Clinical trial NCT04218734: A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM
Official title: A Multicenter, Randomized, Double-blind, Parallel Controlled Phase III Clinical Trial of DBRP108 in Combination With Metformin Hydrochloride in the Treatment of Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: DBPR108
Dipeptidyl peptidase-4 (DPP4) inhibitors
metformin hydrochloride
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-06
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in HbA1c (%) from baseline to week 24
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: Percentage of HbA1c ≤ 6.5%
timeFrame: 24 weeks
measure: Percentage of HbA1c ≤ 7%
timeFrame: 24 weeks
measure: Change in HbA1c (%) from baseline to week 12
timeFrame: baseline, 12 weeks
measure: Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in body weight from baseline to week 12 and week 24
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Department of medicine, CSPC clinical development division
name: Kun Lou
role: STUDY_DIRECTOR
References: