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Efficacy, Safety and Pharmacokinetics Study of CPL207280 After 2-weeks Administration in Subjects With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
CPL207280
Placebo
Sponsored by
Celon Pharma SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • BioResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

CPL207280 60 mg

CPL207280 120 mg

CPL207280 240 mg

CPL207280 480 mg

Placebo

Arm Description

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.

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.

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in plasma glucose maximal concentration (Cmax) level during the OGTT
Change in plasma glucose concentration level at 2 hours timepoint level during the OGTT
Change in Fasting Plasma Glucose (FPG)
Change in Fasting Plasma Insulin (FPI)
Change in Fasting Plasma Proinsulin
Change in Fasting Plasma c-peptide
Change in Fasting Plasma Glucagon
Change in plasma insulin, evaluated through area under the plasma insulin concentration-time curve (AUC0-3 hours) during the OGTT
Change in plasma insulin maximal concentration (Cmax) level during the OGTT
Change in plasma insulin concentration at 2 hours time point plasma level during the OGTT
Change in HbA1c value after 14 days of CPL207280 treatment
Absolute change in homeostasis model assessment of ß-cell function (HOMA-ß)
Number of Participants who experienced at least once Adverse Event related to the study product
Number of Participants who experienced at least once Hypoglycaemia episode
Number of Participants who discontinued study due to an Adverse Event related to the IMP
Number of Participants with abnormal laboratory values
Number of Participants with abnormal ECG values
Change from pre dose value to mean of post dose values of Total Bile Acids on Day 1 and 14
CPL207280 maximum observed concentration (Cmax)
CPL207280 time corresponding to occurence of Cmax (tmax)
CPL207280 AUC from time zero to infinity (AUC 0-inf)
CPL207280 apparent terminal elimination half-life (t1/2)
CPL207280 apparent clearance (CL/F)
CPL207280 apparent volume of distribution during terminal phase (Vz/F)
CPL207280 concentration immediately prior to dosing (Ctrough)

Full Information

First Posted
February 4, 2022
Last Updated
February 7, 2023
Sponsor
Celon Pharma SA
Collaborators
National Center for Research and Development, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT05248776
Brief Title
Efficacy, Safety and Pharmacokinetics Study of CPL207280 After 2-weeks Administration in Subjects With Type 2 Diabetes
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celon Pharma SA
Collaborators
National Center for Research and Development, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Double- Blind. The identity of IMP and placebo will not be known to investigators, research staff and participants.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPL207280 60 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
CPL207280 120 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
CPL207280 240 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
CPL207280 480 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CPL207280
Intervention Description
IMP is a tablet with CPL207280 as an Active Pharmaceutical Ingredient (API).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet.
Primary Outcome Measure Information:
Title
Efficacy in lowering plasma glucose during the Oral Glucose Tolerance Test (OGTT) after 2 weeks of CPL207280 treatment
Description
Change in plasma glucose, evaluated through area under the plasma glucose concentration- time curve AUC (0-3 h) during the OGTT.
Time Frame
Day -2 and Day -14
Secondary Outcome Measure Information:
Title
Change in plasma glucose maximal concentration (Cmax) level during the OGTT
Time Frame
Day -2 and Day 14
Title
Change in plasma glucose concentration level at 2 hours timepoint level during the OGTT
Time Frame
Day -2 and Day -14
Title
Change in Fasting Plasma Glucose (FPG)
Time Frame
Day 1 and Day 15
Title
Change in Fasting Plasma Insulin (FPI)
Time Frame
Day 1 and Day 15
Title
Change in Fasting Plasma Proinsulin
Time Frame
Day 1 and Day 15
Title
Change in Fasting Plasma c-peptide
Time Frame
Day 1 and Day 15
Title
Change in Fasting Plasma Glucagon
Time Frame
Day 1 and Day 15
Title
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
Title
Change in plasma insulin maximal concentration (Cmax) level during the OGTT
Time Frame
Day -2 and Day 14
Title
Change in plasma insulin concentration at 2 hours time point plasma level during the OGTT
Time Frame
Day -2 and Day 14
Title
Change in HbA1c value after 14 days of CPL207280 treatment
Time Frame
Day -14 and Day 15
Title
Absolute change in homeostasis model assessment of ß-cell function (HOMA-ß)
Time Frame
Day -2 and Day 14
Title
Number of Participants who experienced at least once Adverse Event related to the study product
Time Frame
Up to 28 days
Title
Number of Participants who experienced at least once Hypoglycaemia episode
Time Frame
Up to 15 days
Title
Number of Participants who discontinued study due to an Adverse Event related to the IMP
Time Frame
Up to 15 days
Title
Number of Participants with abnormal laboratory values
Time Frame
Up to 15 days
Title
Number of Participants with abnormal ECG values
Time Frame
Up to 15 days
Title
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
Title
CPL207280 maximum observed concentration (Cmax)
Time Frame
Day 1, Day 8, Day 14
Title
CPL207280 time corresponding to occurence of Cmax (tmax)
Time Frame
Day 1,Day 8, Day 14
Title
CPL207280 AUC from time zero to infinity (AUC 0-inf)
Time Frame
Day 1, Day 8, Day 14
Title
CPL207280 apparent terminal elimination half-life (t1/2)
Time Frame
Day 1, Day 8, Day 14
Title
CPL207280 apparent clearance (CL/F)
Time Frame
Day 1, Day 8, Day 14
Title
CPL207280 apparent volume of distribution during terminal phase (Vz/F)
Time Frame
Day 1, Day 8, Day 14
Title
CPL207280 concentration immediately prior to dosing (Ctrough)
Time Frame
Day 1, Day 8, Day 14,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Małgorzata Jonak
Organizational Affiliation
BioResearch Group Sp. Z o.o.
Official's Role
Principal Investigator
Facility Information:
Facility Name
BioResearch
City
Kajetany
State/Province
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna z Jarus-Dziedzic, MD, PhD
Phone
+48 22 112195152
Email
rekrutacja@bioresearch.pl
First Name & Middle Initial & Last Name & Degree
Małgorzata Jonak, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy, Safety and Pharmacokinetics Study of CPL207280 After 2-weeks Administration in Subjects With Type 2 Diabetes

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