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

CSPC Pharmaceutical Group

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108; Drug: DBPR108; Placebo matching sitagliptin; Drug: Placebo matching DBPR108; Sitagliptin; DBPR108

Study type: Interventional

Funder types: Industry

Identifiers

NCT04161430

CSPC/DBPR108201903/PRO-III-1

Details and patient eligibility

About

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.

Enrollment: 766 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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766 participants in 3 patient groups, including a placebo group

DRBP108

Experimental group

Description:

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

Treatment:

Drug: DBPR108; Placebo matching sitagliptin

Sitagliptin

Active Comparator group

Description:

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

Treatment:

Drug: Placebo matching DBPR108; Sitagliptin; DBPR108

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108