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

NCT ID: NCT05146869

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-30
• Study Completion Date: 2022-03-28

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.

Detailed Description

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, single-dose and multiple-dose of DBPR108 tablets in Chinese Type 2 Diabetes Mellitus Patients. The 30 eligible patients will be randomized to receive 50 mg, 100 mg, or 200 mg DBPR108 tablets.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

50 mg DBPR108 tablets

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

Group Type: EXPERIMENTAL

DBPR108 tablets

Intervention Type: DRUG

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

100 mg DBPR108 tablets

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

Group Type: EXPERIMENTAL

DBPR108 tablets

Intervention Type: DRUG

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

200 mg DBPR108 tablets

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

Group Type: EXPERIMENTAL

DBPR108 tablets

Intervention Type: DRUG

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

Interventions

DBPR108 tablets

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients who meet the World Health Organization (WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes mellitus;

2. 18 ≤ age ≤ 75 years old, male or female;

3. Body mass index (BMI) within the range of 19-35 kg/m^2 (inclusive), BMI = weight (kg) / height^2 (m^2);

4. 7.0% ≤Hemoglobin A1c (HbA1c) ≤ 9.5%;

5. Patients who voluntarily participate in the study and sign the informed consent form;

6. Patients who agree to use contraception from the signing of the informed consent form until 1 month after the end of the last medication.

Exclusion Criteria

1. Fasting plasma glucose (FPG) > 13.9 mmol/L;

2. The investigator determines that the patients need to use insulin therapy;

3. Patients with acute or serious complications of diabetes (including diabetic ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);

4. History of severe hypoglycemia (hypoglycemia with severe cognitive impairment and requiring other measures to help recover);

5. History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);

6. History of allergy to DPP-4 inhibitors or the investigator determines that the patients may be allergic to investigational drug;

7. Patients with untreated hyperthyroidism and other diseases, which may affect blood glucose;

8. 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;

9. Patients with inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders;

10. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 3 * upper limit of normal (ULN), or total bilirubin > 1.5 *ULN;

11. Abnormal renal function: serum creatinine>1.5 * ULN; or eGFR< 45 mL/min/1.73m^2;

12. 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;

13. Patients who have the second or third degree atrioventricular block, long Q-T syndrome, or QTc>500 ms without cardiac pacemaker;

14. Patients with any one of HBsAg, hepatitis C antibody, anti-HIV antibody and antibody of treponema pallidum positive;

15. Female patients of childbearing age with pregnant test positive or lactating women;

16. History of alcohol or drug abuse within 3 months before screening, alcohol abuse is average alcohol intake more than 14 units alcohol (1 unit=12 ounces or 360 mL of beer,1.5 ounces or 45 mL spirits with 40% alc/vol, 5 ounces or 150 mL grape wine); or intake any other products containing alcohol within 2 days before the first administration of investigational product;

17. Patients who smoke more than 5 cigarettes per day within 3 months prior to screening;

18. Patients with consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) within 2 days before the first administration in treatment period , or patients who have strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, etc;

19. Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening;

20. Patients with the following diseases:

1. Serious dysrhythmias, obvious left ventricular dysfunction, New York Heart Association (NYHA) functional class III or IV;

2. History of unstable angina pectoris, myocardial infarction, or other high-risk coronary artery diseases;

3. Uncontrolled hypertension, systolic pressure ≥160 mmHg or diastolic pressure ≥100 mmHg;

4. History of cancer , organ transplantation;

5. History of epilepsy, psychosis, severe depression, etc.

21. Not suitable for this study as determined by the investigator due to other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yang Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital of Capital Medical University , Beijing, China

Shan NA Jing, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital of Capital Medical University , Beijing, China

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40252162 (View on PubMed)

Other Identifiers

HA1118-014

Identifier Type: -

Identifier Source: org_study_id