A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Evaluate the Clinical Efficacy and Safety of Yogliptin Tablets

NCT05318326 | Unknown Phase 3

• 1 other identifier: ChengduEastonBiopharma
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy of Yogliptin (as monotherapy) compared with placebo after 24 weeks, and the safety (up to 52 weeks) of Yogliptin in Chinese patients with Type 2 diabetes who are insufficient glycaemic control with diet and exercise.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c change from baseline at week 24

  Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

  Baseline and week 24

Secondary Outcomes (7)

• FPG Change From Baseline at Week 24 and Week 52

  Baseline, week 24 and week 52

• 2h-PPG Change From Baseline at Week 24 and Week 44 and Week 52

  Baseline, week 24 and Week 44 and Week 52

• Percentage of Patients With HbA1c <6.5%

  Time Frame: Baseline, week 24 and week 52

• Percentage of Patients With HbA1c <7.0%

  Baseline, week 24 and week 52

• blood pressure Change From Baseline at Week 24 and Week 52

  Baseline, week 24 and week 52

Study Arms (3)

Placebo control group

PLACEBO COMPARATOR

Placebo control group

Drug: placebo group

Yogliptin 200mg group

EXPERIMENTAL

Yogliptin 200mg group

Drug: Yogliptin 400mg group

Yogliptin 400mg group

EXPERIMENTAL

Yogliptin 400mg group

Drug: Yogliptin 200mg group

Interventions

placebo group DRUG

placebo 400mg (4 tablet) , Q1W, oral, week 1 to week 24; Yogliptin 400 mg (4 tablet), Q1W, oral, week 25 to week 52.

Placebo control group

Yogliptin 400mg group DRUG

Yogliptin 400mg (4 tablet) , Q1W, oral, week 1 to week 24; Yogliptin 400 mg (4 tablet), Q1W, oral, week 25 to week 52.

Yogliptin 200mg group

Yogliptin 200mg group DRUG

Yogliptin 200mg (2 tablet) and placebo 200 mg (2 tablet), Q1W, oral, week 1 to week 24; Yogliptin 400 mg (4 tablet), Q1W, oral, week 25 to week 52.

Yogliptin 400mg group

Eligibility Criteria

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

You may qualify if:

• Men or women aged 18 to 75 years old at the day of signing the informed consent;
• Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued byChinese Guidelines for the Prevention and Treatment of Type 2 Diabetesin 2020;
• Receive at least 8 weeks of diet and exercise treatment before screening;Not treated with any antidiabetic drugs within 8 weeks before screening;
• Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 11% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.5% (central laboratory test) Measurement);
• fasting blood glucose(FPG): Screening period: FPG≤15.0mmol/L (tested by the research center), when randomly enrolled: FPG≤15.0mmol/L (central laboratory test) Measurement);
• Screening period Body mass index(BMI) 19.0kg/m2 to 35.0kg/m2 ;
• Agree to maintain the same diet and exercise habits throughout the trial and be willing and able to accurately use a home blood glucose meter for self-monitoring and recording of blood glucose
• Can understand the procedures and methods of this study, willing to strictly abide by the clinical trial protocol to complete this trial, and voluntarily sign an informed consent.

You may not qualify if:

• Non-type 2 diabetes: such as type 1 diabetes, secondary diabetes or other special types of diabetes ；
• History or condition of any of the following at screening or run-in:Those who have a history of diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lactic acidosis and other acute complications of diabetes within 6 months before screening;
• History or condition of any of the following at screening or run-in:Unstable condition or severe diabetic complications such as proliferative retinopathy or maculopathy, severe diabetic neuropathy, intermittent claudication, diabetic foot in the past 6 months；
• History or condition of any of the following at screening or run-in:Three or more episodes of grade 3 hypoglycemia in the past 6 months (according to the diagnostic criteria for hypoglycemia in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)) ;
• History or condition of any of the following at screening or run-in:Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of);
• History or condition of any of the following at screening or run-in:Hemorrhagic stroke or ischemic stroke within the past 6 months, and is not suitable for this clinical trial judged by the investigator ;
• \. History or condition of any of the following at screening or run-in:Previous history of other serious endocrine diseases affecting glucose metabolism, such as multiple endocrine neoplasia, limb hypertrophy syndrome, Cushing's syndrome, etc., which are not suitable for this clinical trial judged by the ;
• \. History or condition of any of the following at screening or run-in:Patients with previous severe digestive system diseases, nutritional metabolic diseases and rheumatic diseases, who are not suitable to participate in this clinical trial as judged by the investigator；
• \. any of the following medical history or conditions at screening or run-in: current thyroid dysfunction not controlled with stable drug dose, and clinically significant abnormalities in thyroid function test results at screening
• Any of the following medical history or conditions at screening or run-in: History or presence of malignancy (except for malignancies that have not recurred in the last 5 years)
• History or condition of any of the following at screening or run-in: Presence of significant psychiatric disorder or speech disorder Unwilling or unable to fully understand and collaborate Contacts and Locations
• Any of the following medical history or conditions at screening or run-in: significant infection or major surgery within 6 months prior to screening, which, in the judgment of the investigator, would make the patient inappropriate for this clinical trial ;
• History or conditions of any of the following at screening or run-in: those with a history or clinical evidence of acute or chronic pancreatitis；
• History or condition of any of the following at screening or run-in: poorly controlled blood pressure, ie, systolic blood pressure (SBP) \> 160 mmHg and/or diastolic blood pressure (DBP) \> 100 mmHg ;
• Use of any of the following medications or therapies prior to Screening or Run-in: Dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists prior to Screening or within 3 months prior to Run-in ;

Sponsors & Collaborators

• Chengdu Easton Biopharmaceuticals Co,Ltd: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Population Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Lixin Guo

  Beijing Hospital

  STUDY DIRECTOR

Central Study Contacts

yunju Yi

CONTACT

+8613518115493; yiyunju@eastonpharma.cn

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: March 31, 2022
• First Posted: April 8, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CN (1)