A single-center pilot study to establish a novel hypoglycemic clamp procedure to assess the time to spontaneous recovery from hypoglycemia in people with and without diabetes

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• Exclusion Criteria for Participants with Diabetes - Medical Conditions: 1. Have type 1 diabetes mellitus. 2. Have known allergies to insulin aspart. 3. Have had an episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. 4. Do not have enough ability to communicate an understanding of hypoglycemic symptoms and the appropriate treatment of hypoglycemia in the opinion of the Investigator. 5. Have had an episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization within the 6 months prior to screening (Visit 1). 6. Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator. 7. Have impaired renal estimated glomerular filtration rate <60 mL/min/1.73 m2 calculated by Chronic Kidney Disease-Epidemiology. 8. Show evidence of possible chronic or active hepatitis B, including hepatitis B core antibody and/or hepatitis B surface antigen positivity. 9. Have a positive HCV antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV RNA test is negative. 10. Have evidence of HIV infection and/or positive HIV antibodies. 11. Have a history of • acute myocardial infarction, • peripheral artery disease, • ischemic heart disease, • congestive heart failure, New York Heart Association class III or IV, • cerebrovascular accident (stroke [including transient ischemic attack]), • coronary artery revascularization, • hospitalization for unstable angina, and/or • hospitalization due to congestive heart failure. 12. Have a history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome). 13. Have a 12-lead ECG abnormality at screening that, in the opinion of the Investigator, increases the risks associated with participating in the study or may confound ECG data analysis. 14. Have the following sustained measurements at screening for at least 3 months: systolic blood pressure of greater than 160 mm Hg, diastolic blood pressure of greater than 100 mm Hg, or sitting pulse rate of less than 50 bpm or greater than 100 bpm. This exclusion criterion also pertains to participants being on antihypertensives. 15. Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for <5 years prior to screening (Visit 1). Exceptions: • Basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; • Cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline; or • In situ prostate cancer. 16. Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointenstinal, endocrine, hematological, neurological, or mental health disorders constituting a risk when undergoing hypoglycemic clamp; or of interfering with the interpretation of data, as judged by the Investigator. 17. Have had a blood donation of 500 mL or more in the last 3 months or any blood donation within the last month prior to screening (Visit 1). 18. Have a history of significant atopy (severe or multiple allergic manifestations), or anaphylactic reaction.
• Exclusion Criteria for Participants with Diabetes - Prior or Concomitant Therapy: 19. Have taken any glucose-lowering medications other than metformin, DPP-IV inhibitors, sulfonylureas, glinides, or SGLT2 inhibitors or GLP-1 receptor agonists any time within the 3 months prior to screening. • Short term use of insulin (<14 days) for treatment of acute conditions is allowed in the 3-month period prior to screening. 20. Treated with any medication known to interfere with glucose metabolism, i.e. non-selective beta-blockers, systemic glucocorticoid therapy (excluding topical, intraarticular or inhaled preparations not reaching circulation), monoamine oxidase (MAO) inhibitors within 30 days or 5 half-lifes (whichever is longer) before screening. Stable therapy with hormonal contraceptives (2 months) is allowed.
• Exclusion Criteria for Participants with Diabetes - Substance Abuse: 21. Having a history of alcohol abuse within 1 year prior to screening, or positive alcohol breath test at screening. 22. Smoke more than 10 cigarettes, or cigarette equivalent (as determined by Investigator), per day or are unable to abide by the study site’s tobacco and nicotine containing product restrictions. 23. History of drug abuse or positive result on urine drug test for drugs of abuse at screening. Have evidence of current or history of any substance use disorder(s) of any severity as defined by the DSM-V in the opinion of the Investigator, excepting disorders of nicotine or caffeine use. 24. Are unwilling to comply with the lifestyle and dietary restrictions required for this study.
• Exclusion Criteria for Participants with Diabetes - Others: 25. Women who are lactating, pregnant or intend to become pregnant or to breastfeed during the study. 26. Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. 27. Are study site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
• Exclusion Criteria for Participants without Diabetes - Medical Conditions: 1. Have impaired renal estimated glomerular filtration rate <60 mL/min/1.73 m2 calculated by Chronic Kidney Disease-Epidemiology. 2. Show evidence of possible chronic or active hepatitis B, including hepatitis B core antibody and/or hepatitis B surface antigen positivity. 3. Have a positive HCV antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV RNA test is negative. 4. Have evidence of HIV infection and/or positive HIV antibodies. 5. Have a history of • acute myocardial infarction, • peripheral artery disease, • ischemic heart disease, • congestive heart failure, New York Heart Association class III or IV, • cerebrovascular accident (stroke [including transient ischemic attack]), • coronary artery revascularization, • hospitalization for unstable angina, and/or • hospitalization due to congestive heart failure. 6. Have a history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome). 7. Have a 12-lead ECG abnormality at screening that, in the opinion of the Investigator, increases the risks associated with participating in the study or may confound ECG data analysis. 8. Supine blood pressure at screening outside the range of 90 – 140 mmHg for systolic or 50 – 90 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the participant can be included in the study). 9. Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for <5 years prior to screening (Visit 1). Exceptions: • Basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; • Cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline; or • In situ prostate cancer. 10. Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointenstinal, endocrine, hematological, neurological, or mental health disorders constituting a risk when undergoing hypoglycemic clamp; or of interfering with the interpretation of data, as judged by the Investigator. 11. Have had a blood donation of 500 mL or more in the last 3 months or any blood donation within the last month prior to screening (Visit 1). 12. Have a history of significant atopy (severe or multiple allergic manifestations), or anaphylactic reaction.
• Exclusion Criteria for Participants without Diabetes - Prior or Concomitant Therapy: 13. Treated with any medication known to interfere with glucose metabolism, i.e. non-selective beta-blockers, systemic glucocorticoid therapy (excluding topical, intraarticular or inhaled preparations not reaching circulation), monoamine oxidase (MAO) inhibitors within 30 days or 5 half-lifes (whichever is longer) before screening. Stable therapy with hormonal contraceptives (2 months) is allowed.