Type 2 Diabetes Mellitus
Conditions
Keywords
DBPR108, Dipeptidyl peptidase-4 (DPP4) inhibitors, metformin hydrochloride
Brief 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.
Interventions
DRUGDBPR108
DBPR108: 100 mg, once daily for 24 weeks.
DRUGmetformin hydrochloride
metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks.
DRUGplacepo
placebo:100 mg, once daily for 24 weeks.
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (%) from baseline to week 24 | baseline, 24 weeks | The change of HbA1c from baseline to 24 weeks compared with metformin hydrochloride + placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of HbA1c ≤ 7% | 24 weeks | Proportion of patients achieving HbA1c ≤ 7% at week 24 |
| Change in HbA1c (%) from baseline to week 12 | baseline, 12 weeks | The change of HbA1c from baseline to 12 weeks compared with metformin hydrochloride + placebo |
| Percentage of HbA1c ≤ 6.5% | 24 weeks | Proportion of patients achieving HbA1c ≤ 6.5% at week 24 |
| Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24 | Baseline, 12 weeks and 24 weeks | The change in 2h-PPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo |
| Change in body weight from baseline to week 12 and week 24 | Baseline, 12 weeks and 24 weeks | The change in body weight from baseline to week 12 and week 24 compared with metformin hydrochloride +placebo |
| Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24 | Baseline, 12 weeks and 24 weeks | The change in FPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo |
Countries
China
Outcome results
None listed