Study to Evaluate the Safety and Efficacy of PB-201 in Treatment-naive Patients With Type 2 Diabetes Mellitus

February 7, 2022 updated by: PegBio Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
672

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • The Second People's Hospital of Hefei
        • Contact:
          • Wu Dai
      • Lu'an, Anhui, China
        • Not yet recruiting
        • Lu'an People's Hospital
        • Contact:
          • Qi Wang
    • Beijing
      • Beijing, Beijing, China
        • Not yet recruiting
        • Peking University People's Hospital
        • Contact:
          • Linong Ji
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Friendship hospital, Capital Medical University
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Pinggu Hospital
        • Contact:
          • Yufeng Li
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Tsinghua Changgung Hospital
      • Beijing, Beijing, China
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Xinhua Xiao
      • Beijing, Beijing, China
        • Not yet recruiting
        • Peking University First Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • Not yet recruiting
        • Chongqing University Three Gorges Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • Not yet recruiting
        • Lanzhou University Second Hospital
        • Contact:
          • Jiangong Ren
    • Guangdong
      • Huizhou, Guangdong, China
        • Not yet recruiting
        • Huizhou Municipal Central Hospital
        • Contact:
          • Shu Li
    • Hebei
      • Cangzhou, Hebei, China
        • Not yet recruiting
        • Cangzhou People's Hospital
        • Contact:
          • Fang Bian
      • Handan, Hebei, China
        • Not yet recruiting
        • Handan First Hospital
        • Contact:
          • Haifang Wang
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Not yet recruiting
        • The Fourth Hospital of Harbin Medical University
      • Qiqihar, Heilongjiang, China
        • Not yet recruiting
        • The First Hospital of Qiqihar
        • Contact:
          • Xuhong Wang
    • Henan
      • Kai Feng, Henan, China
        • Not yet recruiting
        • Huaihe Hospital of Henan University
      • Luoyang, Henan, China
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Yujin Ma
    • Hubei
      • Shiyan, Hubei, China
        • Not yet recruiting
        • Shiyan Renmin Hospital
        • Contact:
          • Hongcheng Ding
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • The Third Hospital of Changsha
        • Contact:
          • Debin Huang
      • Chenzhou, Hunan, China
        • Not yet recruiting
        • Chenzhou No.1 people's Hospital
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Not yet recruiting
        • Inner Mongolia Baogang Hospital
        • Contact:
          • Ziling Li
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Nanjing First Hospital
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Nanjing Jiangning Hospital
        • Contact:
          • Kun Wang
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Sir Run Run Hospital Nanjing Medical Universtiy
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
      • Nantong, Jiangsu, China
        • Not yet recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
          • Yunjuan Gu
      • Nantong, Jiangsu, China
        • Not yet recruiting
        • Nantong First People's Hospital
        • Contact:
          • Xueqin Wang
    • Jiangxi
      • Pingxiang, Jiangxi, China
        • Not yet recruiting
        • Jiangxi Pingxiang People's Hospital
        • Contact:
          • Yawei Zhang
    • Jilin
      • Changchun, Jilin, China
        • Not yet recruiting
        • The Second Hospital of Jilin University
    • Liaoning
      • Panjin, Liaoning, China
        • Not yet recruiting
        • Panjin LiaoHe Oil Field Gem Flower Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Not yet recruiting
        • Tangdu Hospital, Air Force Medical University
        • Contact:
          • Bin Gao
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Jinan Central Hospital
      • Qingdao, Shandong, China
        • Not yet recruiting
        • Qingdao Central Hospital
        • Contact:
          • Minxiu Yao
    • Shanxi
      • Changzhi, Shanxi, China
        • Not yet recruiting
        • Peace Hospital Affiliated to Changzhi Medical College
        • Contact:
          • Huwei Shen
      • Datong, Shanxi, China
        • Not yet recruiting
        • The Third People's Hospital of Datong
        • Contact:
          • Yan Liu
      • Ya'an, Shanxi, China
        • Not yet recruiting
        • Yan'an University Affiliated Hospital
        • Contact:
          • Sheli Li
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • Chengdu Fifth People's Hospital
        • Contact:
          • Hongyi Cao
    • Zhejiang
      • Huzhou, Zhejiang, China
        • Not yet recruiting
        • Huzhou Central Hospital
        • Contact:
          • Xiaohui Zhou
      • Jiaxing, Zhejiang, China
        • Recruiting
        • Jiaxing Second Hospital
        • Contact:
          • Pengfei Du
  • Hong Kong
      • Hong Kong, Hong Kong
        • Not yet recruiting
        • The Chinese University of Hong Kong, Prince of Wales Hospital
        • Contact:
          • Elaine Chow
      • Hong Kong, Hong Kong
        • Not yet recruiting
        • The University of Hong Kong, Queen Mary Hospital
        • Contact:
          • Wing Sun Chow
  • Taiwan
      • Taipei, Taiwan
        • Not yet recruiting
        • National Taiwan University Hospital
        • Contact:
          • Kuo-Chin Huang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

    1. HbA1c ≥ 7.5% and ≤ 11.0% at screening (local laboratory);
    2. 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.

Exclusion Criteria:

  • 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 ;
  • 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:

    1. Human immunodeficiency virus antibody or Treponema pallidum specific antibody positive;
    2. Hepatitis C antibody positive;
    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test arm
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;
Drug: PB-201
PB-201: 100 mg each time, orally in the morning and evening respectively;
Drug: Vildagliptin matched placebo
One tablet each time, orally in the morning and evening respectively;
Active Comparator: Vildagliptin arm
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;
Drug: Vildagliptin
Vildagliptin: 50 mg each time, orally in the morning and evening respectively;
Drug: PB-201 matched placebo
PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively;
Placebo Comparator: Placebo arm
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;
Drug: Vildagliptin matched placebo
One tablet each time, orally in the morning and evening respectively;
Drug: PB-201 matched placebo
PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively;

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: Week 1,Week 25
Change from baseline in HbA1c after 24 weeks of treatment
Week 1,Week 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PegBio Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linong Ji, MD,PhD, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PB201303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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