Diabetes Mellitus, Type 2Phase 1NCT01253304

A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment

A Phase 1 study testing LY2189265 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The primary purpose of this study is to help answer the following research questions, and not to provide treatment for any condition: To evaluate how much of the study drug (LY2189265) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
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: 26 participants
Where: 2 sitesin 2 countries
Study dates: Nov 2010to Nov 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 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All Participants (including participants with type 2 diabetes mellitus [T2DM]):
Male participants - Agree to use a reliable method of birth control (for example, barrier methods) during the study and for at least 3 months following dosing of study drug
Female participants:
Women must be of non-child-bearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause
Women with an intact uterus are deemed postmenopausal if they are over 45 years old and have had cessation of menses for at least 1 year or have had 6 to 12 months of spontaneous amenorrhea with follicle stimulating hormone (FSH) >40 international units per milliliter (IU/mL) and have not taken hormone replacement therapy or oral contraceptives within 1 year of study start and are otherwise healthy
Women who have had cessation of menses for at least 2 years are permitted to take hormone replacement therapy

Show all 23Show fewer

Have a body mass index (BMI) between 19.0 and 40.0 kilograms per meters squared (kg/m^2), inclusive, at screening.
Have venous access sufficient to allow blood sampling
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 governing the site
Control Participants:
Overtly healthy participants with normal hepatic function
Participants with T2DM with normal hepatic function
Have normal sitting blood pressure and pulse rate as determined by the investigator or with changes compatible with their age and disease status in case of patients with T2DM
Have clinical laboratory test results within normal reference range for the investigator site or results with minor deviations not considered to be clinically significant by the investigator or with changes compatible with their age and disease status in case of T2DM
Hepatic Impaired Participants:
Have stable hepatic impairment (such as, post-alcoholic, chronic hepatitis, biliary cirrhosis, or cryptogenic) classified as Child-Pugh Class A, B, or C (mild, moderate, and severe impairment) who are considered by the investigator as acceptable for participation in the study. The hepatic-impaired participant population may include patients with T2DM.
Have sitting blood pressure and pulse rate compatible with their disease state [including T2DM, if applicable] as determined by the investigator.
Participants with T2DM (All Study Groups)
Have T2DM controlled with diet and exercise alone or T2DM is stable on a single, oral agent antihyperglycemic medication (metformin, sulfonylureas, repaglinide, nateglinide, acarbose [or other disaccharidase inhibitors], or thiazolidinediones) for at least 3 weeks (3 months for thiazolidinediones) prior to admission
Have a glycosylated hemoglobin (HbA1C) value at screening (or within 4 weeks prior to screening) of 6.5% to 9.0%
Have clinical laboratory test results within normal range or deemed clinically insignificant by the investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable
Have acceptable blood pressure and pulse rate (sitting), as determined by the investigator

Who cannot join

All participants (including participants with T2DM)
Are currently enrolled in, discontinued within the last 30 days from a clinical trial involving use of an investigational drug or device other than the study drug, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have known allergies to LY2189265 or related compounds
Have previously completed or withdrawn from this study or any other study investigating LY2189265
Have a current, functioning organ transplant
Show evidence of significant active, uncontrolled, endocrine or autoimmune abnormalities (such as, thyroid disease or pernicious anemia) as judged by the screening physician

