Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 72 hours (AUC0-72h) |
From administration of study drug until 36 days |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Secondary |
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 |
|
| Secondary |
Number of subjects with treatment-related adverse events a assessed by seriouness |
Seriousness of adverse events. Descriptive individual data. |
From administration of study drug until 36 days |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
