A Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients

NCT05146869 | Completed Phase 1

• 1 other identifier: HA1118-014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose and multiple-dose of DBPR108 tablets in Type 2 Diabetes Mellitus Patients.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (7)

• Peak plasma concentration (Cmax) of DBPR108 tablets

  Cmax of DBPR108 tablets will be assessed after single-dose and multiple-dose administration

  Day 1-Day 11

• Area under the plasma concentration versus time curve (AUC) of DBPR108 tablets in plasma

  AUC of DBPR108 tablets will be assessed after single-dose and multiple-dose administration

  Day 1-Day 11

• Half-life(t1/2) of DBPR108 tablets

  T1/2 of DBPR108 tablets will be assessed after single-dose and multiple-dose administration

  Day 1-Day 11

• Apparent volume of Distribution(Vz/F)of DBPR108 tablets

  Vz/F of DBPR108 tablets will be assessed after single-dose and multiple-dose administration

  Day 1-Day 11

• CL/F of DBPR108 tablets

  Apparent clearance(CL/F) of DBPR108 tablets will be assessed single-dose and multiple-dose administration

  Day 1-Day 11

• Change from baseline in dipeptidyl peptidase-IV inhibition rate

  Change from baseline in dipeptidyl peptidase-IV inhibition rate will be assessed after single-dose and multiple-dose administration

  Day 1-Day 11

• Change from baseline in active glucagon-like peptide1 concentration

  Change from baseline in active glucagon-like peptide1 concentration will be assessed after single-dose and multiple-dose administration

  Day 1-Day 11

Secondary Outcomes (13)

• The number of patients with adverse events

  Throughout the study period, with an average of 1 months

• Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point

  Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11).

• Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.

  Throughout the study period, with an average of 1 months

• Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.

  Throughout the study period, with an average of 1 months

• Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.

  Throughout the study period, with an average of 1 months

Study Arms (3)

50 mg DBPR108 tablets

EXPERIMENTAL

10 patients will be randomized to receive 50 mg DBPR108 tablets.

Drug: DBPR108 tablets

100 mg DBPR108 tablets

EXPERIMENTAL

10 patients will be randomized to receive 100 mg DBPR108 tablets.

Drug: DBPR108 tablets

200 mg DBPR108 tablets

EXPERIMENTAL

10 patients will be randomized to receive 200 mg DBPR108 tablets.

Drug: DBPR108 tablets

Interventions

DBPR108 tablets DRUG

DBPR108 tablets, oral, once daily on Day 1 and Day 3-9 for a total of 8 doses.

100 mg DBPR108 tablets; 200 mg DBPR108 tablets; 50 mg DBPR108 tablets

Eligibility Criteria

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

You may qualify if:

• Patients who meet the World Health Organization (WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes mellitus;
• ≤ age ≤ 75 years old, male or female;
• Body mass index (BMI) within the range of 19-35 kg/m\^2 (inclusive), BMI = weight (kg) / height\^2 (m\^2);
• % ≤Hemoglobin A1c (HbA1c) ≤ 9.5%;
• Patients who voluntarily participate in the study and sign the informed consent form;
• Patients who agree to use contraception from the signing of the informed consent form until 1 month after the end of the last medication.

You may not qualify if:

• Fasting plasma glucose (FPG) \> 13.9 mmol/L;
• The investigator determines that the patients need to use insulin therapy;
• Patients with acute or serious complications of diabetes (including diabetic ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);
• History of severe hypoglycemia (hypoglycemia with severe cognitive impairment and requiring other measures to help recover);
• History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);
• History of allergy to DPP-4 inhibitors or the investigator determines that the patients may be allergic to investigational drug;
• Patients with untreated hyperthyroidism and other diseases, which may affect blood glucose;
• Patients who have used other hypoglycemic drugs within 14 days before the first dose; or patients who are not suitable for this study as determined by the investigator due to taking other hypoglycemic drugs;
• Patients with 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 \> 1.5 \*ULN;
• Abnormal renal function: serum creatinine\>1.5 \* ULN; or eGFR\< 45 mL/min/1.73m\^2;
• White blood cells (WBC) \< 3.0 \*10\^9/L and neutrophil count of peripheral blood \< 1.5 \* 10\^9/L; hemoglobin \< 100 g / L; triglyceride \> 5.7 mmol/L;
• Patients who have the second or third degree atrioventricular block, long Q-T syndrome, or QTc\>500 ms without cardiac pacemaker;
• Patients with any one of HBsAg, hepatitis C antibody, anti-HIV antibody and antibody of treponema pallidum positive;
• Female patients of childbearing age with pregnant test positive or lactating women;

Sponsors & Collaborators

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

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (1)

• Liu W, Yang K, Lin Y, Lu C, Liu J, Zhou H, Wang J, Zhang T, Yao L, Qi H, Zhang X, Jia R, Li X, Jing S. Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes. Clin Pharmacokinet. 2025 May;64(5):703-713. doi: 10.1007/s40262-025-01501-8. Epub 2025 Apr 19.

  PMID: 40252162 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

DBPR108

Condition Hierarchy (Ancestors)

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

Study Officials

• Yang Lin, PhD

  Beijing Anzhen Hospital of Capital Medical University , Beijing, China

  PRINCIPAL INVESTIGATOR

• Shan NA Jing, PhD

  Beijing Anzhen Hospital of Capital Medical University , Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 7, 2021
• Study Start: December 30, 2021
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)