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

NCT04218734 | Completed Phase 3

• 1 other identifier: CSPC/DBPR108201903/PRO-III-2
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

DBPR108; Dipeptidyl peptidase-4 (DPP4) inhibitors; metformin hydrochloride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percentage of HbA1c ≤ 6.5%

  24 weeks

• Percentage of HbA1c ≤ 7%

  24 weeks

• Change in HbA1c (%) from baseline to week 12

  baseline, 12 weeks

• Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24

  Baseline, 12 weeks and 24 weeks

• Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24

  Baseline, 12 weeks and 24 weeks

Study Arms (2)

metformin hydrochloride+DBPR108

EXPERIMENTAL

metformin hydrochloride 500 mg+DBPR108 100 mg

Drug: DBPR108; Drug: metformin hydrochloride

metformin hydrochloride+placepo

PLACEBO COMPARATOR

metformin hydrochloride 500 mg+placebo 100 mg

Drug: metformin hydrochloride; Drug: placepo

Interventions

DBPR108 DRUG

DBPR108: 100 mg, once daily for 24 weeks.

metformin hydrochloride+DBPR108

metformin hydrochloride DRUG

metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks.

metformin hydrochloride+DBPR108; metformin hydrochloride+placepo

placepo DRUG

placebo:100 mg, once daily for 24 weeks.

metformin hydrochloride+placepo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

DBPR108; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Kun Lou

  Department of medicine, CSPC clinical development division

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 6, 2020
• Study Start: January 14, 2020
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-03

Locations

CN (1)