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出境医 / 临床实验 / Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes

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

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 Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Trelagliptin Succinate Drug: Placebo Oral Tablet 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 8, 2019
Actual Primary Completion Date : December 3, 2020
Actual Study Completion Date : December 28, 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. HbA1c [ Time Frame: Baseline, week 16 ]
    Changes in HbA1c compared to baseline at week 16

  2. Fasting blood glucose [ Time Frame: Baseline, week 16,week 24 ]
    Changes in Fasting blood glucose compared to baseline at week 16,week 24

  3. 2-hour postprandial blood glucose [ Time Frame: Baseline, week 24 ]
    Changes in 2-hour postprandial blood glucose compared to baseline at week 24

  4. fasting insulin [ Time Frame: Baseline, week 24 ]
    Changes in fasting insulin compared to baseline at week 24

  5. fasting glucagon [ Time Frame: Baseline, week 24 ]
    Changes in fasting glucagon compared to baseline at week 24

  6. 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

  7. 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

  8. body weight [ Time Frame: Baseline, week 24 ]
    Changes in body weight(Kg)compared to baseline at week 24

  9. Body Mass Index [ Time Frame: Baseline, week 24 ]
    Changes in Body Mass Index (kg/m^2)compared to baseline at week 24


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years 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 <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.
Contacts and Locations

Locations
Layout table for location information
China, Beijing
Beijing Hospital
Beijing, Beijing, China
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
Layout table for investigator information
Study Chair: yueying peng Clinical Medicine Department CSPC R&D Business Division
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date January 12, 2021
Actual Study Start Date  ICMJE July 8, 2019
Actual Primary Completion Date December 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2019)
HbA1c [ Time Frame: Baseline, week 24 ]
Changes in HbA1c compared to baseline at week 24
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2019)
  • HbA1c [ Time Frame: Baseline, week 16 ]
    Changes in HbA1c compared to baseline at week 16
  • Fasting blood glucose [ Time Frame: Baseline, week 16,week 24 ]
    Changes in Fasting blood glucose compared to baseline at week 16,week 24
  • 2-hour postprandial blood glucose [ Time Frame: Baseline, week 24 ]
    Changes in 2-hour postprandial blood glucose compared to baseline at week 24
  • fasting insulin [ Time Frame: Baseline, week 24 ]
    Changes in fasting insulin compared to baseline at week 24
  • fasting glucagon [ Time Frame: Baseline, week 24 ]
    Changes in fasting glucagon compared to baseline at week 24
  • 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
  • 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
  • body weight [ Time Frame: Baseline, week 24 ]
    Changes in body weight(Kg)compared to baseline at week 24
  • Body Mass Index [ Time Frame: Baseline, week 24 ]
    Changes in Body Mass Index (kg/m^2)compared to baseline at week 24
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2019)
  • HbA1c [ Time Frame: Baseline, week 16 ]
    Changes in HbA1c compared to baseline at week 16
  • Fasting blood glucose [ Time Frame: Baseline, week 16,week 24 ]
    Changes in HbA1c compared to baseline at week 16,week 24
  • 2-hour postprandial blood glucose [ Time Frame: Baseline, week 24 ]
    Changes in 2-hour postprandial blood glucose compared to baseline at week 24
  • fasting insulin [ Time Frame: Baseline, week 24 ]
    Changes in fasting insulin compared to baseline at week 24
  • fasting glucagon [ Time Frame: Baseline, week 24 ]
    Changes in fasting glucagon compared to baseline at week 24
  • 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
  • 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
  • body weight [ Time Frame: Baseline, week 24 ]
    Changes in body weight(Kg)compared to baseline at week 24
  • Body Mass Index [ Time Frame: Baseline, week 24 ]
    Changes in Body Mass Index (kg/m^2)compared to baseline at week 24
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Trelagliptin Succinate Monotherapy for Type 2 Diabetes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Trelagliptin Succinate
    the experimental group will use trelagliptin succinate 100 mg for 24weeks
  • Drug: Placebo Oral Tablet
    the placebo Comparator groups use placebo oral tablet for 24weeks
Study Arms  ICMJE
  • Experimental: Trelagliptin succinate 100 mg
    Tablets,100mg per tablet,oral, once a week, 100mg each time, continuous medication for a total of 24 weeks
    Intervention: Drug: Trelagliptin Succinate
  • Placebo Comparator: Placebo Oral Tablet
    Tablets,N/A,oral, once a week, one tablet each time, continuous medication for a total of 24 weeks
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2020)
254
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2019)
240
Actual Study Completion Date  ICMJE December 28, 2020
Actual Primary Completion Date December 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940183
Other Study ID Numbers  ICMJE CSPC/HC1425/201801
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study Sponsor  ICMJE CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: yueying peng Clinical Medicine Department CSPC R&D Business Division
PRS Account CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP