diabetes
Conditions
Interventions
Experimental group:Cofrogliptin
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Be able to understand the procedures and methods of this experiment and voluntarily sign the ICF; 2. Newly diagnosed and untreated T2DM patients aged 18 to 75 years old (inclusive of 18 and 75 years old); 3. Before randomization, HbA1c conformance: 7.0%<=HbA1c<=8.5%; 4. The fasting blood glucose (FPG) before randomization was consistent: FPG < 9mmol/L; 5. The pre-random body mass index (BMI) meets: BMI < 25 kg/m2; 6. Agree to maintain the same diet and exercise habits throughout the trial, and be willing and able to correctly use fingertip blood glucose monitors and home blood glucose meters for self-monitoring of blood glucose (SMBG) and keep records.
Exclusion criteria
Exclusion criteria: 1. Other types of diabetes; 2. Diabetic ketoacidosis or hypertonic coma; 3. There is no significant organ damage, such as acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, unstable angina pectoris), stroke or transient ischemic attack (TIA) occurring within 3 months; Moderate or severe liver dysfunction caused by various reasons. Liver dysfunction is defined as the levels of ALT (alanine aminotransferase), AST (aspartate aminotransferase), or alkaline phosphatase measured during the screening period being higher than 3 ×ULN (the upper limit of normal). Moderate or above renal insufficiency caused by various reasons. 4. Within the past two weeks, the individual has suffered from diseases that may significantly affect drug absorption, distribution, metabolism and excretion, including: inflammatory bowel disease, peptic ulcer, history of gastrointestinal or rectal bleeding, history of major gastrointestinal surgeries (such as: gastrectomy, gastrointestinal anastomosis or intestinal resection), and has been judged by the investigator as unsuitable to participate in this study; 5. Drug-uncontrolled hypertension: Systolic blood pressure >=160mmHg or diastolic blood pressure >=90mmHg; 6. 3 months of having received anti-obesity drug treatment or any other treatment (such as surgery, aggressive diet plans, etc.) at the time of screening, resulting in unstable weight; 7. A history of cancer (excluding basal cell carcinoma) and/or cancer treatment within 7.5 years; 8. No active infection; 9. Various immune system diseases that require glucocorticoid treatment; 10. 3 Within the past three months, there has been any chronic disease caused by alcohol or drug abuse that may reduce trial compliance, or any chronic disease that the researcher believes may lead to reduced study compliance or reduced use of study drugs; 11. It is known that there is an allergy history to the components of the test drug or other drugs or excipients with similar chemical structures; 12. Women who are pregnant, preparing for pregnancy during research, or are breastfeeding; Women who were unwilling to take reliable contraceptive measures (including condoms, spermicides or intrauterine devices, etc.) from the date of signing the informed consent form to 28 days after the administration of the last investigational drug, or who planned to use progesterone-containing contraceptives during this period; Men who still have family planning during the research period; 13. Participated in any other clinical research within 30 days; 14. The researcher determines that there are other circumstances that are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The attainment rate of glycated hemoglobin (HbA1c) after 12 weeks of treatment (the proportion of patients with HbA1c<=7%).; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of fasting blood glucose (FPG), 1-hour postprandial blood glucose (1h-PPG), and 2-hour postprandial blood glucose (2h-PPG) relative to the baseline after 12 weeks of treatment;;Abnormal conditions in laboratory tests, incidence of adverse events, and hypoglycemic events;The changes in the Quality of Life Specific Scale (DSQL) score of Diabetic patients relative to the baseline period;The changes of insulin level and C-peptide level relative to the baseline after 12 weeks of treatment;The changes of fingertip self-monitoring of blood glucose (SMBG) indicators relative to the baseline after 4, 8, and 12 weeks of treatment;The compliance of the treatment method after 12 weeks of treatment; | — |
Countries
China
Contacts
Public ContactJin Lu
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed