Type 2 DiabetesPhase 3NCT05318326
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Evaluate the Clinical Efficacy and Safety of Yogliptin Tablets
A Phase 3 study testing Yogliptin 400mg group and Yogliptin 200mg group in people with Type 2 Diabetes, run by Chengdu Easton Biopharmaceuticals Co,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Yogliptin 400mg group and Yogliptin 200mg group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Men or women aged 18 to 75 years old at the day of signing the informed consent;
- 2.Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued byChinese Guidelines for the Prevention and Treatment of Type 2 Diabetesin 2020;
- 3.Receive at least 8 weeks of diet and exercise treatment before screening;Not treated with any antidiabetic drugs within 8 weeks before screening;
- 4.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);
- 5.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);
- 6.Screening period Body mass index(BMI) 19.0kg/m2 to 35.0kg/m2 ;
- 7.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
- 8.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.
Who cannot join
- 1.Non-type 2 diabetes: such as type 1 diabetes, secondary diabetes or other special types of diabetes ；
- 2.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;
- 3.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；
- 4.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)) ;
- 5.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);
- 6.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 ;
Show all 27Show fewer
- 7. 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 ;
- 8. 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；
- 9. 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
- 10 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)
- 11 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
- 12 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 ;
- 13 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；
- 14 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 ;
- 15 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 ;
- 16 Use of any of the following drugs or therapies before screening or run-in: Use of other drugs that may affect glucose metabolism, such as systemic glucocorticoids, growth hormone, etc., before screening or within 3 months before run-in;
- 17 Use of any of the following drugs or therapies before screening or run-in: those with cumulative use of insulin and its analogues for more than 28 days in the previous year (except for gestational diabetes treated with insulin and its analogues)
- 18. When screening, any one of the laboratory inspection indicators meets the following standards: ALT/AST> 2.5ULN; Total bilirubin> 2.0ULN; Subjects with current severe renal disease, or eGFR (CKD-EPI2012Scr-CysC) ≤ 60 mL/min/1.73 m2;TG）>5.6mmol/L;Blood amylase>>1.5ULN;HGB<10.0g/dL（100g/L）;
- 19 Any positive HCV antibody, HIV antibody or Treponema pallidum antibody at screening; positive hepatitis B HBsAg, additionally test hepatitis B virus load (HBV-DNA), positive HBsAg and HBV-DNA higher than the lower limit of detection in the local laboratory;
- 20 .The patient may have any contraindications, allergies or hypersensitivity to Test drug (including study drug and placebo) or its excipients, DPP4 drugs
- 21.Patients with a history of joint pain after taking DPP-4 inhibitors ;
- 22.Patients who have received 3 or more times of clinical trial drugs within the past year, or patients who have received 1 time of clinical trial drugs within 1 month before screening ;
- 23 Female subjects who are pregnant, lactating, or planning pregnancy during the study ;
- 24 Male and female subjects of childbearing potential who do not agree to practice contraception during the study. Females of childbearing potential (including those less than 2 years postmenopausal) must agree to practice a reliable method of contraception (e.g., transdermal contraceptive patch, implantable long-acting solution for injection, contraceptive ring, subdermal implant, intrauterine device, or double barrier method (diaphragm+condom) throughout the entire study period) ;
- 25 One or more grade 3 hypoglycemic events without obvious cause during the run-in period ；
- 26 Medication compliance with the lozenge was < 75% or > 125% during the run-in period ；
- 27 The subject has any other factors that the investigator considers inappropriate for the trial 。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality
Lixin Guo
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Evaluate the Clinical Efficacy and Safety of Yogliptin Tablets in Chinese Patients With Type 2 Diabetes Mellitus and Poor Diet and Exercise Control
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.
Read the detailed description
The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 200 mg or 400 mg dose of Yogliptin and matching placebo, or placebo only. During the open-label period, all participants will receive 400 mg dose of Yogliptin.
- Conditions
- Type 2 Diabetes
- Being tested
- placebo group, Yogliptin 400mg group, Yogliptin 200mg group
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo groupDrug
placebo 400mg (4 tablet) , Q1W, oral, week 1 to week 24; Yogliptin 400 mg (4 tablet), Q1W, oral, week 25 to week 52.
