Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes

NCT03940183 | Completed Phase 3

• 1 other identifier: CSPC/HC1425/201801
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetes; monotherapy; trelagliptin succinate

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Changes in HbA1c compared to baseline at week 24

  Baseline, week 24

Secondary Outcomes (9)

• HbA1c

  Baseline, week 16

• Fasting blood glucose

  Baseline, week 16，week 24

• 2-hour postprandial blood glucose

  Baseline, week 24

• fasting insulin

  Baseline, week 24

• fasting glucagon

  Baseline, week 24

Study Arms (2)

Trelagliptin succinate 100 mg

EXPERIMENTAL

Tablets,100mg per tablet,oral, once a week, 100mg each time, continuous medication for a total of 24 weeks

Drug: Trelagliptin Succinate

Placebo Oral Tablet

PLACEBO COMPARATOR

Tablets,N/A,oral, once a week, one tablet each time, continuous medication for a total of 24 weeks

Drug: Placebo Oral Tablet

Interventions

Trelagliptin Succinate DRUG

the experimental group will use trelagliptin succinate 100 mg for 24weeks

Trelagliptin succinate 100 mg

Placebo Oral Tablet DRUG

the placebo Comparator groups use placebo oral tablet for 24weeks

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤ 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);
• kg/m\^2 ≤ Body Mass Index（BMI ）≤ 35kg/m\^2;
• % ≤ 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

trelagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• yueying peng

  Clinical Medicine Department CSPC R&D Business Division

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 7, 2019
• Study Start: July 8, 2019
• Primary Completion: December 3, 2020
• Study Completion: December 28, 2020
• Last Updated: January 12, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)