Type 2 DiabetesPhase 2NCT05248776
Efficacy, Safety and Pharmacokinetics Study of CPL207280 After 2-weeks Administration in Subjects With Type 2 Diabetes
A Phase 2 study testing CPL207280 in people with Type 2 Diabetes, run by Celon Pharma SA at 1 site in Poland.
Trial summary
The planned study is to evaluate the efficacy, safety and pharmacokinetic (PK) properties of CPL207280 after multiple (14 days) administration in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CPL207280
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 21 Jan 2022to 30 Jun 2023
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant with type 2 diabetes who are newly diagnosed (no longer than 3 years before the study) managed with diet and exercise alone, or who failed to achieve adequate glycemic control on a stable dose of metformin and willing to discontinue it at least 10 days prior to randomization and during the study.
- Participant has fasting plasma glucose level less than or equal 180 mg/dL.
- Participant has calculated homeostasis model assessment for insulin resistance (HOMA-IR) value less than or equal to 7.
- Participant has body-mass index (BMI): ≥ 18.50 kg/m² and ≤ 40.00 kg/m².
- Participant should have a HbA1c concentration greater than or equal to 6.0% and less than or equal to 8.0%.
- Participant has not received treatment with weight-loss drugs within the 3 months prior to the study
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- Participant has a systolic blood pressure less than or equal to 160 mm Hg and a diastolic blood pressure of less than or equal to 100 mm Hg.
- Participant has the clinical laboratory evaluations [including fasting clinical chemistry, hematology and complete urinalysis (excluding glucose results)] within the reference range for the testing laboratory, unless the investigator deems the out-of-range results to be not clinically significant.
- Participant has negative test results for hepatitis B surface antigen and antibody to hepatitis C virus, negative RT-PCR test results for COVID-19, negative antibody to HIV virus and no known history of human immunodeficiency virus.
- Participant is considered by the investigator to be in a good health (other than being diabetic) as determined during the medical history review, physical examination findings, electrocardiogram and vital sign results, and clinical laboratory evaluations.
- Participant has estimated Glomerular Filtration Rate (eGFR) greater than 60 mL/min/1.73m^2.
- A female is eligible to participate if she is not pregnant (negative serum pregnancy test ), not breastfeeding,
- Male participants must agree to use a barrier method of contraceptive during the study and for at least 90 days after the last dose of the study drug
- Participant has the ability and willingness to comply with the requirements and restrictions of the study protocol.
Who cannot join
- Participant has a c-peptide value less than 0.5 nmol/l.
- Participant has a history of abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy), thoracic, or non-peripheral vascular surgery within 6 months prior to the study.
- Participant has a history of cardiac arrhythmia, systolic dysfunction, congestive heart failure, angina, myocardial ischemia or infarction, or stroke within 1 year prior to the study, or the presence of an abnormal ECG that, in the investigator's opinion, is clinically significant.
- Participant has a history of drug abuse or a history of alcohol abuse within 2 years prior to the study.
- Participant has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. This criterion does not apply to basal cell or stage I squamous cell carcinoma of the skin.
- Participant has an alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase level above normal range for the testing laboratory, active liver disease.
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- Participant has a total bilirubin greater or equal 2 mg/dL.
- Participant is/ was lifetime on any insulin treatment or takes other diabetes treatment (except metformin).
- Participant has a history of proteinuria ≥300 mg/day on a 12- or 24-hour urine collection within last year or an albumin/creatinine ratio greater or equal 300 μg/mg.
- Participant has a history of any clinically significant retinopathy, which is defined as more than moderate nonproliferative diabetic retinopathy, any stage of proliferative diabetic retinopathy or any history of laser-treated retinopathy.
- Participant has clinically significant peripheral or autonomic neuropathy.
- Participant has a lifetime history of ulcerative colitis or Crohn's disease, or has undergone gastric resection.
- Participant has a history of a psychiatric disorder that, in Principal Investigator opinion, will affect the subject ability to participate in the study.
- Participant has a lifetime history of angioedema.
- Participant has an acute, clinically significant illness within 30 days prior to the study or any other condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study.
- Participant is not able to comply with the study scheduled visits.
