Clinical Trial for the Investigational Drug (PB-201) in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT03973515
Last Updated: 2020-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2019-08-27
2019-12-19
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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PB-201 50/50mg by mouth,every morning and noon for 7 days
glucokinase activator
PB-201 is a kind of dual and partial GKA
PB-201 100/50mg by mouth,every morning and noon for 7 days
glucokinase activator
PB-201 is a kind of dual and partial GKA
PB-201 100/100mg by mouth,every morning and noon for 7 days
glucokinase activator
PB-201 is a kind of dual and partial GKA
placebo
Placebo
Placebo oral tablet
Interventions
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glucokinase activator
PB-201 is a kind of dual and partial GKA
Placebo
Placebo oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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PegBio Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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HaiYan Li
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, , China
Countries
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References
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Liu D, Du Y, Yao X, Wei Y, Zhu J, Cui C, Zhou H, Xu M, Li H, Ji L. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the glucokinase activator PB-201 and its effects on the glucose excursion profile in drug-naive Chinese patients with type 2 diabetes: a randomised controlled, crossover, single-centre phase 1 trial. EClinicalMedicine. 2021 Nov 6;42:101185. doi: 10.1016/j.eclinm.2021.101185. eCollection 2021 Dec.
Other Identifiers
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PB-201
Identifier Type: -
Identifier Source: org_study_id
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