Diabetes Mellitus, Type 2Phase 1NCT01436201

A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants

A Phase 1 study testing Digoxin and Dulaglutide in people with Diabetes Mellitus, Type 2, 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

The purpose of this study is to study how the body processes digoxin and the effect of dulaglutide on how digoxin is processed by the body. Information about any side effects that may occur will also be collected. This study is for research purposes only and is not intended to treat any medical condition. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Digoxin and Dulaglutide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Sep 2011to 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 65 years
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 participants 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 participant sterilization
True abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable)
Female participants not of child-bearing potential (that is, they are postmenopausal or permanently sterilized [such as, tubal occlusion, hysterectomy, bilateral salpingectomy]). Such participants will not be required to use contraception but must test negative for pregnancy at the time of enrolment. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) or at least 1 year of spontaneous amenorrhea, with follicle stimulating hormone (FSH) ≥40 milli-international units per milliliter (mIU/mL)

Show all 13Show fewer

Female participants 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 participants must also test negative for pregnancy at the time of enrolment
Have a body mass index (BMI) of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive, at screening
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 (potassium, magnesium, and calcium values must be within the normal range)
Have normal renal function defined as an estimated creatinine clearance (CrCl) of ≥80 milliliter per minute (mL/min)
Have venous access sufficient to allow for blood sampling
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study restrictions
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

Who cannot join

Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product, 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 glucagon like peptide-1 (GLP-1)-related compounds including dulaglutide (LY2189265) or to digoxin, related compounds or any components of either formulation
Are participants who have previously completed or withdrawn from this study or any other study investigating dulaglutide in the 3 months prior to screening or have received glucagon-like peptides or incretin mimetics in the 3 months prior to screening
Have an abnormality in the 12-lead electrocardiogram (ECG) (such as, first, second, or third degree atrioventricular [AV] block, prolonged corrected QT [QTc] interval, sinus tachycardia, sinus bradycardia, atrial fibrillation, or sinus node disease) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a history of significant dysrhythmias or AV block
Have an abnormal blood pressure (after at least 5 minutes sitting) that, in the opinion of the investigator, increases the risks associated with participating in the study

Show all 23Show fewer

Have a history or presence of cardiac, respiratory, hepatic, renal, endocrine (such as, hypothyroidism), hematological, or neurological disorders 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
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 (GE) (such as, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs. Participants with 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
Show evidence of significant active neuropsychiatric disease
Have family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) infection 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
Have used or intend to use over-the-counter medication other than acetaminophen within 7 days prior to dosing or prescription medication (with the exception of vitamin/mineral supplements) within 14 days prior to dosing, or have used St John's Wort within 14 days prior to dosing
Have donated blood of more than 500 mL within the month prior to screening
Have an average weekly alcohol intake that exceeds 21 units per week (males) 14 units per week (females), or are unwilling to stop alcohol consumption from screening through follow-up (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
Are smokers
Have a history of cancer with the past 20 years, with the exception of basal cell or squamous cell skin cancer, or treated cervical carcinoma in situ
Intend to consume grapefruit within 7 days prior to dosing
Are participants who, in the opinion of the investigator, are in any way unsuitable to participate in the study
Have any medical conditions, medical history or are taking any medication which are contraindicated

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.
Daytona Beach, Florida, 32117

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About this study

Official title: Effect of Dulaglutide (LY2189265) on the Pharmacokinetics of Digoxin in Healthy Subjects

This study is for research purposes only and is not intended to treat any medical condition. This research study requires that a blood sample be obtained and stored for future research involving genetic analysis.

Conditions: Diabetes Mellitus, Type 2
Being tested: Digoxin, Dulaglutide
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.

