Type 2 Diabetes MellitusPhase 2NCT02091362

A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus

A Phase 2 study testing LY2409021 and Metformin in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 30 sites in 5 countries.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: LY2409021 and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 270 participants
Where: 30 sitesin 5 countries
Study dates: Mar 2014to Jan 2015
Phase: Phase 2
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Have type 2 diabetes mellitus (according to the World Health Organization diagnostic criteria) and use diet and exercise alone or in combination with a stable dose of metformin ( >/=1000 mg/day [or <1000 mg, if documented intolerance to 1000 mg or higher dosages] immediate-release metformin or extended-release metformin for at least 2 months before screening).
Have glycated hemoglobin (HbA1c) values >/=6.5% and </=8.5%, as determined by the central laboratory at screening.
Have mean blood pressures >90/60 millimeters of mercury (mm Hg) and <140/90 mm Hg at screening.
If being treated for hypertension, are taking 3 or fewer antihypertensive medications and have been taking stable doses of the same medications for at least 1 month before screening.
Stable body weights (±5%) for >/=3 months before screening.
Body mass indexes >/=20 kilograms/meters squared (kg/m²) and <40 kg/m².

Show all 15Show fewer

In the investigator's opinion, are well motivated, capable, and willing to:
Reliably administer the oral study drug once daily;
Maintain a study diary;
Perform self-monitored blood glucose testing; and
Wear an ambulatory blood pressure monitoring device for at least 24 hours (on multiple occasions).
Are women not of child-bearing potential due to:
Surgical sterilization, hysterectomy, or bilateral oophorectomy (at least 6 weeks postsurgery) or tubal ligation (confirmed by medical history); or
Menopause. Women with an intact uterus are deemed menopausal if they have a cessation of menses for at least 1 year with follicle stimulating hormone >40 milli-international units per milliliter (mIU/mL), are not taking hormones or oral contraceptives within 1 year, and are otherwise healthy.
Males who are sexually active and/or have partners of child-bearing age must use reliable methods of birth control during the study and until 3 months after the last doses of study medication. These requirements do not apply if a participant or his partner has been surgically sterilized or is not between menarche and 1 year postmenopausal.

Who cannot join

Have severe gastrointestinal disease that may significantly affect gastric emptying or motility.
Previous histories or active diagnoses of pancreatitis.
Acute or chronic hepatitis, signs or symptoms of any other liver disease, or alanine aminotransferase (ALT) level greater than 2.5 times the upper limit of normal (ULN).
Elevated total bilirubin (greater than 2 times ULN), clinically suspicious signs or symptoms of cirrhosis or history of cirrhosis.
Mean resting pulse rate (PR) less than 60 beats per minute (bpm) or greater than 100 bpm.
Current diagnosis or personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia, or Von Hippel-Lindau disease.

Trial locations and contacts

30 sites in 5 countries.

Country

City, postcode or hospital

30 sites in 5 countries

United States15 sites

Advanced Clinical Research Institute
Anaheim, California, 92801
Maine Research Associates
Auburn, Maine, 04210
Cedar-Crosse Research Center
Chicago, Illinois, 60607
Alzohaili Medical Consultants
Dearborn, Michigan, 48124
Berma Research
Fort Lauderdale, Florida, 33316
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
East Coast Clinical Research
Jacksonville, Florida, 32204
National Research Institute
Los Angeles, California, 90057
L-Marc Research Center
Louisville, Kentucky, 40213
Suncoast Research Group, LLC
Miami, Florida, 33135
Manhattan Medical Research
New York, New York, 10016
Artemis Institute for Clinical Research
San Diego, California, 92103
Premier Research
Trenton, New Jersey, 08611
Orange County Research Center
Tustin, California, 92780
University Clinical Investigators, Inc.
Tustin, California, 92780

Other trials in United States

Poland5 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.
Gdansk, 80-546
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.
Lodz, 90-242
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Lublin, 20-538
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Poznan, 61-853
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Szczecin, 70-506

Other trials in Poland

Czechia4 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.
Holešov, 76901
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Krnov, 79401
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.
Pardubice, 53002
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.
Prague, 14059

Other trials in Czechia

Mexico4 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.
Coatzacoalcos, 96400
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.
Guadalajara, 44130
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.
Monterrey, 64460
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.
Monterrey, 64620

Other trials in Mexico

Puerto Rico2 sites

Manati Center for Clinical Research Inc
Manati, 00674
Consultorio Medico
San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: The Effect of LY2409021 on Blood Pressure and Pulse Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Subjects With Type 2 Diabetes Mellitus

The main purpose of the trial is to determine the effect of a study drug known as LY2409021 on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when compared to placebo. The study has two periods. Each participant will receive LY2409021 or placebo in each period. At least 4 weeks will pass between periods. The study will last about 23 weeks for each participant. Participants may remain on stable dose metformin, as prescribed by their personal physician.

