Type 2 Diabetes
Conditions
Keywords
cofrogliptin, acarbose, type 2 diabetes
Brief summary
This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes
Detailed description
This study will enroll treatment-naïve patients with type 2 diabetes who meet inclusion criteria, and randomize them 1:1 to either the coglitin treatment group or the acarbose treatment group for a 12-week open-label parallel-controlled treatment period, with the coglitin group receiving 10mg coglitin tablets once every two weeks and the acarbose group receiving 50mg acarbose tablets three times daily; the primary endpoint is the change in glycated hemoglobin (HbA1c) from baseline at week 12, followed by a 1-week safety follow-up visit after treatment completion, with study conclusion upon completion of this safety visit.
Interventions
DRUGCofrogliptin
10mg administered once every two weeks
DRUGAcarbose
50mg administered 3 times daily
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1.Capable of understanding and voluntarily signing the written informed consent form. 2.Male or female aged ≥18 years (inclusive). 3.Fulfills diagnostic criteria for type 2 diabetes mellitus. 4.Previous glycemic control managed exclusively through diet and exercise therapy, with no prior exposure to any glucose-lowering or diabetes-related medications. 5.HbA1c at randomization: 7.0% ≤ HbA1c ≤ 9.0%. 6.Fasting plasma glucose (FPG) at randomization: FPG ≤ 11 mmol/L. 7.Body mass index (BMI) at randomization: 18 ≤ BMI ≤ 35 kg/m². 8.Agrees to maintain consistent dietary and exercise habits throughout the trial period.
Exclusion criteria
* 1.Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients. 2.History of diabetic ketoacidosis, type 1 diabetes, pancreatic/β-cell transplantation, or diabetes secondary to pancreatitis/pancreatectomy. 3.Acute coronary syndrome (STEMI/NSTEMI/unstable angina), stroke, or transient ischemic attack (TIA) within 3 months prior to informed consent. 4.Congestive heart failure (NYHA Class III-IV). 5.Uncontrolled hypertension (systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg). 6.Hepatic impairment: ALT, AST, or ALP \>3×ULN at screening. 7.Severe renal impairment (eGFR \<25 mL/min/1.73m²). 8.Chronic gastrointestinal disorders with significant malabsorption. 9.Conditions potentially aggravated by intestinal gas (e.g., Roemheld syndrome, severe hernia, intestinal obstruction/ulceration). 10.Bariatric surgery or malabsorptive gastrointestinal procedures within past 2 years. 11.Anti-obesity medications within 3 months prior to consent or weight instability at screening. 12.Malignancy (except basal cell carcinoma) within 5 years and/or active cancer therapy. 13.HIV infection. 14.Severe peripheral vascular disease. 15.Hematological disorders causing hemolysis/erythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia). 16.Current systemic corticosteroid use, thyroid hormone dose changes within 6 weeks, or uncontrolled endocrine disorders (excluding T2DM). 17.Substance abuse within 3 months or chronic conditions potentially compromising compliance. 18.Pregnancy, lactation, or unwillingness to use effective contraception (females/males). 19.Participation in other clinical trials within 30 days prior to screening. 20.Any other condition deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | From enrollment to the end of treatment at 12 weeks | The difference in HbA1c from the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2h-PPG (2-hour postprandial glucose) | From enrollment to the end of treatment at 12 weeks | The difference in 2h-PPG from the baseline |
| Fasting C-peptide | From enrollment to the end of treatment at 12 weeks | The difference in fasting C-peptide from the baseline |
| Insulin sensitivity | From enrollment to the end of treatment at 12 weeks | The difference in insulin sensitivity from the baseline |
| Islet function | From enrollment to the end of treatment at 12 weeks | The difference in Islet function from the baseline |
| FPG (Fasting plasma glucose) | From enrollment to the end of treatment at 12 weeks | The difference in FPG from the baseline |
| Intestinal microbial composition and functional characteristics | From enrollment to the end of treatment at 12 weeks | The difference in intestinal microbial composition and functional characteristics from the baseline |
| Incidence of hypoglycemia | From enrollment to the end of safety visitation at 13 weeks | The percentage of subjects who experienced any investigator-defined hypoglycemic adverse event |
| Gastrointestinal adverse events | From enrollment to the end of safety visitation at 13 weeks | The percentage of subjects who experienced any investigator-defined gastrointestinal adverse events adverse event |
| Other adverse events | From enrollment to the end of safety visitation at 13 weeks | The percentage of subjects who experienced any investigator-defined adverse event |
| Body weight | From enrollment to the end of treatment at 12 weeks | The difference in body weight from the baseline |
Countries
China
Contacts
Primary ContactFangqiong Li
Outcome results
None listed