Diabetes Mellitus, Type IIPhase 1NCT01301092

A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.

A Phase 1 study testing LY2189265 in people with Diabetes Mellitus, Type II, run by Eli Lilly and Company at 1 site in United States.

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type II
What is being tested?: LY2189265
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Feb 2011to Aug 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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Are overtly healthy males or females, as determined by medical history and physical examination.
Male subjects with female partners of child-bearing potential, or partners who are pregnant or breastfeeding, agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator. The method may be one of the following: condom with spermicidal agent, male subject sterilization, true abstinence (which is in line with the subject's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable).
Female subjects not of child-bearing potential (that is, are postmenopausal or permanently sterilized [for example, tubal occlusion, hysterectomy, bilateral salpingectomy]). Such subjects will not be required to use contraception but must test negative for pregnancy at the time of enrollment. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) with follicle stimulating hormone (FSH) greater than or equal to 40 milli-international units per milliliter (mIU/mL).
Female subjects who have undergone sterilization by tubal ligation: agree to use a condom in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of investigational product. Such subjects must also test negative for pregnancy at the time of enrollment.
Have a body mass index (BMI) of between 23.0 and 35.0 kilogram/square meter (kg/m²), inclusive.
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.

Show all 10Show fewer

Have normal sitting blood pressure and pulse rate as determined by the investigator, or with changes compatible with their age.
Have venous access sufficient to allow for blood sampling and/or IV administration of investigational product as per the protocol.
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.

Who cannot join

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Are women of child bearing potential
Have known allergies to Glucagon-like peptide-1 (GLP-1)-related compounds including LY2189265.
Are persons who have previously completed or withdrawn from this study or any other study investigating LY2189265.
Have an abnormality in the 12-lead Electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
Have a history or presence of gastrointestinal disorder (including pancreatitis [history of chronic pancreatitis or idiopathic acute pancreatitis] or gall bladder disease), or gastrointestinal disease that impacts gastric emptying (GE) (for example, gastric bypass surgery, pyloric stenosis) or could be aggravated by GLP analogs (for example, esophageal reflux). Subjects having had cholecystolithiasis (removal of gall stones), cholecystectomy (removal of gall bladder) and/or appendectomy in the past with no further sequelae may be included in the study at the discretion of the screening physician.

Show all 17Show fewer

Have a history or presence of significant active neuropsychiatric disease
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
Show evidence of hepatitis C and/or positive hepatitis C antibody.
Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
Are women with a positive pregnancy test or women who are lactating.
Use or intend to use over-the-counter medication other than paracetamol within 7 days prior to dosing or prescription medication (with the exception of vitamin/mineral supplements and/or hormone replacement therapy and/or thyroid replacement therapy) within 14 days prior to dosing.
Have donated blood of more than 500 mL within the last month.
Are subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), (1 unit = 12 ounce [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits), or are unwilling to stop alcohol consumption from at least 24 hours prior to screening and each dose, and while resident at the clinical research unit (CRU).
Are subjects who smoke more than 10 cigarettes per day, are unwilling to refrain from smoking on the day of LY2189265 administration and while resident.
Are subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study.

Trial locations and contacts

1 site in 1 country.

United States1 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.
Evansville, Indiana

Other trials in United States

About this study

Official title: A Study to Evaluate the Safety, Tolerability, and Absolute Bioavailability of Subcutaneous LY2189265

LY2189265 is an investigational drug being developed for the treatment of type 2 diabetes mellitus. This study will compare the concentrations of LY2189265 using different methods of administration: subcutaneous (or SC- an injection just under the skin), intravenous (or IV - into a vein in the arm) and intramuscular (IM - into the muscle of the left thigh). The purpose of this study is to look at how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given by the methods above. The study is divided into three parts, Part A, B and C. Volunteers will only be able to participate in one part. All Participants in Part A will receive a single IV dose of up to 0.1 milligram (mg). Participants in Part B will be given drug twice by IV and an SC injection (1.5 mg). Part B of the study will occur after Part A because the dose of IV drug will depend on the results of Part A. Part B of the study may not occur if the volunteers in Part A do not tolerate the drug. Participants in Part C will also be given drug twice by an SC injection and an IM injection, both doses will be 0.75 mg.

Conditions: Diabetes Mellitus, Type II
Being tested: LY2189265
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

LY2189265Biological
administered intravenous, subcutaneous or intramuscular

Study groups in NCT01301092
Study group	Role	What they receive
Part A: LY2189265 intravenous	Experimental	Single intravenous (IV) dose, starting at 0.1 milligrams (mg) of LY2189265. Dose may be increased to 0.2 mg or decreased to 0.05 mg for subsequent patients, dependent on safety assessments of the first 3 patients. Receives: Biological: LY2189265
Part B: LY2189265 subcutaneous, intravenous	Experimental	Patients are randomized to 2 sequences of 2 treatments. Single 1.5 mg subcutaneous (SC) dose of LY2189265 in Period 1; single intravenous (IV) dose of LY2189265 (determined by Part A IV arm data) in Period 2 or vice versa. There is a washout period of at least 4 weeks between dosing periods. Receives: Biological: LY2189265
Part C: LY2189265 subcutaneous, intramuscular	Experimental	Patients are randomized to 2 sequences of 2 treatments. Single 0.75 mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75 mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There is a washout period of at least 4 weeks between dosing periods. Receives: Biological: LY2189265

What is being measured

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

Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Measured: Predose up to 336 hours postdose
Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Measured: Predose up to 336 hours postdose

Secondary outcomes (2)

Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Measured: Predose up to 336 hours postdose
)Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Measured: Predose up to 336 hours postdose

Timeline

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

Feb 2011Aug 2011

First posted23 Feb 2011 (estimated)
Study startFeb 2011
Primary completionAug 2011
Study completionAug 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 Mellitus, Type IIStudies 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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01301092
Sponsor's protocol ID: 13989
Other IDs: H9X-MC-GBDR
Status last verified: Oct 2014
First submitted: 18 Feb 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?