- Participant is participating in another investigational study or has taken any investigational drug within 90 days prior to the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
BioResearch
Kajetany, Nadarzyn, 05-830
Katarzyna z Jarus-Dziedzic, MD, PhD, +48 22 112195152, rekrutacja@bioresearch.pl
Małgorzata Jonak, MD
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety and Pharmacokinetics After 2-weeks Administration of CPL207280 (GPR40 Agonist) in Subjects With Type 2 Diabetes (T2D)
The planned study is to evaluate the efficacy, safety and pharmacokinetic (PK) properties of CPL207280 after multiple (14 days) administration in patients with type 2 diabetes.
Read the detailed description
A double-blind, randomized, placebo-controlled, parallel-group study of 4 different doses of CPL207280 administered orally for 14 days. Approximately 80 participants will be randomized at a 1:1:1:1:1 ratio to 5 arms to receive Investigational Medicinal Product (IMP) or placebo.
- Conditions
- Type 2 Diabetes
- Being tested
- CPL207280, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPL207280Drug
IMP is a tablet with CPL207280 as an Active Pharmaceutical Ingredient (API).
PlaceboDrug
Matching placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| CPL207280 60 mg | Experimental | 16 participants are to receive IMP at dose 60 mg.IMP will be administered for 14 days, every morning, after a minimum 8-hours overnight fast. Participants are to be randomized. Receives: Drug: CPL207280 |
| CPL207280 120 mg | Experimental | 16 participants are to receive IMP at dose 120 mg. IMP will be administered for 14 days, every morning, after a minimum 8-hours overnight fast. Participants are to be randomized. Receives: Drug: CPL207280 |
| CPL207280 240 mg | Experimental | 16 participants are to receive IMP at dose 240 mg. IMP will be administered for 14 days, every morning, after a minimum 8-hours overnight fast. Participants are to be randomized. Receives: Drug: CPL207280 |
| CPL207280 480 mg | Experimental | 16 participants are to receive IMP at dose 480 mg. IMP will be administered for 14 days, every morning, after a minimum 8-hours overnight fast. Participants are to be randomized Receives: Drug: CPL207280 |
| Placebo | Placebo comparator | 16 participants are to receive masking placebo tablets once daily for 14 days, every morning, after a minimum 8-hours overnight fast. Participants are to be randomized Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in lowering plasma glucose during the Oral Glucose Tolerance Test (OGTT) after 2 weeks of CPL207280 treatment
Change in plasma glucose, evaluated through area under the plasma glucose concentration- time curve AUC (0-3 h) during the OGTT.
Measured: Day -2 and Day -14
Secondary outcomes (25)
Change in plasma glucose maximal concentration (Cmax) level during the OGTT
Measured: Day -2 and Day 14
Change in plasma glucose concentration level at 2 hours timepoint level during the OGTT
Measured: Day -2 and Day -14
Change in Fasting Plasma Glucose (FPG)
Measured: Day 1 and Day 15
Change in Fasting Plasma Insulin (FPI)
Measured: Day 1 and Day 15
Change in Fasting Plasma Proinsulin
Measured: Day 1 and Day 15
Change in Fasting Plasma c-peptide
Measured: Day 1 and Day 15
Change in Fasting Plasma Glucagon
Measured: Day 1 and Day 15
Change in plasma insulin, evaluated through area under the plasma insulin concentration-time curve (AUC0-3 hours) during the OGTT
Measured: Day -2 and Day 14
Change in plasma insulin maximal concentration (Cmax) level during the OGTT
Measured: Day -2 and Day 14
Change in plasma insulin concentration at 2 hours time point plasma level during the OGTT
Measured: Day -2 and Day 14
Change in HbA1c value after 14 days of CPL207280 treatment
Measured: Day -14 and Day 15
Absolute change in homeostasis model assessment of ß-cell function (HOMA-ß)
Measured: Day -2 and Day 14
Number of Participants who experienced at least once Adverse Event related to the study product
Measured: Up to 28 days
Number of Participants who experienced at least once Hypoglycaemia episode
Measured: Up to 15 days
Number of Participants who discontinued study due to an Adverse Event related to the IMP
Measured: Up to 15 days
Number of Participants with abnormal laboratory values
Measured: Up to 15 days
Number of Participants with abnormal ECG values
Measured: Up to 15 days
Change from pre dose value to mean of post dose values of Total Bile Acids on Day 1 and 14
Measured: Pre dose Day 1, Day 14, post dose Day 1, Day 14
