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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: DBPR108; Drug: metformin hydrochloride; Drug: placepo

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: metformin hydrochloride+DBPR108; metformin hydrochloride 500 mg+DBPR108 100 mg	Drug: DBPR108; DBPR108: 100 mg, once daily for 24 weeks.; Drug: metformin hydrochloride; metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks.
Placebo Comparator: metformin hydrochloride+placepo; metformin hydrochloride 500 mg+placebo 100 mg	Drug: metformin hydrochloride; metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks.; Drug: placepo; placebo:100 mg, once daily for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c (%) from baseline to week 24	The change of HbA1c from baseline to 24 weeks compared with metformin hydrochloride + placebo	baseline, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of HbA1c ≤ 6.5%	Proportion of patients achieving HbA1c ≤ 6.5% at week 24	24 weeks
Percentage of HbA1c ≤ 7%	Proportion of patients achieving HbA1c ≤ 7% at week 24	24 weeks
Change in HbA1c (%) from baseline to week 12	The change of HbA1c from baseline to 12 weeks compared with metformin hydrochloride + placebo	baseline, 12 weeks
Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24	The change in FPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo	Baseline, 12 weeks and 24 weeks
Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24	The change in 2h-PPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo	Baseline, 12 weeks and 24 weeks
Change in body weight from baseline to week 12 and week 24	The change in body weight from baseline to week 12 and week 24 compared with metformin hydrochloride +placebo	Baseline, 12 weeks and 24 weeks

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2020
• Primary Completion (Actual): June 3, 2021
• Study Completion (Actual): June 3, 2021

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: DBPR108; Dipeptidyl peptidase-4 (DPP4) inhibitors; metformin hydrochloride
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: CSPC/DBPR108201903/PRO-III-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No