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Clinical Trial for the Investigational Drug (PB-201) in Subjects 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03973515
Recruitment Status : Completed
First Posted : June 4, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
PegBio Co., Ltd.

Study Description
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Brief Summary:

This crossover study investigates the safety, tolerability, pharmacokinetics (PK) ,pharmacodynamics (PD) effect of three dose levels of PB-201,and characterizes the PK profile of a prominent des-methyl metabolite of PB-201(WI-0800), following dosing of three dose levels of PB-201 in drug-naive Chinese adult subjects with Type 2 diabetes mellitus (T2DM) as monotherapy.

There were 7 days separating 4 treatment periods and at least 7-day washout (but not exceeding 14 days) between dosing in 4 periods with 3 dose levels of PB-201 and placebo. Three dose levels of PB-201 are: split dose regimen of 50 mg 30 minutes before morning meal plus 50 mg 30 minutes before lunch at approximately 3.5 hours after morning dose, and split dose regimen of 100 mg 30 minutes before morning meal plus 100 mg 30 minutes before lunch at approximately 3.5 hours after morning dose, and split dose regimen of 150 mg 30 minutes before morning meal plus 100 mg 30 minutes before lunch at approximately 3.5 hours after morning dose.


Condition or disease Intervention/treatment Phase
Type2 Diabetes Mellitus Drug: glucokinase activator Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 4-Period, Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Three Dose Levels of the Investigational Drug (PB-201) in Drug-naive Adult Subjects With Type 2 Diabetes Mellitus as Monotherapy
Actual Study Start Date : August 27, 2019
Actual Primary Completion Date : December 19, 2019
Actual Study Completion Date : December 19, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PB-201 50/50mg by mouth,every morning and noon for 7 days Drug: glucokinase activator
PB-201 is a kind of dual and partial GKA
Other Name: PB-201
Experimental: PB-201 100/50mg by mouth,every morning and noon for 7 days Drug: glucokinase activator
PB-201 is a kind of dual and partial GKA
Other Name: PB-201
Experimental: PB-201 100/100mg by mouth,every morning and noon for 7 days Drug: glucokinase activator
PB-201 is a kind of dual and partial GKA
Other Name: PB-201
Placebo Comparator: placebo Drug: Placebo
Placebo oral tablet
Other Name: PB-201 Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Time to peak(Tmax) [ Time Frame: 9 days ]
    hour

  2. Peak Plasma Concentration (Cmax) [ Time Frame: 9 days ]
    ng/mL

  3. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 9 days ]
    ng•hr/mL


Secondary Outcome Measures :
  1. The change for fasting plasma glucose (FPG) [ Time Frame: 8days ]
    The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo

  2. The change for postprandial plasma glucose (PPG) [ Time Frame: 8 days ]
    The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo

  3. The change for plasma C-peptide [ Time Frame: 8 days ]
    The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo

  4. The change for plasma insulin [ Time Frame: 8 days ]
    The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Glycosylated hemoglobin (HbA1c) 7.5%-11% at screening, and 7.0%-10.0% pre-randomization
  2. FPG 7.0 mmol/L-11.0mmol/L at screening and pre-randomization
  3. Body mass index (BMI) 18.5 and-35.0 kg/m2 at screening
  4. Antidiabetics-naive within 2 months before screening

Exclusion Criteria:

  1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes
  2. History of febrile illness within 5 days prior to dosing
  3. Medical history of myocardial infarction, angina/unstable angina, coronary revascularization, stroke or transient ischemic attack
  4. Any medical history or current clinical evidence of congestive heart failure, New York Heart Association (NYHA) Functional Classification, Classes II-IV

  5. Episode(s) of hypoglycemia adverse events (HAE) of 'severe' intensity prior to screening; either:

    1. >1 in the previous 3 months; or
    2. >2 in the previous 6 months
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): NCT03973515


Locations
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China
Peking University Third Hospital
Beijing, China
Sponsors and Collaborators
PegBio Co., Ltd.
Investigators
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Principal Investigator: HaiYan Li Peking University Third Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PegBio Co., Ltd.
ClinicalTrials.gov Identifier: NCT03973515    
Other Study ID Numbers: PB-201
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: June 2019
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
Keywords provided by PegBio Co., Ltd.:
Glucokinase activator(GKA)
hypoglycemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases