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Diabetes Mellitus, Type 2Phase 1NCT01324388

A Study of the Effect of LY2189265 on Two Blood Pressure Drugs

A Phase 1 study testing LY2189265, Metoprolol and Lisinopril in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 3 sites in United States.

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 purpose of this study is twofold: 1. To evaluate the effect of LY2189265 on how the body absorbs a blood pressure lowering drug (lisinopril) in participants with high blood pressure who are currently taking lisinopril. 2. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
LY2189265, Metoprolol and Lisinopril
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
3 sitesUnited States
Study dates
Mar 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

  • Male participants: agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product
  • Female participants: women not of child-bearing potential due to menopause or surgical sterilization (at least 6 weeks post surgical bilateral oophorectomy, hysterectomy or tubal ligation) confirmed by medical history
  • Have a body mass index (BMI) of 18.5 to 40.0 kilograms/square meter (kg/m^2), inclusive at the time of 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
  • Have venous access sufficient to allow for blood sampling as per the protocol
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study restrictions
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  • Have given written informed consent on an informed consent form (ICF) approved by Lilly and the corresponding ethics committee (EC) or ethical review board (ERB) governing the site
  • Part 1 only:
  • Have controlled mild to moderate hypertension (supine blood pressure [BP] less than or equal to 140/90 millimeter of mercury (mm Hg) at screening, or results with acceptable deviations that are judged not to be clinically significant by the investigator).
  • Males and females with stable medical problems (including Type 2 Diabetes Mellitus [T2DM]) that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data may be included
  • Have been on oral antihypertensive medication (lisinopril daily [QD]) for at least 3 months prior to screening, have been on a stable dose for at least 1 month prior to screening, and are, in the investigator's opinion, able to safely adhere to a QD morning dosing regimen. Additional medication may be permitted as indicated
  • T2DM Participants (Part 1 only):
  • Have T2DM controlled with diet or exercise alone or 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 hemoglobin A1c (HbA1c) value of 6.0% to 9.5% at screening or within 4 weeks prior to screening
  • 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
  • Part 2 only:
  • Are overtly healthy, as determined by medical history and physical examination

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 LY2189265, or any components of the formulation
  • Are participants who have previously completed or withdrawn from this study, or have taken part in any other study investigating LY2189265 or GLP-1-related compounds within the last 3 months
  • 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) (e.g. gastric bypass surgery, pyloric stenosis) or could be aggravated by GLP-1 analogs (for example; esophageal reflux). Participants having had 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
  • Have a history or presence of thyroid disease, unless have been on a stable dose of thyroxine replacement therapy for at least 1 month
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  • Show history or evidence of significant active neuropsychiatric disease
  • Have personal or 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
  • Intend to start new concomitant medication during the study, including over-the-counter and herbal medication, use drugs that directly reduce gastrointestinal motility or who regularly use systemic corticosteroids, or potent, inhaled, or intranasal steroids known to have a high rate of systemic absorption
  • Have donated more than 500 milliliters (mL) of blood within the month prior to screening
  • Have a nondominant arm circumference of greater than 42 centimeters (cm)
  • Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption from 48 hours before each admission until discharge from the unit, and to limit alcohol intake to a maximum of 2 units/day on all other days from screening through 48 hours prior to the follow-up visit. (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 participants who, in the opinion of the investigator, are in any way unsuitable to participate in the study
  • Part 1 only:
  • Have any medical conditions, medical history or are taking any medication which are contraindicated within the lisinopril product information leaflet
  • Part 2 only:
  • Intend to use over-the-counter medication (with the exception of paracetamol and/or antacids) 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 of the investigational product
  • Have any medical conditions, medical history or are taking any medication which are contraindicated within the metoprolol product information leaflet

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • 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.

    Dallas, Texas, 75247

  • 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, 47710

  • 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.

    Honolulu, Hawaii, 96813

Other trials in United States

About this study

Official title: Pharmacokinetic and Pharmacodynamic Effect of LY2189265 on Lisinopril in Subjects With Hypertension and Metoprolol in Healthy Subjects

The purpose of this study is twofold:

  1. To evaluate the effect of LY2189265 on how the body absorbs a blood pressure lowering drug (lisinopril) in participants with high blood pressure who are currently taking lisinopril.
  2. To evaluate the effect of LY2189265 on heart rate and blood pressure in healthy volunteers when taken with a Beta-blocker drug (metoprolol).

In Part 1, participants will receive four weekly injections of LY2189265 with continued use of normal lisinopril therapy.

Part 2 is a cross-over study design. Participants will receive a single injection of LY2189265 in one period, and seven daily doses of metoprolol and a single injection of LY2189265 in another period.

Being tested
LY2189265, Metoprolol, Lisinopril, Placebo
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

    Also called dulaglutide

    Administered subcutaneously

  • MetoprololDrug

    Administered orally

  • LisinoprilDrug

    Administered orally

  • PlaceboDrug

    Administered subcutaneously

Study groups in NCT01324388
Study groupRoleWhat they receive
LY2189265 + LisinoprilExperimentalLY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study. Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
Receives: Biological: LY2189265; Drug: Lisinopril
Placebo + LisinoprilPlacebo comparatorPlacebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study. Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study.
Receives: Drug: Lisinopril; Drug: Placebo
LY2189265 (Treatment 1)/Metoprolol + LY2189265 (Treatment 2)ExperimentalLY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 and on Day 5 of Treatment 2 in Part 2 of the study. Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study. There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 of Treatment 1 to Day 1 of Treatment 2 in Part 2 of the study).
Receives: Biological: LY2189265; Drug: Metoprolol
Metoprolol + LY2189265 (Treatment 2)/LY2189265 (Treatment 1)ExperimentalLY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 and on Day 1 of Treatment 1 in Part 2 of the study. Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study. There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 7 of Treatment 2 to Day 1 of Treatment 1 in Part 2 of the study).
Receives: Biological: LY2189265; Drug: Metoprolol

What is being measured

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

  1. Pharmacokinetics, Area Under the Concentration Curve (AUC) of Lisinopril

    Measured: Day -1, Day 3, Day 24 of Part 1

  2. Pharmacokinetics, Maximum Concentration (Cmax) of Lisinopril

    Measured: Day -1, Day 3, Day 24 in Part 1

  3. Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol

    Measured: Day -1, Day 4, Day 7 of Treatment 2 in Part 2

  4. Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol

    Measured: Day -1, Day 4, Day 7 of Treatment 2 in Part 2

Secondary outcomes (4)

  1. Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril

    Measured: Day -1, Day 3, Day 24 of Part 1

  2. Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril

    Measured: Day -1, Day 3, Day 24 of Part 1

  3. Pharmacokinetics, Area Under the Concentration Curve (AUC) of Metoprolol When Administered With LY2189265

    Measured: Day 4 and Day 7 of Treatment 2 in Part 2

  4. Pharmacokinetics, Maximum Concentration (Cmax) of Metoprolol When Administered With LY2189265

    Measured: Day 4 and Day 7 of Treatment 2 in Part 2

Timeline

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

  1. First posted29 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01324388
Sponsor's protocol ID
11552
Other IDs
H9X-MC-GBCO
Status last verified
Oct 2014
First submitted
25 Mar 2011
Last updated
8 Oct 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2189265, Metoprolol and Lisinopril in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 3 sites 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 17 inclusion and 22 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 8 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 3 sites 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. Some participants in this study may receive a placebo. 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 8 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 Curve (AUC) of Lisinopril (time frame: Day -1, Day 3, Day 24 of Part 1). The study lists 4 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 NCT01324388.

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 8 Oct 2014.

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