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

NCT ID: NCT04161430

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 766 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2022-06-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DRBP108

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

Group Type: EXPERIMENTAL

DBPR108; Placebo matching sitagliptin

Intervention Type: 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.

Sitagliptin

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

Group Type: ACTIVE_COMPARATOR

Placebo matching DBPR108; Sitagliptin; DBPR108

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• 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

Kun Lou

Role: STUDY_DIRECTOR

Department of Medicine, CSPC Clinical Development Division

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

the No, 1 People's Hospital of Changsha

Changsha, Huan Province, China

Countries

China

Other Identifiers

CSPC/DBPR108201903/PRO-III-1

Identifier Type: -

Identifier Source: org_study_id