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OpenTrials
Completed

NCT Number: NCT02955953

A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2963016

Drug

Administered SC

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2016
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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