhan, Hubei, China

RECRUITING

Study Officials

• XueFeng Yu, Doctor

  Tongji Hosptial Affiliated to Tongji Medical College of Huazhong University fo Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZheLong Liu, Doctor

CONTACT

+86 139 8623 5028; liuzhelong@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Endocrinology, Tongji Hosptial Affiliated to Tongji Medical College of Huazhong University fo Science and Technology

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: June 13, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)