NCT03421379 SoA

	Screening	Period 1						Washout	Period 2		Period 1			Follow-up Epoch
	Screening	Period 1, Day -1	Period 1, Day 1	Period 1, Day 1	Period 1, Day 1	Period 1, Day 1	Period 1, Day 1	Wash Out	Period 2, Day -1	Period 2, Day 1	Period 1, Day 1	Period 1, Day 1	Period 1, Day 1	Follow-up	Follow-up

	0..26 Days							0.. 11 Days						2..2 Days
Informed Consent	X
Randomization			X
Admission to CRU		X							X
Discharge from CRU							X						X
Medical History	X
Collect Pre-existing Conditions and Adverse Events	X	X		X				X	X					X
Physical Exam	X													X
Height and Weight	X													X
Hypoglycemic Events						X						X
Collect Concomitant Medications	X	X		X				X	X	X				X
Insulin infusion to Induce Hypoglycemia					X						X
PG Monitoring					X						X
Study Treatment Administration						X						X
Vital Signs (Supine Blood Pressure, Pulse Rate, and Body Temperature)	X													X
Single 12-lead ECG (Local)	X													X
Triplicate 12-lead ECG (Central)
Clinical Serology Tests	X
Clinical Lab Tests	X													X
HbA1c	X			X
Pregnancy Test (Female patients of childbearing potential only)	X	X							X					X
FSH (Female patients only)	X
Ethanol testing	X
Urine Drug Screen	X
PK (Glucagon)														X	X
Plasma Glucose for PD
Genetic Sample (stored)		X
Anti-glucagon Antibodies				X										X	X
Clarke Hypoglycemia Awareness Survey		X							X
Nasal and Non-nasal Score Quaestionnaire
Edinburgh Hypoglycemia Scale: Experimental Hypoglycemia
Weight
Injection-Site Assessment
Nasal Inspection
Meal