Type 2 Diabetes Mellitus
Conditions
Interventions
experimental group:Treatment period (1w-24w): DBPR108 tablets and metformin hydrochloride tablets
control group:Treatment period (1w-24w): DBPR108 placebo and metformin hydrochloride tablets
Sponsors
Beijing Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. According to who (1999) diabetes diagnosis standard (Appendix 2), subjects diagnosed as type 2 diabetes; 2. 18 = 1000mg / day was used before screening, and the fixed dose was used for more than 8 weeks; 6. Patients who voluntarily participated in the trial and signed the informed consent; 7. All subjects agreed to contraception for a period of 1 month from the signing of informed consent to the end of the last medication.
Exclusion criteria
Exclusion criteria: 1. FPG > 13.9mmol/L; 2. Subjects who the researchers think need insulin treatment; 3. In the first 8 weeks, subjects who had regularly used antidiabetic drugs, including insulin, rosiglitazone, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist and so on, except metformin were selected; 4. Patients with acute diabetic complications (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemic coma); 5. Patients who have a history of severe hypoglycemia (i.e. hypoglycemia with severe cognitive impairment and need other measures to help recover); 6. Subjects with severe diabetic complications (such as diabetic foot, etc.); 7. Patients with a history of acute or chronic pancreatitis, or a history of related diseases that are likely to cause the onset of acute pancreatitis (such as history of recurrent cholelithiasis, etc.); 8. Patients with a history of allergy to a similar drug (DPP-4 inhibitor) or patients who may be allergic to the test drug according to the judgment of the researcher; 9. Untreated hyperthyroidism and other diseases may cause secondary hyperglycemia; 10. Patients (except those for external use and inhalation) who may need glucocorticoids for more than 14 consecutive days within 4 weeks before screening or in the trial; 11. Subjects with inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders; 12. Patients with ast or ALT > 3 times of the upper limit of normal, or total bilirubin > 1.5 times of the upper limit of normal; 13. Subjects with abnormal renal function: blood creatinine > 1.5 times the upper limit of normal value; or EGFR 5.7mmol/l; 15. In the absence of pacemaker, 12 lead ECG showed degree II or degree III atrioventricular block, long QT syndrome or QTc > 500 ms; 16. Patients with positive HBsAg, HBeAg and HBcAb in infectious disease screening, or patients with positive hepatitis C antibody, anti HIV antibody and non-specific antibody of Treponema pallidum; 17. Women of childbearing age who have positive pregnancy test, or breast-feeding women; 18. Subjects with a history of alcohol or drug abuse; 19. Subjects who are participating in other clinical trials or who have used other test drugs or devices within 3 months before screening; 20. Subjects with the following clinically significant unstable diseases: Severe ventricular arrhythmia, obvious left ventricular dysfunction and NYHA III / IV; There were high risk coronary heart disease such as unstable angina and acute coronary syndrome; After taking antihypertensive drugs, the blood pressure was still under control, that is, the blood pressure was maintained at systolic pressure = 160mmhg or diastolic pressure = 100mmhg; Cancer history, organ transplant; Epilepsy history, mental history, severe depression, etc; 21. There are other factors that the researchers think are not suitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;2-hour postprandial blood glucose;Body weight;Blood routine;Blood chemistry;Urine routine;Vital signs;Physical examination;Electrocardiogram; | — |
Countries
China
Contacts
Public ContactKun Lou
Shijiazhuang Pharmaceutical Group Co., Ltd
Outcome results
None listed