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

Healthy Volunteers Clinical Trial

Official title:

Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111083
• Other study ID #: 15418
• Secondary ID: F3Z-EW-IOQM
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2014
• Last updated: May 4, 2015
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• Insulin Lispro
LY275585 administered SC.

Locations

Country	Name	City	State
Singapore	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)		Day 1, predose through 8 hours post dose in each period	No
Primary	Pharmacokinetic Parameter: Area Under the Curve(AUC)		Zero to infinity [AUC(0-8)]	No
Secondary	Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)		Day 1, predose through 8 hours post dose in each period.	No
Secondary	Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)	The total amount of glucose infused during the euglycemic clamp procedure.	Day1, predose through 8 hours post dose in each period.	No
Secondary	Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)	The maximum observed glucose infusion rate during the euglycemic clamp procedure.	Day 1, predose through 8 hours post dose in each period.	No
Secondary	Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)		Day 1, predose through 8 hours post dose in each period.	No