Type 2 Diabetes Mellitus (T2DM)Phase 3NCT05102149
Study to Evaluate the Safety and Efficacy of PB-201 in Treatment-naive Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing PB-201 and Vildagliptin in people with Type 2 Diabetes Mellitus (T2DM), run by PegBio Co., Ltd. at 42 sites in 3 countries.
Trial summary
This is a multicenter, randomized, double-blind, parallel, Vildagliptin and Placebo-Controlled study to evaluate the efficacy and safety of oral administration of 100 mg of PB-201 in the morning and evening in treatmentnaive patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- PB-201 and Vildagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 672 participants
- Where
- 42 sitesin 3 countries
- Study dates
- 30 Sep 2021to Apr 2025
- 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;
- Diagnosed T2DM patients who meet the diagnostic criteria for type 2 diabetes mellitus issued by WHO in 1999 (see Appendix 2 for diagnostic criteria of type 2 diabetes mellitus);
- Receive diet and exercise interventions for at least eight weeks before screening and do not receive any anti-diabetes medications within eight weeks before screening;
- The Glycosylated hemoglobin (HbA1c) must meet the following criteria:
- HbA1c ≥ 7.5% and ≤ 11.0% at screening (local laboratory);
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- HbA1c ≥ 7.0% and ≤ 10.5% (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);
- Patients who receive other glucokinase activators prior to screening or randomization;
- 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 six months before screening, or who have had severe hypoglycemia prior to randomization since screening ;
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- Patients who have hemorrhagic stroke or acute ischemic stroke within six months before 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 have underwent 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 bone 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 abnormalities of thyroid function test with clinically significant 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 disease at screening or prior to randomization that may cause hemolysis or red blood cell instability affecting HbA1c testing, such as hemolytic anemia;
- 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 trial 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 grape 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 their excipients, or who have contraindications;
- Patients who have refractory urinary or genital infections within six months before screening, or are known to be allergic to Empagliflozin or its excipients;
- 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 required by the protocol from the signing of the informed consent form to 30 days after the last dose of the drug;
- 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
42 sites in 3 countries.
42 sites in 3 countries
China39 sites, 39 recruiting
- Not yet recruiting
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia
Ziling Li
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Mingxia Yuan
- Not yet recruiting
Beijing Pinggu Hospital
Beijing, Beijing Municipality
Yufeng Li
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality
Jianzhong Xiao
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Xinhua Xiao
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Junqing Zhang
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Linong Ji
- Not yet recruiting
Cangzhou People's Hospital
Cangzhou, Hebei
Fang Bian
- Not yet recruiting
The Second Hospital of Jilin University
Changchun, Jilin
Hanqing Cai
- Not yet recruiting
The Third Hospital of Changsha
Changsha, Hunan
Debin Huang
- Not yet recruiting
Peace Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi
