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

PegBio Co., Ltd.16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type2 Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to peak(Tmax)

hour

Time frame: 9 days

Peak Plasma Concentration (Cmax)

ng/mL

Time frame: 9 days

Area under the plasma concentration versus time curve (AUC)

ng•hr/mL

Time frame: 9 days

Secondary Outcomes

The change for fasting plasma glucose (FPG)

The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo

Time frame: 8days

The change for postprandial plasma glucose (PPG)

The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo

Time frame: 8 days

The change for plasma C-peptide

The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo

Time frame: 8 days

The change for plasma insulin

The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo

Time frame: 8 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes