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

A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Comparator, Placebo-Controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: DBPR108; Placebo matching sitagliptin; Drug: Placebo matching DBPR108; Sitagliptin; DBPR108; Drug: Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108

• Study Type: Interventional
• Enrollment (Actual): 766
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Peking University First Hospital
  • Huan Province
    • Changsha, Huan Province, China, 410005
      • the No, 1 People's Hospital of Changsha

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:

• Subjects who meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes;
• 18 ≤ age ≤ 75 years old, male or female;
• 19kg/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);
• 7.0% ≤ 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DRBP108; 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; 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.
ACTIVE_COMPARATOR: Sitagliptin; 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; 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.
PLACEBO_COMPARATOR: Placebo; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in HbA1c (%) compared to active comparator at week 24	Change reflects the experimental value (baseline subtract) minus the active comparator value (baseline subtract) at week 24. HbA1c represents the percentage of glycosylated hemoglobin.	Baseline, week 24
The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24	Clinical response will be assessed by 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	Change reflects the experimental value minus the baseline value at week 12, week 40, week 52. HbA1c represents the percentage of glycosylated hemoglobin.	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	Clinical response will be assessed by 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	Change reflects the experimental value minus the baseline value in the fasting plasma glucose/2-hour postprandial plasma glucose/body weight at week 12,week 24. Plasma glucose was measured on a fasting basis or 2 hours after a standard meal, and is expressed as mmol/L. Body weight is expressed as kg.	Baseline, week 12, week 24

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2020
• Primary Completion (ACTUAL): June 27, 2022
• Study Completion (ACTUAL): June 27, 2022

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (ACTUAL): November 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; DPP4 inhibitor; DBPR108
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: CSPC/DBPR108201903/PRO-III-1

Drug and device information, study documents

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