Huwei Shen
- Not yet recruiting
Chengdu Fifth People's Hospital
Chengdu, Sichuan
Hongyi Cao
- Not yet recruiting
Chenzhou No.1 People's Hospital
Chenzhou, Hunan
Weihong Song
- Not yet recruiting
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality
Weijuan Liu
- Not yet recruiting
The Third People's Hospital of Datong
Datong, Shanxi
Yan Liu
- Not yet recruiting
Handan First Hospital
Handan, Hebei
Haifang Wang
- Not yet recruiting
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang
Zhifeng Cheng
- Not yet recruiting
The Second People's Hospital of Hefei
Hefei, Anhui
Wu Dai
- Not yet recruiting
Huizhou Municipal Central Hospital
Huizhou, Guangdong
Shu Li
- Not yet recruiting
Huzhou Central Hospital
Huzhou, Zhejiang
Xiaohui Zhou
- Recruiting
Jiaxing Second Hospital
Jiaxing, Zhejiang
Pengfei Du
- Not yet recruiting
Jinan Central Hospital
Jinan, Shandong
Xiaolin Dong
- Not yet recruiting
Huaihe Hospital of Henan University
Kaifeng, Henan
Wuyan Pang
- Not yet recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu
Jiangong Ren
- Not yet recruiting
Lu'an People's Hospital
Lu'an, Anhui
Qi Wang
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Yujin Ma
- Not yet recruiting
Nanjing First Hospital
Nanjing, Jiangsu
Jianhua Ma
- Not yet recruiting
Nanjing Jiangning Hospital
Nanjing, Jiangsu
Kun Wang
- Not yet recruiting
Sir Run Run Hospital Nanjing Medical Universtiy
Nanjing, Jiangsu
Yu Liu
- Not yet recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Yibing Lu
- Not yet recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Yunjuan Gu
- Not yet recruiting
Nantong First People's Hospital
Nantong, Jiangsu
Xueqin Wang
- Not yet recruiting
Panjin LiaoHe Oil Field Gem Flower Hospital
Panjin, Liaoning
Xin Zhang
- Not yet recruiting
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi
Yawei Zhang
- Not yet recruiting
Qingdao Central Hospital
Qingdao, Shandong
Minxiu Yao
- Not yet recruiting
The First Hospital of Qiqihar
Qiqihar, Heilongjiang
Xuhong Wang
- Not yet recruiting
Shiyan Renmin Hospital
Shiyan, Hubei
Hongcheng Ding
- Not yet recruiting
Tangdu Hospital, Air Force Medical University
Xi'an, Shaanxi
Bin Gao
- Not yet recruiting
Yan'an University Affiliated Hospital
Ya'an, Shanxi
Sheli Li
Hong Kong2 sites, 2 recruiting
- Not yet recruiting
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong
Elaine Chow
- Not yet recruiting
The University of Hong Kong, Queen Mary Hospital
Hong Kong
Wing Sun Chow
Taiwan1 site, 1 recruiting
- Not yet recruiting
National Taiwan University Hospital
Taipei
Kuo-Chin Huang
About this study
Official title: A Multi-center, Randomized, Double-Blinded, Parallel, Vildagliptin and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Treatment-naive Patients With Type 2 Diabetes Mellitus
This is a multicenter, randomized, double-blind, parallel, Vildagliptin and Placebo-Controlled study to evaluate the efficacy and safety of oral administration of 100 mg of PB-201 in the morning and evening in treatmentnaive patients with type 2 diabetes mellitus.
Read the detailed description
The study consists of a screening period of up to 2 weeks, a 4-week single-blind run-in period, a 24-week double-blinded treatment period, a 28-week extended treatment period, and a 2-week safety follow-up period.Eligible subjects will be enrolled in a 4-week single-blind run-in period with daily oral administration of 1 tablet of PB-201 matched placebo and 1 Vildagliptin matched placebo in the morning and evening respectively.After the end of the single-blind run-in period, subjects who meet the protocol enrollment requirements will be randomized in the proportion of 2:1:1 to receive double-blinded treatment for 24 weeks in three different treatment groups (test arm, Vildagliptin arm, or placebo arm).