Show all 41Show fewer

Have shown febrile illness within 3 days prior to screening
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
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening that are not otherwise explained by permitted concomitant medications
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
Are women with a positive pregnancy test or women who are lactating
Have donated blood of more than 500 milliliters (mL) within the last month prior to screening
Have an average weekly alcohol intake that exceeds 21 units per week (men) and 14 units per week (women) (1 unit = 12 ounces [oz] or 360 mL of beer, 5 oz or 150 mL of wine, or 1.5 oz or 45 mL of distilled spirits)
Are unwilling to stop alcohol consumption for the duration of the study (from screening until the follow-up visit)
Are participants who smoke more than 10 cigarettes per day, are unwilling to refrain from smoking on the day of LY2189265 administration, or are unable to abide by clinical research unit (CRU) restrictions on other inpatient days
Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder, (for example relevant esophageal reflux or gall bladder disease, or any gastrointestinal disease which impacts gastric emptying [such as, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy] or could be aggravated by glucagon like peptide [GLP] analogs). Participants with mild hypertension and dyslipidemia, and participants who had cholecystolithiasis (removal of gall stones) and/or cholecystectomy (removal of gall bladder) in the past, with no further sequelae, may be included in the study at the discretion of the screening physician.
Are participants deemed to be unsuitable by the investigator for any reason.
Control participants:
Have a history or presence of cardiovascular (such as, myocardial infarction, cerebrovascular accident, venous thromboembolism), respiratory, renal, endocrine (with exception of participants with T2DM), hematological, neurological disorders, cancer, hepatic (including Gilbert's disease), or dermatological disorders or diseases capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Show evidence of significant active neuropsychiatric disease
Have creatinine clearance less than 80 milliliters per minute (mL/min) (as calculated by the Cockcroft-Gault equation)
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Show evidence of hepatitis C and/or positive hepatitis C antibody
Intend to use:
Over-the-counter medication (including herbal remedies/health supplements) within 7 days prior to dosing
Prescription medication within 14 days prior to dosing participants with mild, moderate, and severe hepatic impairment
Show evidence of any significant active disease other than that responsible for or associated with hepatic impairment. Participants with hypertension and hyperlipidemia may be permitted at the investigator's discretion.
Show, in the opinion of the investigator, evidence of significant neuropsychiatric disease other than Grade 1 hepatic encephalopathy
Show evidence of spontaneous bacterial peritonitis within 6 months of dosing.
Show evidence of severe hyponatremia (Sodium [Na] <120 millimoles per liter [mmol/L])
Show presence of hepatocellular carcinoma
Have a portal shunt
Show evidence of severe ascites
Have hemoglobin <9.0 grams per deciliter (g/dL)
Have platelet count <40 x 10^9 cells per liter (cells/L)
Have total serum bilirubin >15 milligrams per deciliter (mg/dL)
Use medication known to interfere with hepatic metabolism (that is, barbiturates, phenothiazines) or known to alter other major organs or systems
Mild, Hepatic Impaired Participants (Child-Pugh A)
Show evidence of active renal disease with creatinine clearance <70 mL/min calculated by the Cockcroft-Gault equation.
Moderate and Severe Hepatic Impaired Subjects (Child-Pugh B and C)
Show evidence of hepatorenal syndrome as shown by creatinine clearance <50 mL/min calculated by the Cockcroft-Gault equation.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Germany1 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.
Munich, 81241

Other trials in Germany

Hungary1 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.
Budapest, 1032

Other trials in Hungary

About this study

Official title: A Single Dose Pharmacokinetic Study of LY2189265 in Subjects With Varying Degrees of Hepatic Impairment

The primary purpose of this study is to help answer the following research questions, and not to provide treatment for any condition:

To evaluate how much of the study drug (LY2189265) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function.
To assess the safety of LY2189265 and any side effects that might be associated with it.

Conditions: Diabetes Mellitus, Type 2
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.

LY2189265Drug
Also called Dulaglutide
Subcutaneous (SC) injection

Study groups in NCT01253304
Study group	Role	What they receive
Normal hepatic function	Experimental	LY2189265: A single, subcutaneous (SC) 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function Receives: Drug: LY2189265
Mild hepatic impairment	Experimental	LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A) Receives: Drug: LY2189265
Moderate hepatic impairment	Experimental	LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B) Receives: Drug: LY2189265
Severe hepatic impairment	Experimental	LY2189265: A single, SC-1.5 mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C) Receives: Drug: LY2189265

What is being measured

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

Pharmacokinetics: Maximum Observed Concentration (Cmax)
This measure was calculated using non-compartmental analysis techniques.
Measured: Predose to 336 hours postdose
Pharmacokinetics: Time of Maximum Concentration (Tmax)
This measure was calculated using non-compartmental analysis techniques.
Measured: Predose to 336 hours postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])
This measure was calculated using non-compartmental analysis techniques.
Measured: Predose to 336 hours postdose
Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])
This measure was calculated using non-compartmental analysis techniques.
Measured: Predose to 336 hours postdose
Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)
The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques.
Measured: Predose to 336 hours postdose
Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)
The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.
Measured: Predose to 336 hours postdose
Pharmacokinetics: Apparent Volume of Distribution (Vz/F)
The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.
Measured: Predose 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.

Nov 2010Nov 2011

First posted3 Dec 2010 (estimated)
Study startNov 2010
Primary completionNov 2011
Study completionNov 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 2Studies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01253304
Sponsor's protocol ID: 13765
Other IDs: H9X-EW-GBDO
Status last verified: Oct 2014
First submitted: 1 Dec 2010
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 Single Dose Pharmacokinetic Study of LY2189265 in Subjects With Varying Degrees of Hepatic Impairment
ClinicalTrials.gov ID: NCT01253304
Acronym / sponsor ID: 13765
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 3 Dec 2010 (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.

