A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

Healthy Clinical Trial

Official title:

Bioequivalence Study Comparing the Pharmacokinetics and Glucodynamics of LY2963016 U-200 Formulation With LY2963016 U-100 Formulation in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955953
• Other study ID #: 16249
• Secondary ID: I4L-MC-ABEV
• Status: Completed
• Phase: Phase 1
• First received: November 3, 2016
• Last updated: March 20, 2017
• Start date: November 14, 2016
• Est. completion date: January 4, 2017

Study information

• Verified date: March 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will aim to evaluate the following:

• Whether there are any differences in the way the body handles LY2963016 U-200 and LY2963016 U-100.

• How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.

• How LY2963016 U-200 affects the level of blood sugar in the body compared with LY2963016 U-100.

The study will last up to 17 weeks for each participant, including initial screening and follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 4, 2017
• Est. primary completion date: January 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have a body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m²)

• Have a fasting plasma glucose less than (<) 6.0 millimoles per liter (mmol/L) (108 milligram per deciliter [mg/dL])

• Have venous access sufficient to allow for blood sampling and clamp procedures per protocol

Exclusion Criteria:

• Have known allergies to the study drug, or any components of the formulation

• Have donated or had a blood loss of 450 milliliter (mL) within 3 months prior to study enrollment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY2963016
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, 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	Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation		One hour before dosing up to 48 hours following administration of study drug
Primary	Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation		One hour before dosing up to 48 hours following administration of study drug
Secondary	Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of LY2963016 U-200 and LY2963016 U-100		One hour before dosing up to about 30 hours post clamp procedure
Secondary	Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of LY2963016 U-200 and LY2963016 U-100		One hour before dosing up to about 30 hours post clamp procedure