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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: A Study to Evaluate the Safety, Tolerability, and Absolute Bioavailability of Subcutaneous LY2189265
ClinicalTrials.gov ID: NCT01301092
Acronym / sponsor ID: 13989
Conditions: Diabetes Mellitus, Type II
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 23 Feb 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: 3

Arm	Type	Receives
Part A: LY2189265 intravenous	Experimental	Biological: LY2189265Single intravenous (IV) dose, starting at 0.1 milligrams (mg) of LY2189265. Dose may be increased to 0.2 mg or decreased to 0.05 mg for subsequent patients, dependent on safety assessments of the first 3 patients.
Part B: LY2189265 subcutaneous, intravenous	Experimental	Biological: LY2189265Patients are randomized to 2 sequences of 2 treatments. Single 1.5 mg subcutaneous (SC) dose of LY2189265 in Period 1; single intravenous (IV) dose of LY2189265 (determined by Part A IV arm data) in Period 2 or vice versa. There is a washout period of at least 4 weeks between dosing periods.
Part C: LY2189265 subcutaneous, intramuscular	Experimental	Biological: LY2189265Patients are randomized to 2 sequences of 2 treatments. Single 0.75 mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75 mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There is a washout period of at least 4 weeks between dosing periods.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Are overtly healthy males or females, as determined by medical history and physical examination.
Male subjects with female partners of child-bearing potential, or partners who are pregnant or breastfeeding, agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator. The method may be one of the following: condom with spermicidal agent, male subject sterilization, true abstinence (which is in line with the subject's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable).
Female subjects not of child-bearing potential (that is, are postmenopausal or permanently sterilized [for example, tubal occlusion, hysterectomy, bilateral salpingectomy]). Such subjects will not be required to use contraception but must test negative for pregnancy at the time of enrollment. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) with follicle stimulating hormone (FSH) greater than or equal to 40 milli-international units per milliliter (mIU/mL).
Female subjects who have undergone sterilization by tubal ligation: agree to use a condom in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of investigational product. Such subjects must also test negative for pregnancy at the time of enrollment.
Have a body mass index (BMI) of between 23.0 and 35.0 kilogram/square meter (kg/m²), inclusive.

Key exclusion criteria (17 listed)

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Are women of child bearing potential
Have known allergies to Glucagon-like peptide-1 (GLP-1)-related compounds including LY2189265.
Are persons who have previously completed or withdrawn from this study or any other study investigating LY2189265.
Have an abnormality in the 12-lead Electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.

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
LY2189265administered intravenous, subcutaneous or intramuscular	Biological	Part A: LY2189265 intravenous, Part B: LY2189265 subcutaneous, intravenous, Part C: LY2189265 subcutaneous, intramuscular

Primary outcome

Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
Time frame: Predose up to 336 hours postdose
AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
Time frame: Predose up to 336 hours postdose
The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.

2 secondary outcomes

Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
Time frame: Predose up to 336 hours postdose
)Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
Time frame: Predose up to 336 hours postdose

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
Part A: LY2189265 Intravenous	6	6
Part B: LY2189265 Subcutaneous, Intravenous	16	16
Part C: LY2189265 Subcutaneous, Intramuscular	8	7

Primary outcome: Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)

Time frame: Predose up to 336 hours postdose. Geometric mean (90% Confidence Interval). Unit: nanograms*hour/milliliter/milligram

Measure	Part B: LY2189265 Subcutaneous n = 16	Part B: LY2189265 Intravenous n = 16
Value	10256 (8964 to 11734)	23150 (20234 to 26485)

Part B: LY2189265 Subcutaneous vs Part B: LY2189265 Intravenous: Ratio of Geometric LS Mean: 0.443 (90% CI 0.395 to 0.497), Mixed Linear effects model analyses

Population analysed: Participants in Part B who had pharmacokinetic (PK) data.

Primary outcome: Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)

Time frame: Predose up to 336 hours postdose. Geometric mean (90% Confidence Interval). Unit: nanograms/milliliter (ng/mL)

Measure	Part B: LY2189265 Subcutaneous n = 16	Part B: LY2189265 Intravenous n = 16
Value	80.7 (71.8 to 90.8)	38.3 (34.1 to 43.1)

Part B: LY2189265 Subcutaneous vs Part B: LY2189265 Intravenous: Ratio of Geometric LS Mean: 2.10 (90% CI 1.84 to 2.41), Mixed Linear effects model analyses

Population analysed: Participants in Part B who had pharmacokinetic (PK) data.

2 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
Part A: 0.1 mg IV LY2189265	0 of 6 (0%)	0 of 6 (0%)	Not reported
Part B: 0.1 mg IV LY2189265	0 of 16 (0%)	7 of 16 (43.8%)	Not reported
Part B: 1.5 mg SC LY2189265	0 of 16 (0%)	9 of 16 (56.3%)	Not reported
Part C: 0.75 mg IM LY2189265	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Part C: 0.75 mg SC LY2189265	0 of 8 (0%)	2 of 8 (25%)	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.

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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 LY2189265 in people with Diabetes Mellitus, Type II, run by Eli Lilly and Company at 1 site in United States.

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 10 inclusion and 17 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 United States. 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?

Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV) (time frame: Predose up to 336 hours postdose). 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?

On the ClinicalTrials.gov record for NCT01301092.

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.