A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

March 20, 2017 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY2963016 U-200 Formulation (Test)
LY2963016 test formulation administered as a subcutaneous (SC) injection in one of two or two of four study periods.
Drug: LY2963016
Administered SC
Experimental: LY2963016 U-100 Formulation (Reference)
LY2963016 reference formulation administered as a SC injection in one of two or two of four study periods.
Drug: LY2963016
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation
Time Frame: One hour before dosing up to 48 hours following administration of study drug
One hour before dosing up to 48 hours following administration of study drug
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation
Time Frame: One hour before dosing up to 48 hours following administration of study drug
One hour before dosing up to 48 hours following administration of study drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of LY2963016 U-200 and LY2963016 U-100
Time Frame: One hour before dosing up to about 30 hours post clamp procedure
One hour before dosing up to about 30 hours post clamp procedure
Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of LY2963016 U-200 and LY2963016 U-100
Time Frame: One hour before dosing up to about 30 hours post clamp procedure
One hour before dosing up to about 30 hours post clamp procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2016

Primary Completion (Actual)

January 4, 2017

Study Completion (Actual)

January 4, 2017

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 16249
  • I4L-MC-ABEV (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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