A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

NCT02955953 | Completed Phase 1

• 2 other identifiers: 16249I4L-MC-ABEV
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

LY2963016 U-200 Formulation (Test)

EXPERIMENTAL

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

Drug: LY2963016

LY2963016 U-100 Formulation (Reference)

EXPERIMENTAL

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

Drug: LY2963016

Interventions

LY2963016 DRUG

Administered SC

LY2963016 U-100 Formulation (Reference); LY2963016 U-200 Formulation (Test)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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

Location

MeSH Terms

Interventions

LY2963016 insulin glargine

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 4, 2016
• Study Start: November 14, 2016
• Primary Completion: January 4, 2017
• Study Completion: January 4, 2017
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

SG (1)