A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY2963016

• Registration Number: NCT02955953
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-04
• Study Start: 2016-11-14
• Primary Completion: 2017-01-04
• Study Completion: 2017-01-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY2963016 U-100 Formulation (Reference)	LY2963016	LY2963016 reference formulation administered as a SC injection in one of two or two of four study periods.
LY2963016 U-200 Formulation (Test)	LY2963016	LY2963016 test formulation administered as a subcutaneous (SC) injection in one of two or two of four study periods.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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, Singapore