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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03940183

Recruitment Status Completed

First Posted May 7, 2019

Last update posted January 12, 2021

Study Description

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.

  • Condition or Disease:Diabetes Mellitus, Type 2
  • Intervention/Treatment: Drug: Trelagliptin Succinate
    Drug: Placebo Oral Tablet
  • Phase: Phase 3
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 254 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Trelagliptin Succinate Monotherapy for Type 2 Diabetes
  • Actual Study Start Date: July 2019
  • Actual Primary Completion Date: December 2020
  • Actual Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Trelagliptin succinate 100 mg
Tablets,100mg per tablet,oral, once a week, 100mg each time, continuous medication for a total of 24 weeks
Drug: Trelagliptin Succinate
the experimental group will use trelagliptin succinate 100 mg for 24weeks
Placebo Comparator: Placebo Oral Tablet
Tablets,N/A,oral, once a week, one tablet each time, continuous medication for a total of 24 weeks
Drug: Placebo Oral Tablet
the placebo Comparator groups use placebo oral tablet for 24weeks
Outcome Measures
  • Primary Outcome Measures: 1. HbA1c [ Time Frame: Baseline, week 24 ]
    Changes in HbA1c compared to baseline at week 24
  • Secondary Outcome Measures: 1. Body Mass Index [ Time Frame: Baseline, week 24 ]
    Changes in Body Mass Index (kg/m^2)compared to baseline at week 24
  • 2. HbA1c [ Time Frame: Baseline, week 16 ]
    Changes in HbA1c compared to baseline at week 16
  • 3. Fasting blood glucose [ Time Frame: Baseline, week 16,week 24 ]
    Changes in Fasting blood glucose compared to baseline at week 16,week 24
  • 4. 2-hour postprandial blood glucose [ Time Frame: Baseline, week 24 ]
    Changes in 2-hour postprandial blood glucose compared to baseline at week 24
  • 5. fasting insulin [ Time Frame: Baseline, week 24 ]
    Changes in fasting insulin compared to baseline at week 24
  • 6. fasting glucagon [ Time Frame: Baseline, week 24 ]
    Changes in fasting glucagon compared to baseline at week 24
  • 7. active Glucagon-like peptide-1(GLP-1) level [ Time Frame: Baseline, week 24 ]
    Changes in active Glucagon-like peptide-1(GLP-1) level compared to baseline at 24
  • 8. The percentage of HbA1c<6.5% and HbA1c<7% [ Time Frame: week 24 ]
    The percentage of HbA1c<6.5% and HbA1c<7% at week 24
  • 9. body weight [ Time Frame: Baseline, week 24 ]
    Changes in body weight(Kg)compared to baseline at week 24
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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 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.

Contacts and Locations
Contacts
Locations

China, Beijing
Beijing Hospital
Beijing

Sponsors and Collaborators

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

Study Chair: yueying peng Clinical Medicine Department CSPC R&D Business Division

More Information
  • Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
  • ClinicalTrials.gov Identifier: NCT03940183 History of Changes
  • Other Study ID Numbers: CSPC/HC1425/201801
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: January 12, 2021
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: type 2 diabetes
    trelagliptin succinate
    monotherapy
  • Additional relevant MeSH terms: Diabetes Mellitus Diabetes Mellitus, Type 2