A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM

• Status: Completed
• Trial end date: 2021-06-03
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108 or metformin hydrochloride plus placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Diagnosis of type 2 diabetes according to World Health Organization (1999) diabetes diagnosis standard;

• Age 18-75 years, men and women;

• BMI 19-35 kg/m2;

• HbA1c 7.0%-9.5%;

• Before screening, a stable Metformin dose（≥1000mg/day）should be maintained for at least 8 weeks.

• Signed informed consent from the patient;

• Agree to use contraceptive measures from the date of signing the informed consent to 1 month after the end of the last medication.

Exclusion Criteria:

• FPG > 13.9 mmol/L;

• Insulin treatment required in the investigator's opinion;

• Administration of antidiabetic drugs (except for metformin) including insulin, rosiglitazone, pioglitazone, DPP-4 inhibitor, Glucagon like peptide-1 (GLP-1) receptor agonist for 8 weeks before screening;

• Acute complications of diabetes (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);

• Severe hypoglycemia;

• Serious diabetic complications (such as diabetic foot, etc.);

• History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);

• History of being allergic to DPP-4 inhibitors;

• Untreated hyperthyroidism and other diseases which may cause secondary hyperglycemia;

• Previous treatment with glucocorticoids (except for external use and inhalation) within 4 weeks before screening or may be used for more than 14 consecutive days during the study;

• Inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders;

• Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 3*upper limit of normal (ULN), or total bilirubin > 1.5ULN;

• Abnormal renal function;

• White blood cells (WBC) < 3.0109/l, neutrophil count of peripheral blood < 1.5109/l, hemoglobin < 100g / L, triglyceride > 5.7 mmol/l;

• HBsAg, HBeAg or HBcAb positive, or any one of hepatitis C antibody, anti-HIV antibody and nonspecific antibody of Treponema pallidum positive;

• Pregnant or lactating women;

• History of alcohol or drug abuse;

• Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening;

• Significant unstable diseases;

• Any condition that in the investigator's opinion might render the patient unable to participate the trial.