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

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    750
  • sponsor
    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Updated on 4 October 2021
type 2 diabetes mellitus
hemoglobin a1c
sitagliptin
hypoglycemic agents
oral hypoglycemic

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.

Details
Condition NIDDM, Diabetes Mellitus, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment DBPR108; Placebo matching sitagliptin, Placebo matching DBPR108; Sitagliptin; DBPR108, Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108
Clinical Study IdentifierNCT04161430
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Last Modified on4 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 IndexBMI 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)
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
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