Type2 Diabetes MellitusPhase 1NCT03973515
Clinical Trial for the Investigational Drug (PB-201) in Subjects With Type 2 Diabetes Mellitus
A Phase 1 study testing glucokinase activator in people with Type2 Diabetes Mellitus, run by PegBio Co., Ltd. at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- glucokinase activator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2019to 19 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glycosylated hemoglobin (HbA1c) 7.5%-11% at screening, and 7.0%-10.0% pre-randomization
- FPG 7.0 mmol/L-11.0mmol/L at screening and pre-randomization
- Body mass index (BMI) 18.5 and-35.0 kg/m2 at screening
- Antidiabetics-naive within 2 months before screening
Who cannot join
- Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes
- History of febrile illness within 5 days prior to dosing
- Medical history of myocardial infarction, angina/unstable angina, coronary revascularization, stroke or transient ischemic attack
- Any medical history or current clinical evidence of congestive heart failure, New York Heart Association (NYHA) Functional Classification, Classes II-IV
- Episode(s) of hypoglycemia adverse events (HAE) of 'severe' intensity prior to screening; either:
- >1 in the previous 3 months; or
- >2 in the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- glucokinase activator, Placebo
- Keywords
- Glucokinase activator(GKA), hypoglycemia
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucokinase activatorDrug
Also called PB-201
PB-201 is a kind of dual and partial GKA
PlaceboDrug
Also called PB-201 Placebo
Placebo oral tablet
| Study group | Role | What they receive |
|---|---|---|
| PB-201 50/50mg by mouth,every morning and noon for 7 days | Experimental | Not described Receives: Drug: glucokinase activator |
| PB-201 100/50mg by mouth,every morning and noon for 7 days | Experimental | Not described Receives: Drug: glucokinase activator |
| PB-201 100/100mg by mouth,every morning and noon for 7 days | Experimental | Not described Receives: Drug: glucokinase activator |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to peak(Tmax)
hour
Measured: 9 days
Peak Plasma Concentration (Cmax)
ng/mL
Measured: 9 days
Area under the plasma concentration versus time curve (AUC)
ng•hr/mL
Measured: 9 days
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start27 Aug 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- PegBio Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HaiYan Li, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973515
- Sponsor's protocol ID
- PB-201
- Status last verified
- Jun 2019
- First submitted
- 29 May 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34805810
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03973515
- Acronym / sponsor ID
- PB-201
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- Glucokinase activator(GKA), hypoglycemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PegBio Co., Ltd.University, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PB-201 50/50mg by mouth,every morning and noon for 7 days | Experimental | Drug: glucokinase activator |
| PB-201 100/50mg by mouth,every morning and noon for 7 days | Experimental | Drug: glucokinase activator |
| PB-201 100/100mg by mouth,every morning and noon for 7 days | Experimental | Drug: glucokinase activator |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Glycosylated hemoglobin (HbA1c) 7.5%-11% at screening, and 7.0%-10.0% pre-randomization
- FPG 7.0 mmol/L-11.0mmol/L at screening and pre-randomization
- Body mass index (BMI) 18.5 and-35.0 kg/m2 at screening
- Antidiabetics-naive within 2 months before screening
Key exclusion criteria (7 listed)
- Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes
- History of febrile illness within 5 days prior to dosing
- Medical history of myocardial infarction, angina/unstable angina, coronary revascularization, stroke or transient ischemic attack
- Any medical history or current clinical evidence of congestive heart failure, New York Heart Association (NYHA) Functional Classification, Classes II-IV
- Episode(s) of hypoglycemia adverse events (HAE) of 'severe' intensity prior to screening; either:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucokinase activatorAlso: PB-201PB-201 is a kind of dual and partial GKA | Drug | PB-201 100/100mg by mouth,every morning and noon for 7 days, PB-201 100/50mg by mouth,every morning and noon for 7 days, PB-201 50/50mg by mouth,every morning and noon for 7 days |
| PlaceboAlso: PB-201 PlaceboPlacebo oral tablet | Drug | placebo |
Primary outcome
Time to peak(Tmax)
Time frame: 9 days
hour
Peak Plasma Concentration (Cmax)
Time frame: 9 days
ng/mL
Area under the plasma concentration versus time curve (AUC)
Time frame: 9 days
ng•hr/mL
4 secondary outcomes
The change for fasting plasma glucose (FPG)
Time frame: 8days
The change for postprandial plasma glucose (PPG)
Time frame: 8 days
The change for plasma C-peptide
Time frame: 8 days
The change for plasma insulin
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 34805810Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HaiYan Li principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing glucokinase activator in people with Type2 Diabetes Mellitus, run by PegBio Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to peak(Tmax) (time frame: 9 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.