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

Type2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973515
• Other study ID #: PB-201
• Status: Completed
• Phase: Phase 1
• Start date: August 27, 2019
• Est. completion date: December 19, 2019

Study information

• Verified date: June 2019
• Source: PegBio Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 19, 2019
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Drug:
• glucokinase activator
PB-201 is a kind of dual and partial GKA
• Placebo
Placebo oral tablet

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
PegBio Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to peak(Tmax)	hour	9 days
Primary	Peak Plasma Concentration (Cmax)	ng/mL	9 days
Primary	Area under the plasma concentration versus time curve (AUC)	ng•hr/mL	9 days
Secondary	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	8days
Secondary	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	8 days
Secondary	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	8 days
Secondary	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	8 days