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Completed

NCT Number: NCT03973515

Clinical Trial for the Investigational Drug (PB-201) in Subjects With Type 2 Diabetes Mellitus

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.

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Key information

Conditions

Type2 Diabetes Mellitus Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes
  • History of febrile illness within 5 days prior to dosing
  • Medical history of myocardial infarction, angina/unstable angina, coronary revascularization, stroke or transient ischemic attack
  • Any medical history or current clinical evidence of congestive heart failure, New York Heart Association (NYHA) Functional Classification, Classes II-IV
  • Episode(s) of hypoglycemia adverse events (HAE) of 'severe' intensity prior to screening; either:
  • >1 in the previous 3 months; or
  • >2 in the previous 6 months

Treatment and study plan

glucokinase activator

Drug

PB-201 is a kind of dual and partial GKA

Other names: PB-201

Placebo

Drug

Placebo oral tablet

Other names: PB-201 Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

PegBio Co., Ltd.

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 4, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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