Health TrialsbyHealthPanel

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

ConditionT2DM
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHuazhong University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Type 1 Diabetes Mellitus.

Any type of secondary diabetes.

Pending or having undergone pancreatic or β-cell transplantation.

History of pancreatitis or pancreatic resection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SGLT2i+Metformin+Cofrogliptin

    Drug

    The combination of SGLT2i+Metformin+Cofrogliptin

  • SGLT2i+Metformin+Linagliptin

    Drug

    The combination of SGLT2i+Metformin+Linagliptin

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Cofrogliptin Add-on GroupExperimental treatment 1 intervention
Group B: Linagliptin active-control GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
From enrollment to the end of treatment at 24 weeks

Secondary outcomes

1

HbA1c target rate

Proportion of subjects achieving HbA1c \< 7.0% and \< 6.5% at 24 weeks.

Time frame
From enrollment to the end of treatment at 24 weeks
2

2h-PPG and FPG

Changes in 2-hour postprandial plasma glucose (2h-PPG) and fasting plasma glucose (FPG) from baseline at 12 and 24 weeks.

Time frame
From enrollment to the end of treatment at 24 weeks
3

Change in HbA1c levels

Change in HbA1c levels from baseline at 24 weeks.

Time frame
From enrollment to the end of treatment at 24 weeks
4

Weight related items

Changes in body weight, fasting C-peptide, HOMA-IR, and HOMA-β from baseline at 24 weeks.

Time frame
From enrollment to the end of treatment at 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huazhong University of Science and Technology

Lead sponsor

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

Source ClinicalTrials.gov
Apply now