A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY2963016

Study type: Interventional

Funder types: Industry

Identifiers

NCT02955953

16249

I4L-MC-ABEV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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127 participants in 2 patient groups

LY2963016 U-200 Formulation (Test)

Experimental group

Description:

LY2963016 test formulation administered as a subcutaneous (SC) injection in one of two or two of four study periods.

Treatment:

Drug: LY2963016

LY2963016 U-100 Formulation (Reference)

Experimental group

Description:

LY2963016 reference formulation administered as a SC injection in one of two or two of four study periods.

Treatment:

Drug: LY2963016