Yogliptin 400mg groupDrug
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 groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control group | Placebo comparator | Placebo control group Receives: Drug: placebo group |
| Yogliptin 200mg group | Experimental | Yogliptin 200mg group Receives: Drug: Yogliptin 400mg group |
| Yogliptin 400mg group | Experimental | Yogliptin 400mg group Receives: Drug: Yogliptin 200mg group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change from baseline at week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Measured: Baseline and week 24
Secondary outcomes (7)
FPG Change From Baseline at Week 24 and Week 52
Measured: Baseline, week 24 and week 52
2h-PPG Change From Baseline at Week 24 and Week 44 and Week 52
Measured: Baseline, week 24 and Week 44 and Week 52
Percentage of Patients With HbA1c <6.5%
Measured: Time Frame: Baseline, week 24 and week 52
Percentage of Patients With HbA1c <7.0%
Measured: Baseline, week 24 and week 52
blood pressure Change From Baseline at Week 24 and Week 52
Measured: Baseline, week 24 and week 52
Weight Change From Baseline at Week 24 and Week 52
Measured: Baseline, week 24 and week 52
Fasting lipids From Baseline at Week 24 and Week 52
Measured: Baseline, week 24 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Easton Biopharmaceuticals Co,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lixin Guo, Study director, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318326
- Sponsor's protocol ID
- ChengduEastonBiopharma
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Evaluate the Clinical Efficacy and Safety of Yogliptin Tablets in Chinese Patients With Type 2 Diabetes Mellitus and Poor Diet and Exercise Control
- ClinicalTrials.gov ID
- NCT05318326
- Acronym / sponsor ID
- ChengduEastonBiopharma
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Chengdu Easton Biopharmaceuticals Co,LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 200 mg or 400 mg dose of Yogliptin and matching placebo, or placebo only. During the open-label period, all participants will receive 400 mg dose of Yogliptin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo control group | Placebo comparator | Drug: placebo groupPlacebo control group |
| Yogliptin 200mg group | Experimental | Drug: Yogliptin 400mg groupYogliptin 200mg group |
| Yogliptin 400mg group | Experimental | Drug: Yogliptin 200mg groupYogliptin 400mg group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1.Men or women aged 18 to 75 years old at the day of signing the informed consent;
- 2.Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued byChinese Guidelines for the Prevention and Treatment of Type 2 Diabetesin 2020;
- 3.Receive at least 8 weeks of diet and exercise treatment before screening;Not treated with any antidiabetic drugs within 8 weeks before screening;
- 4.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);
- 5.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);
Key exclusion criteria (27 listed)
- 1.Non-type 2 diabetes: such as type 1 diabetes, secondary diabetes or other special types of diabetes ；
- 2.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;
- 3.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；
- 4.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)) ;
- 5.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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo groupplacebo 400mg (4 tablet) , Q1W, oral, week 1 to week 24; Yogliptin 400 mg (4 tablet), Q1W, oral, week 25 to week 52. | Drug | Placebo control group |
| Yogliptin 400mg groupYogliptin 400mg (4 tablet) , Q1W, oral, week 1 to week 24; Yogliptin 400 mg (4 tablet), Q1W, oral, week 25 to week 52. | Drug | Yogliptin 200mg group |
| Yogliptin 200mg groupYogliptin 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. | Drug | Yogliptin 400mg group |
Primary outcome
HbA1c change from baseline at week 24
Time frame: Baseline and week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
7 secondary outcomes
FPG Change From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
2h-PPG Change From Baseline at Week 24 and Week 44 and Week 52
Time frame: Baseline, week 24 and Week 44 and Week 52
Percentage of Patients With HbA1c <6.5%
Time frame: Time Frame: Baseline, week 24 and week 52
Percentage of Patients With HbA1c <7.0%
Time frame: Baseline, week 24 and week 52
blood pressure Change From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Weight Change From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Fasting lipids From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
Related trials for Type 2 Diabetes
RecruitingObservational study
Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer
Diabetes Mellitus, Type 2, Cancer
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
Diabetes Mellitus, Type 1
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lixin Guo study director
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Yogliptin 400mg group and Yogliptin 200mg group in people with Type 2 Diabetes, run by Chengdu Easton Biopharmaceuticals Co,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yunju Yi (+8613518115493, yiyunju@eastonpharma.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c change from baseline at week 24 (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.