A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants

Phase 1

Completed

Brief Summary: The study involves 4 injections of insulin lispro and its purpose is to:

* Determine if 2 formulations of insulin lispro are treated by the body in a similar way.

* Compare how the 2 formulations of insulin lispro affect blood sugar level.

* Determine the safety of each insulin lispro formulations and any side effects that might be associated with them when given to healthy participants. The study is expected to last up to approximately 9 weeks for each participant.

Recruitment & Eligibility

Inclusion Criteria

Are healthy males or females
Body mass index (BMI) between 18.5 and 29.9 kilogram per meter squared (kg/m^2)
Are nonsmokers
Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.

Exclusion Criteria

History of first-degree relatives known to have diabetes mellitus
Evidence of significant active neuropsychiatric disease
Evidence of an acute infection with fever or infectious disease
Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
Have used systemic glucocorticoids within 3 months prior to entry into the study.
Have donated blood of 1 unit or more within the last 3 months prior to study entry
Excessive alcohol intake
Have a fasting venous blood glucose (fasting blood glucose [FBG], plasma) >6 millimoles per liter (mmol/L) at screening
Have positive hepatitis B surface antigen.

Arm && Interventions

Group	Intervention	Description
Insulin Lispro A	Insulin Lispro	Insulin Lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200)administered subcutaneously (SC) once in two of four study periods.(Two doses of test \[T\]).
Insulin Lispro B	Insulin Lispro	Insulin Lispro B 20 units (U) of strength 100 U/mL (U-100) administered SC once in two of four study periods.(Two doses of reference \[R\]).

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)	Day 1, predose through 8 hours post dose in each period
Pharmacokinetic Parameter: Area Under the Curve(AUC)	Zero to infinity [AUC(0-∞)]
Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)	Day 1, predose through 8 hours post dose in each period.

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)	Day 1, predose through 8 hours post dose in each period.
Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)	Day1, predose through 8 hours post dose in each period.	The total amount of glucose infused during the euglycemic clamp procedure.
Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)	Day 1, predose through 8 hours post dose in each period.	The maximum observed glucose infusion rate during the euglycemic clamp procedure.
Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)	Day 1, predose through 8 hours post dose in each period.

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇸🇬
Singapore, Singapore

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial