Type 2 Diabetes MellitusPhase 3NCT05326490
Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poor Glycemic Control Via Metformin Hydrochloride Monotherapy
A Phase 3 study testing PB-201 and Metformin hydrochloride in people with Type 2 Diabetes Mellitus, run by PegBio Co., Ltd. at 1 site in China.
Trial summary
This is a Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients with Poor Glycemic Control via Metformin Hydrochloride Monotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- PB-201 and Metformin hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 546 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2022to 31 Oct 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
- Patients must meet all of the following inclusion criteria to be eligible for this study:
- Males or females aged ≥18 years and ≤ 75 years at screening;
- Definitely diagnosed T2DM patients who meet the diagnostic criteria for type 2 diabetes mellitus issued by WHO in 1999;
- Receive a stable dose of metformin hydrochloride monotherapy ≥ 8 weeks on the basis of diet and exercise interventions before screening and the dose of metformin hydrochloride is ≥ 1500mg/day or the maximum tolerated dose (<1500mg/day but ≥ 1000mg/day);
- The Glycosylated hemoglobin (HbA1c) must meet the following criteria:
- HbA1c ≥ 7.5% and ≤ 11.0% at screening (local laboratory); HbA1c ≥ 7.0% and ≤ 10.5% (central laboratory) prior to randomization(V3);
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- Fasting plasma glucose (FPG) must meet the following criteria:
- FPG < 15 mmol/l at screening (local laboratory); FPG < 15 mmol/l (central laboratory) prior to randomization (V3);
- Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 40.0 kg/m2 at screening or prior to randomization (V3);
- Able to understand and willing to sign the written informed consent form (ICF) and follow the protocol.
Who cannot join
- Patients cannot be randomized if they meet any of the following criteria:
- Patients diagnosed with type 1 diabetes mellitus, diabetes due to pancreatic injury, or special type of diabetes due to other diseases (e.g., acromegaly or Cushing's syndrome);
- Fasting C-peptide < 0.8 ng/mL at screening;
- Patients who use other hypoglycemic drugs except metformin, systemic glucocorticoids (except inhalation or topical external use) and growth hormones within eight weeks before screening or prior to randomization;
- Patients who use insulin continuously for more than 14 days within six months before screening or prior to randomization (the time of insulin treatment for gestational diabetes mellitus is not within this limit);
- Patients who receive other glucokinase activators prior to screening or randomization;
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- Patients who have acute diabetic complications such as diabetic ketoacidosis, lactic acidosis or hyperglycemia and hyperglycemic hyperosmolar status within six months before screening or prior to randomization;
- Patients who have severe chronic diabetic complications (such as proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within six months before screening.
- Patients who have two or more episodes of severe hypoglycemia within sixmonths before screening, or who have had severe hypoglycemia prior to randomization since screening;
- Patients who develop any of the following heart diseases within six months before screening or prior to randomization:
- Decompensated cardiac insufficiency (New York Heart Association NYHA Classification of grade III or IV); Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, or coronary artery balloon dilates or coronary stent implantation; Severe arrhythmias (e.g., second- or third-degree atrioventricular block, long QT syndrome, or QTcF > 480 ms); Arrhythmias that require treatment, or other arrhythmias assessed by the investigator as unsuitable for participation in this clinical study;
- Patients whose hypertension symptoms are not effectively controlled at screening or prior to randomization (sitting systolic blood pressure ≥160mmHg and/or sitting diastolic blood pressure ≥ 100mmHg after resting ≥5 minutes);
- Patients who have hemorrhagic stroke or acute ischemic stroke within six months before screening or prior to randomization;
- Patients who have severe kidney disease or estimated glomerular filtration rate eGFR < 60mL/(min 1.73 m2) or in routine urine qualitative proteinuria ≥ (++) or quantitative proteinuria ≥1 g/L at screening or prior to randomization;
- Patients who have a history of acute or chronic pancreatitis at screening or prior to randomization;
- Patients who suffer from any serious gastrointestinal diseases (such as gastroparesis, inflammatory bowel disease, intestinal obstruction) that affect drug absorption within six months before screening or prior to randomization,or undergo gastrointestinal operations that affect drug absorption (such as gastrectomy, gastroenterostomy or enterectomy, etc.);
- Patients who have severe trauma or serious infection that may affect glycaemic control within one month before screening or prior to randomization, such as fracture, pneumonia, etc.;
- Patients with any type of treated or untreated malignancy (whether cured or not) within five years before screening or prior to randomization. However,patients with cured basal cell carcinoma of the skin do not need to be excluded;
- Patients with thyroid dysfunction not controlled by stable drug dosage at screening or with clinically significant thyroid function test abnormalities at screening and requiring medical treatment;
- Patients who have any of the following laboratory abnormalities at screening:
- Human immunodeficiency virus antibody or Treponema pallidum specific antibody positive; Hepatitis C antibody positive; Hepatitis B surface antigen is positive, and the result of hepatitis B virus DNA quantitative test is higher than the lower limit of the test reference range (Note: If the local laboratory cannot carry out quantitative detection of hepatitis B virus, the sample will be sent to the central laboratory.);
- Patients who have any of the following laboratory abnormalities at screening or prior to randomization:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN), or total bilirubin > 1.5×ULN; Hemoglobin < 110 g/L; Fasting triglycerides ≥ 5.7 mmol/L;
- Patients who have any disease at screening or prior to randomization that may cause hemolysis or red blood cell instability affecting HbA1c testing, such as hemolytic anemia;
- Patients who have a history of blood donation, transfusion, or loss of > 400 ml within ninety days before screening or prior to randomization;
- Subject who has participated in any drug or medical device clinical study within three months before screening or prior to randomization (except those who fail in screening or do not receive any test drug);
- Patients who have a prior history of clearly diagnosed psychiatric disorders, unwilling or unable to fully understand and cooperate, or assessed by the investigator as unsuitable for participation in this clinical study;
- Patients who have a prior history of drinking [(>2 units of alcohol per day and >14 units of alcohol per week (one unit of alcohol corresponds to 150mL of wine or 350mL of beer or 50 mL of spirits)] or history of drug abuse;
- Patients who are known to be allergic or intolerant to the test drug or Vildagliptin or its excipients, or who have contraindications;
- Patients who are currently being treated with strong or moderate liver enzyme CYP3A4 inducers;
- Female in pregnancy or lactation period;
- Partners of male subjects or female subjects who plan to become pregnant or who are unable or unwilling to use contraceptive methods approved by the protocol from the signing of the informed consent form to 30 days after the last use of the drug;
- Compliance with metformin or placebo < 80% or > 120% during single-blind run-in period;
- The investigator judges that the subject is unable to comply with the protocol requirements, such as unable to adhere to diet and exercise treatment during the study, unable to take drugs and meals on time according to the protocol requirements, and unable to conduct self-monitoring of blood glucose (SMBG) in time and record;
- Other circumstances that, in the opinion of the investigator, are not appropriate for participation in this clinical study
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality
Linong Ji, MD,PhD
Linong Ji, MD,PhD
About this study
Official title: A Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poor Glycemic Control Via Metformin Hydrochloride Monotherapy
This is a Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients with Poor Glycemic Control via Metformin Hydrochloride Monotherapy
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- PB-201, PB-201 matched placebo, Metformin hydrochloride
- 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.
