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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05102149
Recruitment Status : Recruiting
First Posted : November 1, 2021
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
PegBio Co., Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus (T2DM) Drug: PB-201 Drug: Vildagliptin Drug: PB-201 matched placebo Drug: Vildagliptin matched placebo Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 30, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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: PB-201 matched placebo
PB-201 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;


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Week 1,Week 25 ]
    Change from baseline in HbA1c after 24 weeks of treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05102149


Contacts
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Contact: Ying Du, MD,PhD +86-18911797119 ying.du@pegbio.com
Contact: Michael Xu, MD,PhD +86-512-62956129 michael.xu@pegbio.com

Locations
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Sponsors and Collaborators
PegBio Co., Ltd.
Investigators
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Principal Investigator: Linong Ji, MD,PhD Peking University People's Hospital
More Information
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Responsible Party: PegBio Co., Ltd.
ClinicalTrials.gov Identifier: NCT05102149    
Other Study ID Numbers: PB201303
First Posted: November 1, 2021    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
 Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action