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- PB-201, Vildagliptin, PB-201 matched placebo, Vildagliptin matched placebo
- 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;
VildagliptinDrug
Vildagliptin: 50 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;
Vildagliptin matched placeboDrug
One tablet each time, orally in the morning and evening respectively;
| Study group | Role | What they receive |
|---|---|---|
| Test arm | Experimental | PB-201: 100 mg each time, orally in the morning and evening respectively; Vildagliptin matched placebo: One tablet each time, orally in the morning and evening respectively; Receives: Drug: PB-201; Drug: Vildagliptin matched placebo |
| Vildagliptin arm | Active comparator | Vildagliptin: 50 mg each time, orally in the morning and evening respectively; PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively; Receives: Drug: Vildagliptin; Drug: PB-201 matched placebo |
| Placebo arm | Placebo comparator | PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively; Vildagliptin matched placebo: One tablet each time, orally in the morning and evening respectively; Receives: Drug: PB-201 matched placebo; Drug: Vildagliptin matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change from baseline in HbA1c after 24 weeks of 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 posted1 Nov 2021
- Study start30 Sep 2021
- Primary completionNov 2023 (estimated)
- Study completionApr 2025 (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 Mellitus (T2DM)Studies 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
- 672 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PegBio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linong Ji, MD,PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102149
- Sponsor's protocol ID
- PB201303
- Status last verified
- Feb 2022
- First submitted
- 20 Oct 2021
- Last updated
- 8 Feb 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 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blinded, Parallel, Vildagliptin and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Treatment-naive Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05102149
- Acronym / sponsor ID
- PB201303
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 672 participants (estimated)
- Lead sponsor
- PegBio Co., Ltd.University, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 1 Nov 2021 (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 multicenter, randomized, double-blind, parallel, Vildagliptin and Placebo-Controlled study to evaluate the efficacy and safety of oral administration of 100 mg of PB-201 in the morning and evening in treatmentnaive patients with type 2 diabetes mellitus.
Detailed description
The study consists of a screening period of up to 2 weeks, a 4-week single-blind run-in period, a 24-week double-blinded treatment period, a 28-week extended treatment period, and a 2-week safety follow-up period.Eligible subjects will be enrolled in a 4-week single-blind run-in period with daily oral administration of 1 tablet of PB-201 matched placebo and 1 Vildagliptin matched placebo in the morning and evening respectively.After the end of the single-blind run-in period, subjects who meet the protocol enrollment requirements will be randomized in the proportion of 2:1:1 to receive double-blinded treatment for 24 weeks in three different treatment groups (test arm, Vildagliptin arm, or placebo arm).
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 |
|---|---|---|
| Test arm | Experimental | Drug: PB-201, Drug: Vildagliptin matched placeboPB-201: 100 mg each time, orally in the morning and evening respectively; Vildagliptin matched placebo: One tablet each time, orally in the morning and evening respectively; |
| Vildagliptin arm | Active comparator | Drug: Vildagliptin, Drug: PB-201 matched placeboVildagliptin: 50 mg each time, orally in the morning and evening respectively; PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively; |
| Placebo arm | Placebo comparator | Drug: PB-201 matched placebo, Drug: Vildagliptin matched placeboPB-201 matched placebo: One tablet each time, orally in the morning and evening respectively; Vildagliptin matched placebo: One tablet each time, orally in the morning and evening respectively; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
- Diagnosed T2DM patients who meet the diagnostic criteria for type 2 diabetes mellitus issued by WHO in 1999 (see Appendix 2 for diagnostic criteria of type 2 diabetes mellitus);
- Receive diet and exercise interventions for at least eight weeks before screening and do not receive any anti-diabetes medications within eight weeks before screening;
- The Glycosylated hemoglobin (HbA1c) must meet the following criteria:
Key exclusion criteria (26 listed)
- 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);
- Patients who receive other glucokinase activators prior to screening or randomization;
- 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.
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 |
| VildagliptinVildagliptin: 50 mg each time, orally in the morning and evening respectively; | Drug | Vildagliptin arm |
| PB-201 matched placeboPB-201 matched placebo: One tablet each time, orally in the morning and evening respectively; | Drug | Placebo arm, Vildagliptin arm |
| Vildagliptin matched placeboOne tablet each time, orally in the morning and evening respectively; | Drug | Placebo arm, Test arm |
Primary outcome
Change in HbA1c
Time frame: Week 1,Week 25
Change from baseline in HbA1c after 24 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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.
Linong Ji, MD,PhD principal investigator
Peking University People's Hospital
42 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PB-201 and Vildagliptin in people with Type 2 Diabetes Mellitus (T2DM), run by PegBio Co., Ltd. at 42 sites in 3 countries.
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 9 inclusion and 26 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 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in China, Hong Kong, Taiwan. 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 (+86-18911797119, 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 8 Feb 2022.