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

PegBio

Status and phase: Completed; Phase 1

Conditions: Type2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: glucokinase activator

Study type: Interventional

Funder types: Other

Identifiers

NCT03973515

PB-201

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 4 patient groups, including a placebo group

PB-201 50/50mg by mouth,every morning and noon for 7 days

Experimental group

Treatment:

Drug: glucokinase activator

PB-201 100/50mg by mouth,every morning and noon for 7 days

Experimental group

Treatment:

Drug: glucokinase activator

PB-201 100/100mg by mouth,every morning and noon for 7 days

Experimental group

Treatment:

Drug: glucokinase activator

placebo

Placebo Comparator group

Treatment:

Drug: Placebo