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Diabetes Mellitus, Type 2Phase 1NCT01458210

A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants

A Phase 1 study testing Ortho-Cyclen 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 look at how the body processes oral contraceptive (OC), using Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the body. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Ortho-Cyclen and Dulaglutide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Oct 2011to Feb 2012
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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Are females of child-bearing potential, and who are overtly healthy as determined by medical history and physical examination
  • As it is possible that dulaglutide may cause the oral contraceptive (OC) tablet to be less effective than usual, participants will be required to use 2 additional highly effective methods of contraception from the screening appointment until 2 months after the poststudy follow-up appointment. Additional methods of contraception may include the following: a non-hormonal intrauterine device with spermicide; male or female condom with spermicide; contraceptive sponge with spermicide; diaphragm with spermicide; cervical cap with spermicide; sterile sexual partner; or abstinence (participants reporting abstinence who become sexually active while on the study must agree to use other additional methods of contraception). The pregnancy test result must be negative at screening and at each check-in
  • Have a body mass index (BMI) of between 18.5 and 30.0 kilogram-meter squared (kg/m^2), at screening
  • Have no clinically significant findings, as determined by the investigator, upon bimanual pelvic and breast examinations, at screening (provision of previous gynecological examination documentation may be accepted)
  • Have clinical laboratory test results within the 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
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and 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 Ortho-Cyclen, dulaglutide, or to related compounds or to any components of either formulation
  • Are persons who have previously completed or withdrawn from this study or any other study investigating dulaglutide within 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) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have an abnormal blood pressure (BP) (after at least 5 minutes sitting) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have a history or presence of respiratory, hepatic, renal, endocrine, 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
Show all 22Show fewer
  • Have a history or presence of cardiovascular disorder (including myocardial infarction, cerebrovascular accident, coronary artery disease, venous thromboembolism, arrhythmia [judged by the investigator to be clinically significant], or angina) within the last year, have symptoms or signs of congestive heart failure, or are expected to require coronary artery bypass surgery or angioplasty
  • 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 glucagon-like-peptide 1 (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 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 St John's Wort within 21 days of study drug administration or are unable/unwilling to adhere to the study drug restrictions
  • Have donated blood of more than 500 milliliter (mL) within the last month prior to admission of the lead-in phase
  • Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption for 48 hours prior to each admission to the clinical research unit (CRU) and while resident at the CRU (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)
  • Use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to admission into the lead-in phase
  • Have taken injectable contraceptives or have used hormonal implants within 12 months of enrollment to this study or topical controlled delivery contraceptives (patch) or hormonal intrauterine devices (such as, Mirena® device) within 3 months prior to enrollment of this study
  • The history or presence of any contraindications to the combined OC tablet including thrombosis and a history of thromboembolic disease, recurrent jaundice, acute or chronic liver disease, migraines, undiagnosed vaginal bleeding, significant hyperlipidemia, hepatic adenoma, and mammary, endometrial, or hepatic carcinoma or any other estrogen-dependent neoplasia (known or suspected)
  • In the opinion of the investigator or sponsor, are unsuitable for inclusion 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.

    Dallas, Texas

Other trials in United States

About this study

Official title: Effect of Dulaglutide (LY2189265) on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

The purpose of this study is to look at how the body processes oral contraceptive (OC), using Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the body. Information about any side effects that may occur will also be collected.

Being tested
Ortho-Cyclen, 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.

  • Ortho-CyclenDrug

    Administered orally

  • DulaglutideBiological

    Also called LY2189265

    Administered subcutaneously

Study groups in NCT01458210
Study groupRoleWhat they receive
Ortho-Cyclen (OC) Alone (Period 1); OC+Dulaglutide (Period 2)ExperimentalOrtho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course and the Period 2 sample was taken during the second 28-day course. Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2.
Receives: Drug: Ortho-Cyclen; Biological: Dulaglutide

What is being measured

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

  1. Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN)

    Measured: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose

  2. Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Norelgestromin (NGMN)

    Measured: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose

  3. Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Norelgestromin (NGMN)

    Measured: Day 21 Periods 1 and 2: Pre-dose and up to 24 hours post-dose

  4. Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Ethinyl Estradiol (EE)

    Measured: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose

  5. Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Ethinyl Estradiol (EE)

    Measured: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose

  6. Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Ethinyl Estradiol (EE)

    Measured: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose

Timeline

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

  1. First posted24 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01458210
Sponsor's protocol ID
11555
Other IDs
H9X-MC-GBCQ
Status last verified
Oct 2014
First submitted
19 Oct 2011
Last updated
8 Oct 2014
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ortho-Cyclen 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 8 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 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 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 Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN) (time frame: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose). The study lists 6 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 NCT01458210, 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 8 Oct 2014.

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