Clinical trial NCT04124484: DBPR108 Tablets in Type 2 Diabetes Mellitus Patients
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of DBPR108 Tablets for Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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: 2019-10-11
Enrollment: 276
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 evaluate DRBP108 in the treatment of type 2 diabetes mellitus. The patients were randomly allocated to four groups: 50 mg, 100 mg, 200 mg and placebo group.

Detailed description: This study was to evaluate DRBP108 in the treatment of type 2 diabetes mellitus. A total of 268 subjects were randomly allocated to four treatment arms: 50 mg, 100 mg, 200 mg or placebo group, in a 1:1:1:1 ratio.

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;
* One of the following conditions:

  1. Initial diagnosis of type 2 diabetes mellitus;
  2. Patients who with type 2 diabetes diagnosed within 2 years before screening period and are treated with single-agent oral hypoglycemic agents until screening, and do not take the medicine regularly for at least 8 weeks (i.e., continuous medication for \<1 week);
* 19kg/m\^2 ≤ Body Mass Index（BMI ）≤ 35kg/m\^2;
* 7.0% ≤ HbA1c ≤ 10.0%;
* Female subjects of childbearing age are negative in pregnancy test;
* All the subjects do not have a fertility plan during and three month after the trial;
* Subjects who fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;

Exclusion Criteria:

* FPG \> 15 mmol/L;
* Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg during screening period;
* Those who are known to be positive for HIV and syphilis;
* known active hepatitis B virus infection, hepatitis C virus infection;
* For patients with obvious liver diseases and chronic liver diseases, AST or ALT in screening stage was twice the normal upper limit.
* In patients with renal insufficiency, serum creatinine at screening stage was 1.5 times higher than the upper limit of normal value;
* Leukocyte and hemoglobin \< lower limit of normal value, triglyceride \> 5.7 mmol/L in screening stage;
* With diabetic acute complications (including diabetic ketoacidosis, hypertonic non-ketoacid diabetic coma, lactic acidosis and hypoglycemic coma), chronic complications (proliferative diabetic retinopathy, diabetic nephropathy);
* Use of insulin, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist or any combination of two or more oral hypoglycemic drugs within 8 weeks before screening time.
* Those who need insulin therapy;
* Using and Used of glucocorticoids within 2 weeks before screening time.
* without a pacemaker, the 12-lead ECG showed II or III degree atrioventricular block, long QT syndrome or corrected QT interval （QTc）\>500ms or atrial fibrillation during the screening period;
* History of epilepsy, mental illness, major depression, or previous thyroid function abnormal and still being treated, or those with organ transplants, severe chronic lung disease, and other serious heart disease, cerebrovascular disease, blood disease;
* Inflammatory bowel disease, colon ulcer, partial intestinal obstruction or chronic intestinal diseases associated with digestive and absorption diseases;
* Active pancreatitis, cholecystitis, gallstones and other digestive diseases;
* History of severe hypoglycemia;
* History of allergies with similar drugs (DPP-4 inhibitors) or those who are judged by the investigator to be allergic to the test drug;
* Pregnancy, lactating women;
* Subjects who are participating in other clinical trials or who have participated in other drug trials within 3 months prior to screening;
* Not suitable for this clinical trial judged by the investigator.

Primary outcomes:
measure: HBA1c
timeFrame: Baseline, week 12
Secondary outcomes:
measure: HBA1c
timeFrame: Baseline, week 8, week4
measure: Fasting plasma glucose
timeFrame: Baseline, week 4，week 8, week 12
measure: 2-hour postprandial plasma glucose
timeFrame: Baseline, week 4，week 8, week 12
measure: fasting glucagon
timeFrame: Baseline, week 4，week 8, week 12
measure: fasting Insulin
timeFrame: Baseline, week 4，week 8, week 12
measure: active Glucagon-like peptide-1（GLP-1）
timeFrame: Baseline, week 4，week 8, week 12
measure: The percentage of HbA1c≤6.5% or HbA1c≤7%
timeFrame: week 12
measure: body weight
timeFrame: Baseline, week 4，week 8, week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: First Hospital of Peking Unversity
state: Beijing
Study officials:
References:
citation: Wang W, Yao J, Guo X, Guo Y, Yan C, Liu K, Zhang Y, Wang X, Li H, Wen Z, Wang X, Li S, Xiao X, Liu W, Li Z, Zhang L, Shao S, Ye S, Qin G, Li Y, Li F, Zhang X, Li X, Peng Y, Deng H, Xu X, Zhou L, Huang Y, Cao M, Xia X, Shi M, Dou J, Yuan J. Efficacy and safety of DBPR108 monotherapy in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled, phase II clinical trial. Curr Med Res Opin. 2020 Jul;36(7):1107-1115. doi: 10.1080/03007995.2020.1761311. Epub 2020 May 12.