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

NCT05248776 | Unknown Phase 2

• 1 other identifier: 02GPR2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  Day -2 and Day -14

Secondary Outcomes (25)

• Change in plasma glucose maximal concentration (Cmax) level during the OGTT

  Day -2 and Day 14

• Change in plasma glucose concentration level at 2 hours timepoint level during the OGTT

  Day -2 and Day -14

• Change in Fasting Plasma Glucose (FPG)

  Day 1 and Day 15

• Change in Fasting Plasma Insulin (FPI)

  Day 1 and Day 15

• Change in Fasting Plasma Proinsulin

  Day 1 and Day 15

Study Arms (5)

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.

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.

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.

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

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

Drug: Placebo

Interventions

CPL207280 DRUG

IMP is a tablet with CPL207280 as an Active Pharmaceutical Ingredient (API).

CPL207280 120 mg; CPL207280 240 mg; CPL207280 480 mg; CPL207280 60 mg

Placebo DRUG

Matching placebo tablet.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celon Pharma SA: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (1)

BioResearch

Kajetany, Nadarzyn, 05-830, Poland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

CPL207280

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Małgorzata Jonak

  BioResearch Group Sp. Z o.o.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double- Blind. The identity of IMP and placebo will not be known to investigators, research staff and participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 21, 2022
• Study Start: January 21, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)