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

Launched by CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY CO., LTD. · Jan 3, 2020

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.