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

Phase 1

Completed

• Conditions: Type2 Diabetes Mellitus
• Interventions: Drug: glucokinase activator; Drug: Placebo

• Registration Number: NCT03973515
• Lead Sponsor: PegBio Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-29
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-02
• Study First Posted: 2019-06-04
• Study Start: 2019-08-27
• Primary Completion: 2019-12-19
• Study Completion: 2019-12-19
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PB-201 50/50mg by mouth,every morning and noon for 7 days	glucokinase activator	-
PB-201 100/100mg by mouth,every morning and noon for 7 days	glucokinase activator	-
PB-201 100/50mg by mouth,every morning and noon for 7 days	glucokinase activator	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time to peak(Tmax)	9 days	hour
Peak Plasma Concentration (Cmax)	9 days	ng/mL
Area under the plasma concentration versus time curve (AUC)	9 days	ng•hr/mL

Secondary Outcome Measures

Name	Time	Method
The change for plasma insulin	8 days	The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo
The change for fasting plasma glucose (FPG)	8days	The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo
The change for postprandial plasma glucose (PPG)	8 days	The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo
The change for plasma C-peptide	8 days	The change from baseline value (day 0) to the last dose of drug in this period (day 7) compared to placebo

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China