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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT02111083

15418

F3Z-EW-IOQM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Insulin Lispro A

Active Comparator group

Description:

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 \[T\]).

Treatment:

Biological: Insulin Lispro

Insulin Lispro B

Experimental group

Description:

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 \[R\]).

Treatment:

Biological: Insulin Lispro