Type 2 diabetes mellitus
Conditions
Interventions
Control group:Metformin Dose Escalation
Experimental group:Cofrogliptin treatment
Sponsors
Xi'an Jiaotong University Second Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Diagnosed with Type 2 Diabetes Mellitus (T2DM) comorbid with Non-Alcoholic Fatty Liver Disease (NAFLD) according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020 Edition); HbA1c level between 6.5% and 10%; with inadequate glycemic control despite stable monotherapy with metformin (250-1000 mg/day); 3.Body Mass Index (BMI) between 20 and 35 kg/m^2, and stable body weight (weight change <= 10% over the past at least 3 months); 4.Voluntarily agrees to receive the study treatment and is willing to cooperate with follow-up; 5.No communication barriers; 6.Able to understand and voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Patients with other types of diabetes; 2.Alcohol intake > 30 grams/day (equivalent to 3 drinks per day) in the past 10 years or > 10 grams/day in the past year; evidence of other forms of liver disease, including autoimmune liver disease or viral hepatitis; 3.Initiation or change in anti-diabetic medication within 90 days, including the use of any glucose-lowering agents other than metformin within 3 months prior to screening, or use of other medications associated with hepatic steatosis, including but not limited to corticosteroids, tamoxifen, amiodarone, or methotrexate; 4.History of acute pancreatitis within the past 5 years (except for gallstone-induced pancreatitis); 5.Pregnant or lactating women, or women planning to become pregnant during the study period; 6.Severe renal impairment or renal failure, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 or undergoing dialysis; 7.Severe cardiac or cerebrovascular disease; severe pancreatic, hematological, or other systemic diseases; history of gastrointestinal resection; presence of proliferative diabetic retinopathy or malignancy; 8.History of allergy or hypersensitivity to DPP-4 inhibitors; or participation in another clinical study; 9.Patients with impaired consciousness, or audio/visual disorder, or any other condition deemed by the investigator as unsuitable for participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin,HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| NAFLD Fibrosis Score;The incidence of adverse reactions;Other liver indicators;Blood sugar control level; | — |
Countries
China
Contacts
Public ContactChunhong Zhang
Xi'an Jiaotong University Second Affiliated Hospital
Outcome results
None listed