PK of Insulin
Conditions
Interventions
Insulin aspart (Fiasp), intravaginal administration using the MedRing.
Insulin aspart (Fiasp), subcutaneous administration by s.c. injection
Sponsors
LiGalli BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Eligible subjects must meet all the following inclusion criteria at screening: 1. Willing to give written informed consent and willing and able to comply with the study protocol. 2. Female subjects with diabetes mellitus type 1 of childbearing potential (women of childbearing potential, WOCBP) aged between 18 and 45 years (inclusive). 3. Subject is on insulin therapy under multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII). 4. Subject is on continuous glucose monitoring (CGM) with a CGM device or a flash monitoring device (e.g. Abbott Freestyle Libre) more than 24 hours in situ. 5. Subject is in good general health (apart from T1DM), according to the investigator*s judgement based on vital signs, medical history, physical examination, and laboratory tests performed. 6. Body mass index between 18-32 kg*m2 (inclusive) and with a minimum body weight of 50 kg at screening. 7. Ability to communicate well with the investigator in the Dutch language and willing to comply with the study restrictions. 8. Using contraceptives of second generation containing ethinylestradiol and progesterone derivate. This includes a hormone-containing IUD (e.g. Mirena), second generation oral contraceptive pill, hormonal contraception using parenteral medroxyprogesteron or subcutaneous etonogestrel.
Exclusion criteria
Exclusion criteria: Eligible subjects must meet none of the following exclusion criteria at screening: 1. (A history of) any clinically significant medical condition or abnormality, as judged by the investigator, in physical examination, laboratory test results (including chemistry panel with hepatic and renal panels, complete blood count, and urine dipstick) or electrocardiography (ECG) at screening. In the case of uncertain or questionable results, tests performed during screening may be repeated to confirm eligibility or judged by the investigator to be clinically irrelevant for healthy subjects. 2. Patients on (hybrid) closed loop systems, i.e. Medtronic 670G/780 pump. 3. Patients with unstable glucose regulation in opinion of the investigators, for example frequent hypo- or hyperglycemia or with hypoglycemia unawareness. 4. Being a virgin. 5. History of sexual abuse/violence. 6. First day of last withdrawal bleeding 3 months prior to screening. 14. High risk for sexual transmitted diseases (STD): a. 3 or more different sexual contacts in last 6 months, and/or b. is a sex worker or visits them and/or c. has a partner with an STD risk as described (a. and/or b.), and/or d. partner is a male who has sex with male. 15. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against insulin aspart (Fiasp), or multiple drug allergies (non-active hay fever is acceptable). 16. Participation in any marketed or investigational drug or device study within 3 months or 5 half-lives (whichever is longer) prior to first dosing. 17. Use of prescription medication or any other substance that in the opinion of the investigators may influence the outcome of the study (e.g. systemic steroids) within 21 days prior to study drug administrations, or less than five half-lives (whichever is longer, and during the course of the study). Exceptions are the incidental use of OTC medications paracetamol (up to 4 g/day) and ibuprofen (up to 1 g/day) which are allowed within two days of clinical assessments. 18. Use of alcohol during the 24 hours prior to screening and/or an unwillingness to abstain from alcohol consumption during the stay at the clinical unit, and for at least 24 hours prior to each study visit. 19. Positive urine drug screen or alcohol test at screening and/or at study days. 20. Loss or donation of blood over 500 mL within four months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters by non-compartmental analysis the plasma concentration-time data: * AUCinf, AUClast, Cmax, tmax, t1/2, tlag, CL/F, Vz/F * Dose-normalized PK parameters: AUCinf, AUClast, Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| * Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit * Hypo- or hyperglycaemic events by continuous blood glucose monitoring. * Concomitant medication throughout the study at every study visit * Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule * Physical examination including in speculum examination per assessment schedule | — |
Countries
Netherlands
Outcome results
None listed