NCT02111083CompletedPhase 1
Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Pharmacokinetic Parameter: Area Under the Curve(AUC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Pharmacokinetic Parameter: Area Under the Curve(AUC)
Time Frame: Zero to infinity [AUC(0-∞)]
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)
Time Frame: Day 1, predose through 8 hours post dose in each period
Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)
Time Frame: Day 1, predose through 8 hours post dose in each period.
Secondary Outcomes
- Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)(Day1, predose through 8 hours post dose in each period.)
- Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)(Day 1, predose through 8 hours post dose in each period.)
- Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)(Day 1, predose through 8 hours post dose in each period.)
- Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)(Day 1, predose through 8 hours post dose in each period.)
Investigators
Study Sites (2)
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