Diabetes Mellitus, Type 2Phase 1NCT01460368

A Study on the Effects of LY2409021 on the Electrical Impulses of the Heart

A Phase 1 study testing LY2409021 and Moxifloxacin 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

Part A: The purpose of Part A of the study is to look at the electrocardiogram (ECG) effects due to blood sugar changes after a meal compared to when LY2409021 is also given with a meal. 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?: LY2409021 and Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 67 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Mar 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 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
female participants: women not of child-bearing potential due to surgical sterilization (hysterectomy alone or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history, or menopause Women with an intact uterus are deemed postmenopausal if they are >=45 years old, have not taken hormones or oral contraceptives within the last year, had cessation of menses for at least 1 year, or have had 6 to 12 months of amenorrhea with follicle-stimulating hormone levels consistent with postmenopausal state
have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m^2), inclusive, at screening
have a fasting blood glucose between 54 to 110 milligrams per deciliter (mg/dL) (3.0 to 6.1 millimoles per liter [mmol/L])
have a clinically normal screening electrocardiogram (ECG) with a measurable QT interval as judged by central reader, which allows accurate measurements of QT interval
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

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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
have normal blood pressure and pulse rate (supine) at screening, or with minor deviations judged to be acceptable by the investigator
have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
serum magnesium and potassium equal to or above the lower limit of normal

Who cannot join

are currently enrolled in or have completed or discontinued within the last 30 days (from screening) 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 LY2409021, related compounds or any components of the formulations, or to moxifloxacin
are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2409021
personal or family history of long QT syndrome
family history of sudden unexplained death or cardiac death in a family member under 60 years of age
personal history of unexplained syncope within the last year

Show all 17Show fewer

have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, 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
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
intend to use over-the-counter (including mineral supplements and herbal medicine) or prescription medication within 7 days prior to dosing
have donated blood of more than 500 milliliters (mL) within the last month
have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) (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), or are unwilling to comply with alcohol restrictions during the study (that is, refrain from alcohol consumption from 24 hours prior to dosing until the completion of each treatment period and to consume no more than 2 units of alcohol per day between treatment periods)
are participants who smoke more than 10 cigarettes per day and/or are unable to abide by the study restrictions for smoking/tobacco use (that is, refrain from smoking for approximately 2 hours prior to each ECG timepoint or for a total of approximately 12 hours)
are participants who are unable to abide by the study restrictions for caffeine/xanthine use (that is, refrain from consuming caffeine/xanthine containing drinks and foods [such as coffee, tea, cola, and chocolate] on days on which ECGs are performed, and maintain consistent consumption habits on all other days of 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: A Placebo- and Positive-Controlled Study of the Electrophysiological Effects of a Supratherapeutic Dose of LY2409021 in Healthy Subjects

Part A: The purpose of Part A of the study is to look at the electrocardiogram (ECG) effects due to blood sugar changes after a meal compared to when LY2409021 is also given with a meal.

Part B: The purpose of Part B is to evaluate the effect of LY2409021, when given at a dose level much higher than what would normally be given, on the electrical activity of the heart as measured by ECG in relation to placebo and moxifloxacin.

Read the detailed description

This is a 2 part study. Part A is a single-dose study to compare the effects of a meal on glucose, insulin and QT in healthy participants with and without LY2409021. Part B of this study is a randomized, 3-period, crossover design, in which participants and investigators are blinded to placebo and LY2409021, and will assess the electrophysiological effects of a single supratherapeutic dose of LY2409021 compared to a positive control (moxifloxacin) and placebo.

Conditions: Diabetes Mellitus, Type 2
Being tested: LY2409021, Placebo, Moxifloxacin
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.

LY2409021Drug
Administered orally
PlaceboDrug
Administered orally
MoxifloxacinDrug
Administered orally

Study groups in NCT01460368
Study group	Role	What they receive
Part A: LY2409021	Experimental	Participants will receive 2 standard meals; one alone without LY2409021, and one along with a single dose of 300 milligrams (mg) LY2409021 administered orally. Participants enrolled in Part A will not be allowed to participate in Part B. Receives: Drug: LY2409021
Part B: LY2409021	Experimental	300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. Receives: Drug: LY2409021
Part B: Placebo	Placebo comparator	Administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. Receives: Drug: Placebo
Part B: Moxifloxacin	Active comparator	400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. Receives: Drug: Moxifloxacin

What is being measured

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

Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (LY2409021)
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.
Measured: Baseline, 2, 4, 6, 8, 12, and 24 hours

Secondary outcomes (1)

Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (Moxifloxacin)
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.
Measured: Baseline, 2 and 4 hours

Timeline

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

Oct 2011Mar 2012

First posted26 Oct 2011 (estimated)
Study startOct 2011
Primary completionMar 2012
Study completionMar 2012

