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| Name | Class |
|---|---|
| National Center for Research and Development, Poland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPL207280 | Drug | IMP is a tablet with CPL207280 as an Active Pharmaceutical Ingredient (API). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Małgorzata Jonak | BioResearch Group Sp. Z o.o. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioResearch | Recruiting | Kajetany | Nadarzyn | 05-830 | Poland |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000721547 | CPL207280 |
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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.
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Double- Blind. The identity of IMP and placebo will not be known to investigators, research staff and participants.
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| Placebo | Drug | Matching placebo tablet. |
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| 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 |
| Change in Fasting Plasma c-peptide | Day 1 and Day 15 |
| Change in Fasting Plasma Glucagon | 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 | Day -2 and Day 14 |
| Change in plasma insulin maximal concentration (Cmax) level during the OGTT | Day -2 and Day 14 |
| Change in plasma insulin concentration at 2 hours time point plasma level during the OGTT | Day -2 and Day 14 |
| Change in HbA1c value after 14 days of CPL207280 treatment | Day -14 and Day 15 |
| Absolute change in homeostasis model assessment of ß-cell function (HOMA-ß) | Day -2 and Day 14 |
| Number of Participants who experienced at least once Adverse Event related to the study product | Up to 28 days |
| Number of Participants who experienced at least once Hypoglycaemia episode | Up to 15 days |
| Number of Participants who discontinued study due to an Adverse Event related to the IMP | Up to 15 days |
| Number of Participants with abnormal laboratory values | Up to 15 days |
| Number of Participants with abnormal ECG values | Up to 15 days |
| Change from pre dose value to mean of post dose values of Total Bile Acids on Day 1 and 14 | Pre dose Day 1, Day 14, post dose Day 1, Day 14 |
| CPL207280 maximum observed concentration (Cmax) | Day 1, Day 8, Day 14 |
| CPL207280 time corresponding to occurence of Cmax (tmax) | Day 1,Day 8, Day 14 |
| CPL207280 AUC from time zero to infinity (AUC 0-inf) | Day 1, Day 8, Day 14 |
| CPL207280 apparent terminal elimination half-life (t1/2) | Day 1, Day 8, Day 14 |
| CPL207280 apparent clearance (CL/F) | Day 1, Day 8, Day 14 |
| CPL207280 apparent volume of distribution during terminal phase (Vz/F) | Day 1, Day 8, Day 14 |
| CPL207280 concentration immediately prior to dosing (Ctrough) | Day 1, Day 8, Day 14, |
| D004700 | Endocrine System Diseases |