- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02091362
A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus
July 17, 2018 updated by: Eli Lilly and Company
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
270
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Holesov, Czechia, 76901
- 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.
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Krnov, Czechia, 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.
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Pardubice, Czechia, 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.
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Prague, Czechia, 14059
- 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.
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Coatzacoalcos, Mexico, 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.
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Guadalajara, Mexico, 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.
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Monterrey, Mexico, 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.
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Monterrey, Mexico, 64620
- 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.
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Gdansk, Poland, 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.
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Lodz, Poland, 90-242
- 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.
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Lublin, Poland, 20-538
- 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.
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Poznan, Poland, 61-853
- 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.
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Szczecin, Poland, 70-506
- 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.
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Manati, Puerto Rico, 00674
- Manati Center for Clinical Research Inc
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San Juan, Puerto Rico, 00921
- Consultorio Médico
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California
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Anaheim, California, United States, 92801
- Advanced Clinical Research Institute
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Los Angeles, California, United States, 90057
- National Research Institute
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San Diego, California, United States, 92103
- Artemis Institute for Clinical Research
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Tustin, California, United States, 92780
- University Clinical Investigators, Inc.
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Tustin, California, United States, 92780
- Orange County Research Center
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Berma Research
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Jacksonville, Florida, United States, 32204
- East Coast Clinical Research
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Miami, Florida, United States, 33135
- Suncoast Research Group, LLC
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Illinois
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Chicago, Illinois, United States, 60607
- Cedar-Crosse Research Center
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Indiana
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Indianapolis, Indiana, United States, 46260
- