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| Name | Class |
|---|---|
| Profil Institut für Stoffwechselforschung GmbH | INDUSTRY |
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The purpose with the study is to assess pharmacokinetics of NEX-22A in patients with type 2 diabetes.
The trial is a single-centre, open-label, single ascending dose study. After being informed about the study and potential risks, all patients given written informed consent will undergo a screening to determine eligibility for study entry. Each subject will be enrolled in one of the three sequential cohorts, comprising one single dose of NEX-22A liraglutide injection. Each cohort will have a sentinel participant. NEX-22A will be administered in sequential cohorts. Before initiating a new dose cohort, safety, tolerability and PK data for all treated subjects must have been reviewed by the dose escalation committee. Blood samples for PK analysis will be withdrawn at specified timepoints over a period of 36 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of NEX-22-01 | Experimental | The trial is single ascending dose study where the dose is escalated depending on previous cohorts PK data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEX-22A, a prolonged release formulation of liraglutide | Drug | NEX-22A, a prolonged release formulation of liraglutide |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes | Blood samples will be collected in order to calculate a PK profile. Maximum observed plasma concentration (Cmax) | From administration of study drug until 36 days |
| To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes | Blood samples will be collected in order to calculate a PK profile. Time of occurrence of Cmax (Tmax) | From administration of study drug until 36 days |
| To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes | Blood samples will be collected in order to calculate a PK profile. occurrence of Area under the plasma concentration vs. time curve (AUC) from time 0 to 8 hours (AUC0-8h) | From administration of study drug until 36 days |
| To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes | Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 12 hours (AUC0-12h) | From administration of study drug until 36 days |
| To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes | Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 24 hours (AUC0-24h) | From administration of study drug until 36 days |
| To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-related adverse events a assessed by frequency | Number of events.Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with treatment-related adverse events a assessed by seriouness |
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Inclusion Criteria:
Exclusion Criteria:
Explanatory note on Exclusion Criterion 25: Exceptions are stable doses of metformin, SGLT2-blockers, low dose aspirin, antihypertensives, statins, thyroid hormones or occasional use of paracetamol or ibuprofen, and ,if female, with the exception of menopausal hormone replacement therapy.
Explanatory note on Exclusion Criterion 29: A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile due to hysterectomy, or bilateral salpingectomy, or bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
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| Name | Affiliation | Role |
|---|---|---|
| Grit Andersen, MD | Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil | Neuss | 41460 | Germany |
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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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Single ascending dose study including 3 cohorts (3 patients/cohort). The subjects will be enrolled in the respective cohorts, starting with cohort 1. NEX-22A will be administered in a sentinel fashion within the cohorts. A single participant will be dosed first in every cohort. If there are no safety concerns as judged by the investigator, the remaining subjects will be dosed at least 10 days after the sentinel.
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Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 72 hours (AUC0-72h) |
| From administration of study drug until 36 days |
| To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes | Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 7 days (AUC0-7days) | From administration of study drug until 36 days |
| To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes | Blood samples will be collected in order to calculate a PK profile. AUC from 0 to time of last measurable plasma concentration (AUClast) | From administration of study drug until 36 days |
| To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes | Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to infinity (AUCinf) | From administration of study drug until 36 days |
| To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes | Blood samples will be collected in order to calculate a PK profile. Terminal elimination half-life (T1/2) | From administration of study drug until 36 days |
Seriousness of adverse events. Descriptive individual data. |
| From administration of study drug until 36 days |
| Number of subjects with treatment-related adverse events a assessed by intensity | Intensity of adverse events. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with treatment-related adverse events a assessed by relationship to study treatment | Relationship to study treatment. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the systolic blood pressure at 36 days | Measured in mmHg after 10 minutes supine rest. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in in the diastolic blood pressure at 36 days | Measured in mmHg after 10 minutes supine rest. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the ECG parameter PQ/PR at 36 days | Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the ECG parameter QRS at 36 days | Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the ECG parameter QT at 36 days | Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the ECG parameter QTcB at 36 days | Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the ECG parameter heart rate at 36 days | Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the haematology blood parameters measurements at 36 days | Blood samples for the analysis of haematology parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the clinical chemistry blood laboratory measurements at 36 days | Blood samples for the analysis of clinical chemistry parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the coagulation blood laboratory measurements at 36 days | Blood samples for the analysis of coagulation parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in plasma glucose measurement at 36 days | Blood samples for the analysis of plasma glucos will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the head at 36 days | Physical examination including assessment of the head. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the eyes at 36 days | Physical examination including assessment of the eyes. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the ears at 36 days | Physical examination including assessment of the ears. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the nose at 36 days | Physical examination including assessment of the nose. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the throat at 36 days | Physical examination including assessment of the throat. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the skin and mucosae at 36 days | Physical examination including assessment of the skin and mucosae. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the tyroid at 36 days | Physical examination including assessment of the tyroid. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the neurological status at 36 days | Physical examination including assessment of the neurological status. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the lungs at 36 days | Physical examination including assessment of the lungs. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the cardiovascular system at 36 days | Physical examination including assessment of the cardiovascular system including inspection, palpation, and auscultation.Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the gastrointestinal system incl mouth at 36 days | Physical examination including palpation of the gastrointestinal system incl mouth check. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the physical examination of the lymfh nodes incl mouth at 36 days | Physical examination including palpation of the lymfh nodes. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in the musculoskeletal system at 36 days. | Physical examination of the musculoskeletal system. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by visual inspection. | Visual inspection. Descriptive individual data. | From administration of study drug until 36 days |
| Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by photography. | Photography of injection site Descriptive individual data. | From administration of study drug until 36 days |
| D004700 | Endocrine System Diseases |