---
title: A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants
nct_id: NCT02955953
overall_status: COMPLETED
phase: PHASE1
sponsor: Eli Lilly and Company
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: Singapore
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02955953.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02955953"
ct_last_update_post_date: 2017-03-21
last_seen_at: "2026-05-12T06:25:42.513Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

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

**NCT ID:** [NCT02955953](https://clinicaltrials.gov/study/NCT02955953)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 127
- **Lead Sponsor:** Eli Lilly and Company
- **Conditions:** Healthy
- **Start Date:** 2016-11-14
- **Completion Date:** 2017-01-04
- **CT.gov Last Update:** 2017-03-21

## 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.

## Eligibility

- **Minimum age:** 21 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **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
```

## Arms

- **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.
- **LY2963016 U-100 Formulation (Reference)** (EXPERIMENTAL) — LY2963016 reference formulation administered as a SC injection in one of two or two of four study periods.

## Interventions

- **LY2963016** (DRUG) — Administered SC

## Primary Outcomes

- **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)_
- **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

- **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)_
- **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)_

## 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

## Recent Field Changes (last 30 days)

- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.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` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02955953.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02955953*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*