DigoxinDrug
Administered orally
DulaglutideBiological
Also called LY2189265
Administered as subcutaneous injection

Study groups in NCT01436201
Study group	Role	What they receive
Digoxin + Dulaglutide	Experimental	Digoxin: Two 0.5-milligram (mg) doses, oral, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, oral, once daily on Day 2 to Day 17. Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15. Receives: Drug: Digoxin; Biological: Dulaglutide

What is being measured

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

Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin
Measured: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin
Measured: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
Measured: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17

Timeline

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

Sep 2011Nov 2011

First posted19 Sep 2011 (estimated)
Study startSep 2011
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.
Publications (1)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01436201
Sponsor's protocol ID: 11550
Other IDs: H9X-MC-GBCR
Status last verified: Oct 2014
First submitted: 15 Sep 2011
Last updated: 7 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

de la Pena A, Cui X, Geiser J, Loghin C. No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. Clin Pharmacokinet. 2017 Nov;56(11):1415-1427. doi: 10.1007/s40262-017-0531-7.
PubMed 28357715

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: Effect of Dulaglutide (LY2189265) on the Pharmacokinetics of Digoxin in Healthy Subjects
ClinicalTrials.gov ID: NCT01436201
Acronym / sponsor ID: 11550
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 19 Sep 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Digoxin + Dulaglutide	Experimental	Drug: Digoxin, Biological: DulaglutideDigoxin: Two 0.5-milligram (mg) doses, oral, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, oral, once daily on Day 2 to Day 17. Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Are overtly healthy males or females, as determined by medical history and physical examination
Male participants 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:
Female participants not of child-bearing potential (that is, they are postmenopausal or permanently sterilized [such as, tubal occlusion, hysterectomy, bilateral salpingectomy]). Such participants will not be required to use contraception but must test negative for pregnancy at the time of enrolment. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) or at least 1 year of spontaneous amenorrhea, with follicle stimulating hormone (FSH) ≥40 milli-international units per milliliter (mIU/mL)
Female participants 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 participants must also test negative for pregnancy at the time of enrolment
Have a body mass index (BMI) of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive, at screening

Key exclusion criteria (23 listed)

Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product, 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 glucagon like peptide-1 (GLP-1)-related compounds including dulaglutide (LY2189265) or to digoxin, related compounds or any components of either formulation
Are participants who have previously completed or withdrawn from this study or any other study investigating dulaglutide in the 3 months prior to screening or have received glucagon-like peptides or incretin mimetics in the 3 months prior to screening
Have an abnormality in the 12-lead electrocardiogram (ECG) (such as, first, second, or third degree atrioventricular [AV] block, prolonged corrected QT [QTc] interval, sinus tachycardia, sinus bradycardia, atrial fibrillation, or sinus node disease) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a history of significant dysrhythmias or AV block

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
DigoxinAdministered orally	Drug	Digoxin + Dulaglutide
DulaglutideAlso: LY2189265Administered as subcutaneous injection	Biological	Digoxin + Dulaglutide

Primary outcome

Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin
Time frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin
Time frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
Time frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17

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
Digoxin + Dulaglutide	24	20

Primary outcome: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin

Time frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms times hours/milliliter

Measure	Digoxin Only n = 21	Digoxin + Dulaglutide n = 21
Day 7	16.8 (25)	NA (NA)
Day 10	NA (NA)	16.1 (26)
Day 17 (n=20)	NA (NA)	16.3 (32)

Population analysed: Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin AUC data.

Primary outcome: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin

Time frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter

Measure	Digoxin Only n = 21	Digoxin + Dulaglutide n = 21
Day 7	1.71 (27)	NA (NA)
Day 10	NA (NA)	1.34 (40)
Day 17 (n=20)	NA (NA)	1.42 (42)

Population analysed: Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Cmax data.

Primary outcome: Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin

Time frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17. Median (Full Range). Unit: hours

Measure	Digoxin Only n = 21	Digoxin + Dulaglutide n = 21
Day 7	1.00 (0.50 to 1.50)	NA (NA to NA)
Day 10	NA (NA to NA)	1.50 (1.00 to 6.00)
Day 17 (n=20)	NA (NA to NA)	1.50 (1.00 to 4.00)

Population analysed: Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Tmax data.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Digoxin	0 of 24 (0%)	13 of 24 (54.2%)	Not reported
Digoxin + Dulaglutide	0 of 21 (0%)	16 of 21 (76.2%)	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.
Derived from this study: PubMed 28357715de la Pena A, Cui X, Geiser J, Loghin C. No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. Clin Pharmacokinet. 2017 Nov;56(11):1415-1427. doi: 10.1007/s40262-017-0531-7.

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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 Digoxin and Dulaglutide in people with Diabetes Mellitus, Type 2, 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 13 inclusion and 23 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?

Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin (time frame: Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17). The study lists 3 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 NCT01436201, which also lists 1 linked publication.

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.