CPL207280 maximum observed concentration (Cmax)
Measured: Day 1, Day 8, Day 14
CPL207280 time corresponding to occurence of Cmax (tmax)
Measured: Day 1,Day 8, Day 14
CPL207280 AUC from time zero to infinity (AUC 0-inf)
Measured: Day 1, Day 8, Day 14
CPL207280 apparent terminal elimination half-life (t1/2)
Measured: Day 1, Day 8, Day 14
CPL207280 apparent clearance (CL/F)
Measured: Day 1, Day 8, Day 14
CPL207280 apparent volume of distribution during terminal phase (Vz/F)
Measured: Day 1, Day 8, Day 14
CPL207280 concentration immediately prior to dosing (Ctrough)
Measured: Day 1, Day 8, Day 14,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start21 Jan 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo- controlled, parallel-group study to explore the efficacy, safety, tolerability and PK of 4 different doses of CPL207280 administered for 14 days orally.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celon Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
- Investigators
- Małgorzata Jonak, Principal investigator, BioResearch Group Sp. Z o.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248776
- Sponsor's protocol ID
- 02GPR2021
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety and Pharmacokinetics After 2-weeks Administration of CPL207280 (GPR40 Agonist) in Subjects With Type 2 Diabetes (T2D)
- ClinicalTrials.gov ID
- NCT05248776
- Acronym / sponsor ID
- 02GPR2021
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Celon Pharma SAIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 21 Feb 2022 (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.
The planned study is to evaluate the efficacy, safety and pharmacokinetic (PK) properties of CPL207280 after multiple (14 days) administration in patients with type 2 diabetes.
Detailed description
A double-blind, randomized, placebo-controlled, parallel-group study of 4 different doses of CPL207280 administered orally for 14 days. Approximately 80 participants will be randomized at a 1:1:1:1:1 ratio to 5 arms to receive Investigational Medicinal Product (IMP) or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Double-blind, randomized, placebo- controlled, parallel-group study to explore the efficacy, safety, tolerability and PK of 4 different doses of CPL207280 administered for 14 days orally.
| Arm | Type | Receives |
|---|---|---|
| CPL207280 60 mg | Experimental | Drug: CPL20728016 participants are to receive IMP at dose 60 mg.IMP will be administered for 14 days, every morning, after a minimum 8-hours overnight fast. Participants are to be randomized. |
| CPL207280 120 mg | Experimental | Drug: CPL20728016 participants are to receive IMP at dose 120 mg. IMP will be administered for 14 days, every morning, after a minimum 8-hours overnight fast. Participants are to be randomized. |
| CPL207280 240 mg | Experimental | Drug: CPL20728016 participants are to receive IMP at dose 240 mg. IMP will be administered for 14 days, every morning, after a minimum 8-hours overnight fast. Participants are to be randomized. |
| CPL207280 480 mg | Experimental | Drug: CPL20728016 participants are to receive IMP at dose 480 mg. IMP will be administered for 14 days, every morning, after a minimum 8-hours overnight fast. Participants are to be randomized |
| Placebo | Placebo comparator | Drug: Placebo16 participants are to receive masking placebo tablets once daily for 14 days, every morning, after a minimum 8-hours overnight fast. Participants are to be randomized |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participant with type 2 diabetes who are newly diagnosed (no longer than 3 years before the study) managed with diet and exercise alone, or who failed to achieve adequate glycemic control on a stable dose of metformin and willing to discontinue it at least 10 days prior to randomization and during the study.
- Participant has fasting plasma glucose level less than or equal 180 mg/dL.
- Participant has calculated homeostasis model assessment for insulin resistance (HOMA-IR) value less than or equal to 7.
- Participant has body-mass index (BMI): ≥ 18.50 kg/m² and ≤ 40.00 kg/m².
- Participant should have a HbA1c concentration greater than or equal to 6.0% and less than or equal to 8.0%.
Key exclusion criteria (17 listed)
- Participant has a c-peptide value less than 0.5 nmol/l.
- Participant has a history of abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy), thoracic, or non-peripheral vascular surgery within 6 months prior to the study.
