A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02955953

Enrollment

127

Registered

2016-11-04

Start date

2016-11-14

Completion date

2017-01-04

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGLY2963016

Administered SC

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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
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

Measure	Time frame
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
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026