Conditions: Type 2 Diabetes Mellitus
Being tested: LY2409021, Placebo, Metformin
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
MetforminDrug
Administered as background therapy.

Study groups in NCT02091362
Study group	Role	What they receive
Placebo	Placebo comparator	Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods. Receives: Drug: Placebo; Drug: Metformin
LY2409021	Experimental	Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods. Receives: Drug: LY2409021; Drug: Metformin

What is being measured

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

Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure
Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).
Measured: Baseline, 6 Weeks

Secondary outcomes (7)

Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure
Diastolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Measured: Baseline, 6 Weeks
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate
Pulse rate obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Measured: Baseline, 6 Weeks
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures
Pulse Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Measured: Baseline, 6 Weeks
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)
Mean Arterial Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Measured: Baseline, 6 Weeks
Change From Baseline in Hemoglobin A1c (HbA1c)
LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Measured: Baseline, 6 Weeks
Population Pharmacokinetics: Apparent Clearance of LY2409021
Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.
Measured: Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose.
Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021
Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.
Measured: Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose.

Timeline

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

Mar 2014Jan 2015

First posted19 Mar 2014 (estimated)
Study startMar 2014
Primary completionJan 2015
Study completionJan 2015

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 Type 2 Diabetes MellitusStudies 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 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02091362
Sponsor's protocol ID: 15261
Other IDs: I1R-MC-GLDI, 2013-003834-33
Status last verified: Jul 2018
First submitted: 18 Mar 2014
Last updated: 19 Jul 2018
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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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of LY2409021 on Blood Pressure and Pulse Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02091362
Acronym / sponsor ID: 15261
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 19 Mar 2014 (estimated)
Results: Posted 19 Jul 2018

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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo, Drug: MetforminSingle daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods.
LY2409021	Experimental	Drug: LY2409021, Drug: MetforminSingle daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Have type 2 diabetes mellitus (according to the World Health Organization diagnostic criteria) and use diet and exercise alone or in combination with a stable dose of metformin ( >/=1000 mg/day [or <1000 mg, if documented intolerance to 1000 mg or higher dosages] immediate-release metformin or extended-release metformin for at least 2 months before screening).
Have glycated hemoglobin (HbA1c) values >/=6.5% and </=8.5%, as determined by the central laboratory at screening.
Have mean blood pressures >90/60 millimeters of mercury (mm Hg) and <140/90 mm Hg at screening.
If being treated for hypertension, are taking 3 or fewer antihypertensive medications and have been taking stable doses of the same medications for at least 1 month before screening.
Stable body weights (±5%) for >/=3 months before screening.

Key exclusion criteria (6 listed)

Have severe gastrointestinal disease that may significantly affect gastric emptying or motility.
Previous histories or active diagnoses of pancreatitis.
Acute or chronic hepatitis, signs or symptoms of any other liver disease, or alanine aminotransferase (ALT) level greater than 2.5 times the upper limit of normal (ULN).
Elevated total bilirubin (greater than 2 times ULN), clinically suspicious signs or symptoms of cirrhosis or history of cirrhosis.
Mean resting pulse rate (PR) less than 60 beats per minute (bpm) or greater than 100 bpm.

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	LY2409021
PlaceboAdministered orally	Drug	Placebo
MetforminAdministered as background therapy.	Drug	LY2409021, Placebo

Primary outcome

Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure
Time frame: Baseline, 6 Weeks
Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).

7 secondary outcomes

Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure
Time frame: Baseline, 6 Weeks
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate
Time frame: Baseline, 6 Weeks
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures
Time frame: Baseline, 6 Weeks
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)
Time frame: Baseline, 6 Weeks
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 6 Weeks
Population Pharmacokinetics: Apparent Clearance of LY2409021
Time frame: Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose.
Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021
Time frame: Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose.

Results and safety

Results posted to the registry on 19 Jul 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
LY2409021/Placebo	133	128
Placebo/LY2409021	137	133

Primary outcome: Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure

Time frame: Baseline, 6 Weeks. Least squares mean (95% Confidence Interval). Unit: mmHg

Measure	LY2409021 20 mg n = 241	Placebo n = 239
Value	2.79 (1.62 to 3.95)	0.53 (-0.70 to 1.76)

LY2409021 20 mg vs Placebo: LS Mean Difference: 2.26 (95% CI 1.11 to 3.40), p <.001, Mixed Models Analysis

Population analysed: Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2409021 20 mg	4 of 258 (1.6%)	49 of 258 (19%)	Not reported
Placebo	2 of 256 (0.8%)	32 of 256 (12.5%)	Not reported
Wash-out	2 of 249 (0.8%)	25 of 249 (10%)	Not reported
Follow-up	4 of 253 (1.6%)	30 of 253 (11.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
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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

30 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2409021 and Metformin in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 30 sites in 5 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 15 inclusion and 6 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Poland, Czechia, Mexico, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Jul 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?

Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure (time frame: Baseline, 6 Weeks). 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 NCT02091362.

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 19 Jul 2018.