- Participant has a history of cardiac arrhythmia, systolic dysfunction, congestive heart failure, angina, myocardial ischemia or infarction, or stroke within 1 year prior to the study, or the presence of an abnormal ECG that, in the investigator's opinion, is clinically significant.
- Participant has a history of drug abuse or a history of alcohol abuse within 2 years prior to the study.
- Participant has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. This criterion does not apply to basal cell or stage I squamous cell carcinoma of the skin.
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 |
|---|---|---|
| CPL207280IMP is a tablet with CPL207280 as an Active Pharmaceutical Ingredient (API). | Drug | CPL207280 120 mg, CPL207280 240 mg, CPL207280 480 mg, CPL207280 60 mg |
| PlaceboMatching placebo tablet. | Drug | Placebo |
Primary outcome
Efficacy in lowering plasma glucose during the Oral Glucose Tolerance Test (OGTT) after 2 weeks of CPL207280 treatment
Time frame: Day -2 and Day -14
Change in plasma glucose, evaluated through area under the plasma glucose concentration- time curve AUC (0-3 h) during the OGTT.
25 secondary outcomes
Change in plasma glucose maximal concentration (Cmax) level during the OGTT
Time frame: Day -2 and Day 14
Change in plasma glucose concentration level at 2 hours timepoint level during the OGTT
Time frame: Day -2 and Day -14
Change in Fasting Plasma Glucose (FPG)
Time frame: Day 1 and Day 15
Change in Fasting Plasma Insulin (FPI)
Time frame: Day 1 and Day 15
Change in Fasting Plasma Proinsulin
Time frame: Day 1 and Day 15
Change in Fasting Plasma c-peptide
Time frame: Day 1 and Day 15
Change in Fasting Plasma Glucagon
Time frame: Day 1 and Day 15
Change in plasma insulin, evaluated through area under the plasma insulin concentration-time curve (AUC0-3 hours) during the OGTT
Time frame: Day -2 and Day 14
Change in plasma insulin maximal concentration (Cmax) level during the OGTT
Time frame: Day -2 and Day 14
Change in plasma insulin concentration at 2 hours time point plasma level during the OGTT
Time frame: Day -2 and Day 14
Change in HbA1c value after 14 days of CPL207280 treatment
Time frame: Day -14 and Day 15
Absolute change in homeostasis model assessment of ß-cell function (HOMA-ß)
Time frame: Day -2 and Day 14
Number of Participants who experienced at least once Adverse Event related to the study product
Time frame: Up to 28 days
Number of Participants who experienced at least once Hypoglycaemia episode
Time frame: Up to 15 days
Number of Participants who discontinued study due to an Adverse Event related to the IMP
Time frame: Up to 15 days
Number of Participants with abnormal laboratory values
Time frame: Up to 15 days
Number of Participants with abnormal ECG values
Time frame: Up to 15 days
Change from pre dose value to mean of post dose values of Total Bile Acids on Day 1 and 14
Time frame: Pre dose Day 1, Day 14, post dose Day 1, Day 14
CPL207280 maximum observed concentration (Cmax)
Time frame: Day 1, Day 8, Day 14
CPL207280 time corresponding to occurence of Cmax (tmax)
Time frame: Day 1,Day 8, Day 14
CPL207280 AUC from time zero to infinity (AUC 0-inf)
Time frame: Day 1, Day 8, Day 14
CPL207280 apparent terminal elimination half-life (t1/2)
Time frame: Day 1, Day 8, Day 14
CPL207280 apparent clearance (CL/F)
Time frame: Day 1, Day 8, Day 14
CPL207280 apparent volume of distribution during terminal phase (Vz/F)
Time frame: Day 1, Day 8, Day 14
CPL207280 concentration immediately prior to dosing (Ctrough)
Time frame: Day 1, Day 8, Day 14,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- 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.
Małgorzata Jonak principal investigator
BioResearch Group Sp. Z o.o.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPL207280 in people with Type 2 Diabetes, run by Celon Pharma SA at 1 site in Poland.
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 14 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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 Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in lowering plasma glucose during the Oral Glucose Tolerance Test (OGTT) after 2 weeks of CPL207280 treatment (time frame: Day -2 and Day -14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.