The primary purpose of this study is to help answer the following research questions, and not to provide treatment for any condition:

To evaluate how much of the study drug (LY2189265) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function.
To assess the safety of LY2189265 and any side effects that might be associated with it.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Normal hepatic function	Experimental	Drug: LY2189265LY2189265: A single, subcutaneous (SC) 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
Mild hepatic impairment	Experimental	Drug: LY2189265LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
Moderate hepatic impairment	Experimental	Drug: LY2189265LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
Severe hepatic impairment	Experimental	Drug: LY2189265LY2189265: A single, SC-1.5 mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Male participants - Agree to use a reliable method of birth control (for example, barrier methods) during the study and for at least 3 months following dosing of study drug
Female participants:
Have a body mass index (BMI) between 19.0 and 40.0 kilograms per meters squared (kg/m^2), inclusive, at screening.
Have venous access sufficient to allow blood sampling
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Key exclusion criteria (41 listed)

All participants (including participants with T2DM)
Are currently enrolled in, discontinued within the last 30 days from a clinical trial involving use of an investigational drug or device other than the study drug, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have known allergies to LY2189265 or related compounds
Have previously completed or withdrawn from this study or any other study investigating LY2189265
Have a current, functioning organ transplant

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
LY2189265Also: DulaglutideSubcutaneous (SC) injection	Drug	Mild hepatic impairment, Moderate hepatic impairment, Normal hepatic function, Severe hepatic impairment

Primary outcome

Pharmacokinetics: Maximum Observed Concentration (Cmax)
Time frame: Predose to 336 hours postdose
This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: Time of Maximum Concentration (Tmax)
Time frame: Predose to 336 hours postdose
This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])
Time frame: Predose to 336 hours postdose
This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])
Time frame: Predose to 336 hours postdose
This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)
Time frame: Predose to 336 hours postdose
The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)
Time frame: Predose to 336 hours postdose
The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.
Pharmacokinetics: Apparent Volume of Distribution (Vz/F)
Time frame: Predose to 336 hours postdose
The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.

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
Normal Hepatic Function	11	11
Mild Hepatic Impairment	6	6
Moderate Hepatic Impairment	6	6
Severe Hepatic Impairment	3	2

Primary outcome: Pharmacokinetics: Maximum Observed Concentration (Cmax)

Time frame: Predose to 336 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms/milliliter (ng/mL)

Measure	Normal Hepatic Function n = 11	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 3
Value	84.5 (29)	63.0 (30)	58.1 (28)	61.3 (18)

Population analysed: Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.

Primary outcome: Pharmacokinetics: Time of Maximum Concentration (Tmax)

Time frame: Predose to 336 hours postdose. Median (Full Range). Unit: hours

Measure	Normal Hepatic Function n = 11	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 3
Value	48.00 (24.02 to 72.02)	48.01 (47.95 to 72.02)	59.96 (47.10 to 95.97)	71.93 (71.90 to 71.98)

Population analysed: Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.

Primary outcome: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])

Time frame: Predose to 336 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms times hour/milliliter(ng*hr/mL

Measure	Normal Hepatic Function n = 11	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 3
Value	10200 (26)	7670 (27)	7220 (19)	7660 (13)

Population analysed: Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.

Primary outcome: Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])

Time frame: Predose to 336 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms times hr/milliliter (ng*hr/mL)

Measure	Normal Hepatic Function n = 11	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 5	Severe Hepatic Impairment n = 3
Value	16300 (24)	12200 (26)	11200 (14)	12500 (5)

Population analysed: Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Hepatic Function	0 of 11 (0%)	10 of 11 (90.9%)	Not reported
Mild Hepatic Impairment	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Moderate Hepatic Impairment	1 of 6 (16.7%)	5 of 6 (83.3%)	Not reported
Severe Hepatic Impairment	1 of 3 (33.3%)	1 of 3 (33.3%)	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

2 sites in 2 countries: 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 2, run by Eli Lilly and Company at 2 sites in 2 countries.

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 23 inclusion and 41 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 2 sites in Germany, Hungary. 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: Maximum Observed Concentration (Cmax) (time frame: Predose to 336 hours postdose). The study lists 7 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 NCT01253304.

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.