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Clinical Trial Details

Trial ID: L2003
Source ID: NCT05248776
Associated Drug: Cpl207280
Title: Efficacy, Safety and Pharmacokinetics Study of CPL207280 After 2-weeks Administration in Subjects With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: CPL207280|DRUG: Placebo
Outcome Measures: Primary: 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: 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|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,
Sponsor/Collaborators: Sponsor: Celon Pharma SA | Collaborators: National Center for Research and Development, Poland
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 80
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-01-21
Completion Date: 2023-06-30
Results First Posted:
Last Update Posted: 2023-02-08
Locations: BioResearch, Kajetany, Nadarzyn, 05-830, Poland
URL: https://clinicaltrials.gov/show/NCT05248776