Clinical trial NCT04161430: A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Comparator, Placebo-Controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: DBPR108
Type 2 diabetes mellitus
DPP4 inhibitor
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 766
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in HbA1c (%) compared to placebo comparator at week 24
timeFrame: Baseline, week 24
Secondary outcomes:
measure: Change from baseline in HbA1c (%) compared to active comparator at week 24
timeFrame: Baseline, week 24
measure: The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 24
timeFrame: Week 24
measure: Change from baseline in HbA1c (%) at week 12, week 40, week 52
timeFrame: Baseline, week 12, week 40, week 52
measure: The percentage of subjects with HbA1c≤6.5% and HbA1c≤7% at week 12, week 40, week 52
timeFrame: Week 12, week 40, week 52
measure: Change from baseline in fasting plasma glucose/2-hour postprandial plasma glucose/body weight at week 12,week 24
timeFrame: Baseline, week 12, week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Changsha
country: China
facility: the No, 1 People's Hospital of Changsha
state: Huan Province
Study officials:
affiliation: Department of Medicine, CSPC Clinical Development Division
name: Kun Lou
role: STUDY_DIRECTOR
References: