Diabetes MellitusPhase 1NCT01374178

A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects

A Phase 1 study testing LY2963016 and Lantus in people with Diabetes Mellitus, run by Eli Lilly and Company at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks. Read more about this study

Who is it for?: Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus
What is being tested?: LY2963016 and Lantus
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteSingapore
Study dates: Jun 2011to Jul 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Are overtly healthy males or females
Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)
Are nonsmokers
Have normal blood pressure and pulse rate
Have an electrocardiogram (ECG) considered as within normal limits
Have clinical laboratory test results within normal reference range

Who cannot join

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device
Have known allergies to insulin or its excipients
Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
Show evidence of significant active neuropsychiatric disease
Have a history of first-degree relatives known to have diabetes mellitus
Have a fasting venous blood glucose >6.0 millimoles per liter (mmol/L)

Show all 9Show fewer

Intend to use over-the-counter or prescription medication
Have donated or had a blood loss of 450 milliliters (mL) or more in the past 3 months
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Singapore

Other trials in Singapore

About this study

Official title: Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects

Conditions: Diabetes Mellitus
Being tested: LY2963016, Lantus
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2963016Drug
Administered subcutaneously
LantusDrug
Also called Insulin Glargine
Administered subcutaneously

Study groups in NCT01374178
Study group	Role	What they receive
LY2963016	Experimental	A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously. Receives: Drug: LY2963016
Lantus	Active comparator	A single 0.5-U/kg dose of Lantus will be administered subcutaneously. Receives: Drug: Lantus

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)
AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.
Measured: Periods 1 and 2: Baseline up to 24 hours

Secondary outcomes (5)

Pharmacokinetics: Maximum Concentration (Cmax)
Measured: Periods 1 and 2: Baseline up to 24 hours
Maximum Glucose Infusion Rate (Rmax)
Measured: Periods 1 and 2: Baseline up to 24 hours
Total Glucose Infused (Gtot)
Measured: Periods 1 and 2: Baseline up to 24 hours
Time of Maximum Glucose Infusion Rate (tRmax)
Measured: Periods 1 and 2: Baseline up to 24 hours
Number of Participants With Clinically Significant Effects
Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module.
Measured: Baseline up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jul 2011

First posted15 Jun 2011 (estimated)
Study startJun 2011
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01374178
Sponsor's protocol ID: 14094
Other IDs: I4L-MC-ABEI
Status last verified: Oct 2014
First submitted: 13 Jun 2011
Last updated: 7 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects
ClinicalTrials.gov ID: NCT01374178
Acronym / sponsor ID: 14094
Conditions: Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 15 Jun 2011 (estimated)
Results: Posted 7 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LY2963016	Experimental	Drug: LY2963016A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously.
Lantus	Active comparator	Drug: LantusA single 0.5-U/kg dose of Lantus will be administered subcutaneously.

Who may qualify

Ages: 21 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Are overtly healthy males or females
Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)
Are nonsmokers
Have normal blood pressure and pulse rate
Have an electrocardiogram (ECG) considered as within normal limits

Key exclusion criteria (9 listed)

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device
Have known allergies to insulin or its excipients
Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
Show evidence of significant active neuropsychiatric disease
Have a history of first-degree relatives known to have diabetes mellitus

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 subcutaneously	Drug	LY2963016
LantusAlso: Insulin GlargineAdministered subcutaneously	Drug	Lantus

Primary outcome

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)
Time frame: Periods 1 and 2: Baseline up to 24 hours
AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.

5 secondary outcomes

Pharmacokinetics: Maximum Concentration (Cmax)
Time frame: Periods 1 and 2: Baseline up to 24 hours
Maximum Glucose Infusion Rate (Rmax)
Time frame: Periods 1 and 2: Baseline up to 24 hours
Total Glucose Infused (Gtot)
Time frame: Periods 1 and 2: Baseline up to 24 hours
Time of Maximum Glucose Infusion Rate (tRmax)
Time frame: Periods 1 and 2: Baseline up to 24 hours
Number of Participants With Clinically Significant Effects
Time frame: Baseline up to 30 days

Results and safety

Results posted to the registry on 7 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2963016 First, Then Lantus	11	11
Lantus First, Then LY2963016	5	5

Primary outcome: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)

Time frame: Periods 1 and 2: Baseline up to 24 hours. Geometric mean (Geometric Coefficient of Variation). Unit: picomole*hour per liter (pmol*hr/L)

Measure	LY2963016 n = 16	Lantus n = 13
Value	1900 (22)	2180 (30)

Population analysed: All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2963016	0 of 16 (0%)	8 of 16 (50%)	Not reported
Lantus	0 of 13 (0%)	6 of 13 (46.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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 and Lantus in people with Diabetes Mellitus, 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 6 inclusion and 9 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 7 Oct 2014. 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?

Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: Area Under the Concentration-Time Curve (AUC) (time frame: Periods 1 and 2: Baseline up to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01374178.

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 7 Oct 2014; AzTrials last refreshed its copy on 7 Nov 2026.