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

NCT ID: NCT02111083

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-08-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Insulin Lispro A

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 \[T\]).

Group Type: ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type: BIOLOGICAL

LY275585 administered SC.

Insulin Lispro B

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 \[R\]).

Group Type: EXPERIMENTAL

Insulin Lispro

Intervention Type: BIOLOGICAL

LY275585 administered SC.

Interventions

Insulin Lispro

LY275585 administered SC.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

Singapore

Other Identifiers

F3Z-EW-IOQM

Identifier Type: OTHER

Identifier Source: secondary_id

15418

Identifier Type: -

Identifier Source: org_study_id