HealthyPhase 1NCT02955953
A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants
A Phase 1 study testing LY2963016 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY2963016
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Nov 2016to 4 Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Singapore1 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
About this study
Official title: Bioequivalence Study Comparing the Pharmacokinetics and Glucodynamics of LY2963016 U-200 Formulation With LY2963016 U-100 Formulation in Healthy Subjects
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
- Being tested
- LY2963016
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2963016Drug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: LY2963016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation
Measured: 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
Measured: 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
Measured: 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
Measured: One hour before dosing up to about 30 hours post clamp procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start14 Nov 2016
- Primary completion4 Jan 2017
- Study completion4 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955953
- Sponsor's protocol ID
- 16249
- Other IDs
- I4L-MC-ABEV
- Status last verified
- Mar 2017
- First submitted
- 3 Nov 2016
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study Comparing the Pharmacokinetics and Glucodynamics of LY2963016 U-200 Formulation With LY2963016 U-100 Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02955953
- Acronym / sponsor ID
- 16249
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2963016 U-200 Formulation (Test) | Experimental | Drug: LY2963016LY2963016 test formulation administered as a subcutaneous (SC) injection in one of two or two of four study periods. |
| LY2963016 U-100 Formulation (Reference) | Experimental | Drug: LY2963016LY2963016 reference formulation administered as a SC injection in one of two or two of four study periods. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2963016Administered SC | Drug | LY2963016 U-100 Formulation (Reference), LY2963016 U-200 Formulation (Test) |
Primary outcome
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
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2963016 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.