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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01460368
Sponsor's protocol ID: 14149
Other IDs: I1R-FW-GLBP
Status last verified: Dec 2018
First submitted: 7 Oct 2011
Last updated: 7 Jan 2019
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo- and Positive-Controlled Study of the Electrophysiological Effects of a Supratherapeutic Dose of LY2409021 in Healthy Subjects
ClinicalTrials.gov ID: NCT01460368
Acronym / sponsor ID: 14149
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 26 Oct 2011 (estimated)
Results: Posted 18 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Part A: The purpose of Part A of the study is to look at the electrocardiogram (ECG) effects due to blood sugar changes after a meal compared to when LY2409021 is also given with a meal.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Part A: LY2409021	Experimental	Drug: LY2409021Participants will receive 2 standard meals; one alone without LY2409021, and one along with a single dose of 300 milligrams (mg) LY2409021 administered orally. Participants enrolled in Part A will not be allowed to participate in Part B.
Part B: LY2409021	Experimental	Drug: LY2409021300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length.
Part B: Placebo	Placebo comparator	Drug: PlaceboAdministered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length.
Part B: Moxifloxacin	Active comparator	Drug: Moxifloxacin400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length.

Who may qualify

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

Key inclusion criteria (11 listed)

are overtly healthy males or females, as determined by medical history and physical examination
female participants: women not of child-bearing potential due to surgical sterilization (hysterectomy alone or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy or tubal ligation) confirmed by medical history, or menopause Women with an intact uterus are deemed postmenopausal if they are >=45 years old, have not taken hormones or oral contraceptives within the last year, had cessation of menses for at least 1 year, or have had 6 to 12 months of amenorrhea with follicle-stimulating hormone levels consistent with postmenopausal state
have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m^2), inclusive, at screening
have a fasting blood glucose between 54 to 110 milligrams per deciliter (mg/dL) (3.0 to 6.1 millimoles per liter [mmol/L])
have a clinically normal screening electrocardiogram (ECG) with a measurable QT interval as judged by central reader, which allows accurate measurements of QT interval

Key exclusion criteria (17 listed)

are currently enrolled in or have completed or discontinued within the last 30 days (from screening) 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 LY2409021, related compounds or any components of the formulations, or to moxifloxacin
are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2409021
personal or family history of long QT syndrome
family history of sudden unexplained death or cardiac death in a family member under 60 years of age

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
LY2409021Administered orally	Drug	Part A: LY2409021, Part B: LY2409021
PlaceboAdministered orally	Drug	Part B: Placebo
MoxifloxacinAdministered orally	Drug	Part B: Moxifloxacin

Primary outcome

Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (LY2409021)
Time frame: Baseline, 2, 4, 6, 8, 12, and 24 hours
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.

1 secondary outcome

Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (Moxifloxacin)
Time frame: Baseline, 2 and 4 hours

Results and safety

Results posted to the registry on 18 Oct 2018, 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: LY2409021	7	7
Part B: LY2409021, Placebo, Moxifloxacin	0	0
Part B: Moxifloxacin, LY2409021, Placebo	0	0
Part B: Placebo, Moxifloxacin, LY2409021	0	0
Part B: Moxifloxacin, Placebo, LY2409021	0	0
Part B: Placebo, LY2409021, Moxifloxacin	0	0
Part B: LY2409021, Moxifloxacin, Placebo	0	0

Primary outcome: Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (LY2409021)

Time frame: Baseline, 2, 4, 6, 8, 12, and 24 hours. Least squares mean (90% Confidence Interval). Unit: milliseconds

Measure	Part B: LY2409021 n = 58	Part B: Placebo n = 56
2 hours postdose	-14.72 (-16.44 to -13.00)	-15.35 (-17.10 to -13.59)
4 hours postdose	-5.43 (-7.15 to -3.72)	-9.12 (-10.89 to -7.35)
6 hours postdose	6.13 (4.40 to 7.85)	-3.01 (-4.77 to -1.26)
8 hours postdose	7.80 (6.09 to 9.51)	-1.29 (-3.02 to 0.45)
12 hours postdose	-13.45 (-15.15 to -11.74)	-13.30 (-15.05 to -11.55)
24 hours postdose	-1.32 (-3.04 to 0.40)	-4.95 (-6.70 to -3.20)

Part B: LY2409021 vs Part B: Placebo: Least Squares Mean Difference: 0.63 (90% CI -1.38 to 2.63)
Part B: LY2409021 vs Part B: Placebo: Least Squares Means Difference: 3.69 (90% CI 1.67 to 5.71)
Part B: LY2409021 vs Part B: Placebo: Least Squares Means Difference: 9.14 (90% CI 7.12 to 11.16)

Population analysed: Participants who received at least 1 dose of LY2409021 or Placebo with evaluable Fridericia Correction Formula (QTcF) data.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: LY2409021	0 of 7 (0%)	1 of 7 (14.3%)	Not reported
Part B: Placebo	0 of 57 (0%)	12 of 57 (21.1%)	Not reported
Part B: Moxifloxacin	0 of 58 (0%)	11 of 58 (19%)	Not reported
Part B: LY2409021	0 of 59 (0%)	9 of 59 (15.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
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 LY2409021 and Moxifloxacin 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 11 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 Jan 2019. 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. 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 18 Oct 2018). 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?

Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (LY2409021) (time frame: Baseline, 2, 4, 6, 8, 12, and 24 hours). 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 NCT01460368.

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 Jan 2019.