A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients

NCT04161430 | Completed Phase 3

• 1 other identifier: CSPC/DBPR108201903/PRO-III-1
• Study Type: interventional
• Target: 766
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the efficacy and safety of 100 mg DRBP108 tablets in the treatment of type 2 diabetes mellitus. A total of 750 subjects will be randomly allocated to three groups: DRBP108, active comparator and placebo comparator, in a 3:1:1 ratio. The purpose of this study is to evaluate whether 24 weeks of DRBP108 treatment will adequately reduce hemoglobin A1C levels in T2DM subjects.

Conditions

Type 2 Diabetes Mellitus

Keywords

DBPR108; Type 2 diabetes mellitus; DPP4 inhibitor

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c (%) compared to placebo comparator at week 24

  Change reflects the experimental value (baseline subtract) minus the placebo comparator value (baseline subtract) at week 24. HbA1c represents the percentage of glycosylated hemoglobin.

  Baseline, week 24

Secondary Outcomes (5)

• Change from baseline in HbA1c (%) compared to active comparator at week 24

  Baseline, week 24

• The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24

  Week 24

• Change from baseline in HbA1c (%) at week 12, week 40, week 52

  Baseline, week 12, week 40, week 52

• The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 12, week 40, week 52

  Week 12, week 40, week 52

• Change from baseline in fasting plasma glucose/2-hour postprandial plasma glucose/body weight at week 12,week 24

  Baseline, week 12, week 24

Study Arms (3)

DRBP108

EXPERIMENTAL

Phase A (Weeks 1-24): DBPR108 100mg + placebo matching Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg

Drug: DBPR108; Placebo matching sitagliptin

Sitagliptin

ACTIVE COMPARATOR

Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg + Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg

Drug: Placebo matching DBPR108; Sitagliptin; DBPR108

Placebo

PLACEBO COMPARATOR

Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg + placebo matching Sitagliptin 100 mg; Phase B (Weeks 25-52): DBPR108 100 mg

Drug: Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108

Interventions

DBPR108; Placebo matching sitagliptin DRUG

Phase A (Weeks 1-24): DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks. Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.

DRBP108

Placebo matching DBPR108; Sitagliptin; DBPR108 DRUG

Phase A (Weeks 1-24): Placebo matching DBPR108 100mg once daily under fasted conditions for 24 weeks; Sitagliptin 100 mg once daily under fasted conditions for 24 weeks. Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.

Sitagliptin

Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108 DRUG

Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks. Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks.

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects who meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes;
• ≤ age ≤ 75 years old, male or female;
• kg/m\^2 ≤ Body Mass Index（BMI ）≤ 35kg/m\^2;
• Subjects with type 2 diabetes mellitus who did not regularly take oral hypoglycemic drugs at least 8 weeks before screening (i.e., continuous medication for \<1 week);
• % ≤ HbA1c ≤ 9.5%;
• Subjects voluntarily participate in the trial and sign the informed consent form;
• Subjects agree to use contraception from the signing of the informed consent form to the end of 1 month of the last medication.

You may not qualify if:

• FPG \> 13.9 mmol/L;
• A history of severe hypoglycemia (that is, hypoglycemia with severe cognitive impairment and requiring other measures to help recover);
• A history of allergy to similar drugs (DPP-4 inhibitors) or those who have been judged by the investigator to be allergic to tested drugs;
• Uncured hyperthyroidism or other diseases may cause secondary blood sugar elevation;
• Continuous use of glucocorticoids within 4 weeks prior to screening or may uninterrupted use glucocorticoids ≥14 days during the trial (except for external use and inhalation)
• Subjects with chronic bowel disease associated with inflammatory bowel disease, partial intestinal obstruction, or obvious digestive and absorption disorders;
• Subjects with infectious diseases(all positive for HBsAg, HBeAg, HBcAb, or positive for hepatitis C antibody, or positive for anti-HIV antibody); Female subjects of childbearing age are positive in pregnancy test or are lactating;
• Subjects with a history of alcoholism or drug abuse;
• Subjects have the clinically significant unstable diseases;
• Not suitable for this clinical trial judged by the investigator.

Sponsors & Collaborators

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

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100000, China

Location

the No, 1 People's Hospital of Changsha

Changsha, Huan Province, 410005, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

DBPR108; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

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: October 29, 2019
• First Posted: November 13, 2019
• Study Start: January 2, 2020
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: August 17, 2022

Record last verified: 2021-09

Locations

CN (2)