Type 2 Diabetes Mellitus
Conditions
Interventions
experimental group:Phase A (Weeks 1-24): DBPR108 100mg and placebo matching Sitagliptin 100 mg
Phase B (Weeks 25-52): DBPR108 100 mg
Active Comparator:Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg and Sitagliptin 100 mg
Placebo Comparator:Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg and placebo matching Sitagliptin 100 mg
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subjects who meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes; 2) Male or female, aged >= 18 years to = 19kg/m^2 to = 7.0% to <= 9.5%; 6) Subjects voluntarily participate in the trial and sign the informed consent form; 7) Subjects agree to use effective methods of contraception from the signing of the informed consent form to the end of 1 month after the last dose.
Exclusion criteria
Exclusion criteria: 1) FPG > 13.9 mmol/L; 2) Subjects who are believed that they required insulin therapy by the investigator; 3) Acute complications of diabetes mellitus (including diabetic ketosis and ketoacidosis, hypertonic nonketoacid diabetic coma, lactic acidosis and hypoglycemic coma); 4) A history of severe hypoglycemia (that is, hypoglycemia with severe cognitive impairment and requiring other measures to help recover); 5) Subjects with severe diabetic complications (such as diabetic foot, etc.); 6) A history of acute or chronic pancreatitis, or a history of related diseases prone to the onset of acute pancreatitis (such as recurrent cholelithiasis, etc.); 7) Subjects with a history of allergy to similar drugs (DPP-4 inhibitors) or who are judged by the investigator to be potentially allergic to the tested drugs; 8) Uncured hyperthyroidism or other diseases may cause secondary blood sugar elevation; 9) Glucocorticoids (except for external use and inhalation) has been given continuously within 4 weeks prior to screening or may be given during the trial for >= 14 days; 10) Inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease associated with obvious digestive or absorption disorders; 11) AST or ALT > 3 times of the normal upper limit, or the total bilirubin > 1. 5 times of the normal upper limit; 12) Subjects with abnormal renal function: serum creatinine > 1.5 times the upper limit of normal value, or eGFR 5.7mmol/l; 14) In the absence of pacemaker, a 12-lead ECG shows degree II or III atrioventricular block, long QT syndrome or QTc > 500 ms; 15) Subjects with infectious diseases(all positive for HBsAg, HBeAg, HBcAb, or positive for hepatitis C antibody, or positive for anti-HIV antibody); 16) Female subjects of childbearing age are positive in pregnancy test or lactating women; 17) Subjects with a history of alcoholism or drug abuse; 18) Subjects who are participating in other clinical trials or who have participated in other drug trials within 3 months prior to screening; 19) Subjects have the following clinically significant unstable diseases: 1.Severe ventricular arrhythmias, obvious left ventricular dysfunction, cardiac function score NYHA III/IV, 2.A history of unstable angina pectoris, acute coronary syndrome and other high-risk coronary heart disease, 3.The blood pressure was still poorly controlled after taking antihypertensive drugs(the blood pressure continued at systolic blood pressure = 160mmHg or diastolic blood pressure = 100mm mg. 4.Subjects with cancer, or organ transplant, 5.A history of epileptic disease, or a history of mental illness, or severe depression, etc. 20) Not suitable for this clinical trial judged by the investigator.
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;Physical examination;Vital signs;Electrocardiogram; | — |
Countries
China
Contacts
Public ContactKun Lou
Outcome results
None listed