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

NCT02111083 | Completed Phase 1 Results

• 2 other identifiers: 15418F3Z-EW-IOQM
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

• 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-∞)]

Secondary Outcomes (4)

• Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)

  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.

• Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)

  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.

Study Arms (2)

Insulin Lispro A

ACTIVE COMPARATOR

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 \[T\]).

Biological: Insulin Lispro

Insulin Lispro B

EXPERIMENTAL

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 \[R\]).

Biological: Insulin Lispro

Interventions

Insulin Lispro BIOLOGICAL

LY275585 administered SC.

Insulin Lispro A; Insulin Lispro B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 117597, Singapore

Location

MeSH Terms

Interventions

Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 21, 2015
• Results First Posted: May 21, 2015

Record last verified: 2015-05

Locations

SG (1)