PB-201Drug
PB-201: 100 mg each time, orally in the morning and evening respectively
PB-201 matched placeboDrug
PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively
Metformin hydrochlorideDrug
The dosage and administration of metformin hydrochloride remain unchanged before screening
| Study group | Role | What they receive |
|---|---|---|
| Test arm | Experimental | Double-blinded treatment period:
PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage
Open-label extended period:
PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage Receives: Drug: PB-201; Drug: Metformin hydrochloride |
| Placebo arm | Placebo comparator | Double-blinded treatment period:
PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively;Basic treatment with stable dose of Glucophage
Open-label extended period:
PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage Receives: Drug: PB-201 matched placebo; Drug: Metformin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change of glycosylated hemoglobin (HbA1c) from baseline to 24 weeks after treatment
Measured: Week 1,Week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start30 May 2022 (estimated)
- Primary completion24 Sep 2024 (estimated)
- Study completion31 Oct 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 Diabetes MellitusStudies 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
- 546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PegBio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326490
- Sponsor's protocol ID
- PB201302
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poor Glycemic Control Via Metformin Hydrochloride Monotherapy
- ClinicalTrials.gov ID
- NCT05326490
- Acronym / sponsor ID
- PB201302
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 546 participants (estimated)
- Lead sponsor
- PegBio Co., Ltd.University, hospital or other
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 24 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 13 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.
This is a Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients with Poor Glycemic Control via Metformin Hydrochloride Monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test arm | Experimental | Drug: PB-201, Drug: Metformin hydrochlorideDouble-blinded treatment period: PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage Open-label extended period: PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage |
| Placebo arm | Placebo comparator | Drug: PB-201 matched placebo, Drug: Metformin hydrochlorideDouble-blinded treatment period: PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively;Basic treatment with stable dose of Glucophage Open-label extended period: PB201 100 mg, one tablet in the morning and one tablet in the evening;Basic treatment with stable dose of Glucophage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must meet all of the following inclusion criteria to be eligible for this study:
- HbA1c ≥ 7.5% and ≤ 11.0% at screening (local laboratory); HbA1c ≥ 7.0% and ≤ 10.5% (central laboratory) prior to randomization(V3);
- FPG < 15 mmol/l at screening (local laboratory); FPG < 15 mmol/l (central laboratory) prior to randomization (V3);
Key exclusion criteria (35 listed)
- Patients cannot be randomized if they meet any of the following criteria:
- Decompensated cardiac insufficiency (New York Heart Association NYHA Classification of grade III or IV); Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, or coronary artery balloon dilates or coronary stent implantation; Severe arrhythmias (e.g., second- or third-degree atrioventricular block, long QT syndrome, or QTcF > 480 ms); Arrhythmias that require treatment, or other arrhythmias assessed by the investigator as unsuitable for participation in this clinical study;
- Human immunodeficiency virus antibody or Treponema pallidum specific antibody positive; Hepatitis C antibody positive; Hepatitis B surface antigen is positive, and the result of hepatitis B virus DNA quantitative test is higher than the lower limit of the test reference range (Note: If the local laboratory cannot carry out quantitative detection of hepatitis B virus, the sample will be sent to the central laboratory.);
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN), or total bilirubin > 1.5×ULN; Hemoglobin < 110 g/L; Fasting triglycerides ≥ 5.7 mmol/L;
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 |
|---|---|---|
| PB-201PB-201: 100 mg each time, orally in the morning and evening respectively | Drug | Test arm |
| PB-201 matched placeboPB-201 matched placebo: One tablet each time, orally in the morning and evening respectively | Drug | Placebo arm |
| Metformin hydrochlorideThe dosage and administration of metformin hydrochloride remain unchanged before screening | Drug | Placebo arm, Test arm |
Primary outcome
Change in HbA1c
Time frame: Week 1,Week 25
Change of glycosylated hemoglobin (HbA1c) from baseline to 24 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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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.
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 PB-201 and Metformin hydrochloride in people with Type 2 Diabetes Mellitus, run by PegBio 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 10 inclusion and 35 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 22 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 Ying Du, MD,PhD (+8618911797119, ying.du@pegbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Week 1,Week 25). 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 22 Apr 2022.