Clinical trial NCT03940183: Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Trelagliptin Succinate Monotherapy for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
monotherapy
trelagliptin succinate
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 254
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: The trial used a randomized, double-blind, placebo-controlled, superior-effect design, multicenter clinical study.

The trial was divided into a test group and a placebo group,the two groups were randomized in a 1:1 ratio and planned to enroll 240 patients with type 2 diabetes. After 2 weeks of screening, all subjects entered the treatment period,which was 24 weeks, and 1 week period of follow-up.

Detailed description: The trial was divided into a test group and a placebo group: the test group was given trelagliptin succinate tablets, and the placebo group was given placebo. The test group and the placebo group were randomized in a 1:1 ratio and planned to enroll 240 patients with type 2 diabetes. After 2 weeks of screening, all subjects entered the treatment period,which was 24 weeks, and 1 week period of follow-up.

All subjects were asked to continue their current diabetes diet and physical activity treatment plan throughout the study period.

Eligibility criteria: Inclusion Criteria:

* Subjects who fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
* 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:

  * Initially diagnosed type 2 diabetic patients;
  * Patients who with type 2 diabetes diagnosed within 2 years of 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 (ie, 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;
* Female subjects do not have a fertility plan one month before the trial and all the subjects do not have a fertility plan during and one month after the trial.

Exclusion Criteria:

* Fasting plasma glucose≥13.9mmol/L or a history of severe hypoglycemia (blood sugar below 2.8mmol/L);
* Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg during screening;
* Positive for Acquired Immure Deficiency Syndrome（AIDS）or syphilis testing;
* Active hepatitis B virus infection or hepatitis C virus infection;
* History of acute or chronic liver disease, and Aspartate aminotransferase(AST) or Alanine minotransferase(ALT)\> 2.5 times of reference range or total bilirubin\> 1.5 times of reference range during the screening period;
* Renal insufficiency subjects, the serum creatinine above 1.5 times of reference range during the screening period;
* The white blood cells are outside of the reference range, hemoglobin below the reference range, triglyceride\>5.7mmol/L during the screening period;
* Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemia coma) ,or severe chronic complications (proliferative diabetic retinopathy, diabetic nephropathy);
* Oral or intravenous use of glucocorticoids or regular application (ie continuous use more than one week within 4 weeks before screening time) with large doses of thiazide diuretics (hydrochlorothiazide, chlorothiazide, etc.);
* Subjects without a pacemaker, the 12-lead ECG showed II or III degree atrioventricular block, long QT syndrome or corrected QT interval （QTc）\>450ms or atrial fibrillation during the screening period;
* Active heart disease (including acute myocardial infarction, unstable angina) , moderate to severe congestive heart failure (NYHA class III or IV), or planned for coronary artery bypass grafting or transmyocardial laser revascularization half year before 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;
* Endocrine diseases such as hypercortisolism or polycystic ovary syndrome that may affect blood glucose levels;
* Inflammatory bowel disease, colon ulcer, partial intestinal obstruction or obvious digestive and dysfunction chronic bowel disease;
* Active pancreatitis, cholecystitis, gallstones and other digestive diseases;
* Using weight loss surgery within 3 months before screening period or using weight-loss drugs (including traditional Chinese medicine diet pills) within2 months before screening period;
* History of drug or drug abuse or alcoholics;
* Blood donation within 2 months before screening includes blood components or massive blood loss (≥400mL),or receiving blood transfusion or using blood products;
* History of allergies with similar drugs (DPP-4 inhibitors) or those who are judged by the investigator to be allergic to the test drug;
* Subjects who are participating in other clinical trials or who have participated in other drug trials within 3 months prior to screening;
* Pregnancy (defined as positive in pregnancy test), lactating women;
* Not suitable for this clinical trial judged by the investigator.

Primary outcomes:
measure: HbA1c
timeFrame: Baseline, week 24
Secondary outcomes:
measure: HbA1c
timeFrame: Baseline, week 16
measure: Fasting blood glucose
timeFrame: Baseline, week 16，week 24
measure: 2-hour postprandial blood glucose
timeFrame: Baseline, week 24
measure: fasting insulin
timeFrame: Baseline, week 24
measure: fasting glucagon
timeFrame: Baseline, week 24
measure: active Glucagon-like peptide-1（GLP-1） level
timeFrame: Baseline, week 24
measure: The percentage of HbA1c<6.5% and HbA1c<7%
timeFrame: week 24
measure: body weight
timeFrame: Baseline, week 24
measure: Body Mass Index
timeFrame: Baseline, week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Clinical Medicine Department CSPC R&D Business Division
name: yueying peng
role: STUDY_CHAIR
References: