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CompletedNCT02955953Updated Mar 21, 2017

A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

A Phase 1 interventional study of LY2963016 in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in Singapore. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-21.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Browse Eli Lilly and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    LY2963016 U-200 Formulation (Test)

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

    Drug: LY2963016

  • Experimental
    LY2963016 U-100 Formulation (Reference)

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

    Drug: LY2963016

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • 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
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2016 to primary completion in Jan 2017, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2016
First posted
Nov 4, 2016
StartActual
Nov 14, 2016
Primary completionActual
Jan 4, 2017
CompletionActual
Jan 4, 2017
Last update
Mar 21, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02955953
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 4, 2016
Start date
Nov 14, 2016
Primary completion
Jan 4, 2017
Completion
Jan 4, 2017
Last update
Mar 21, 2017

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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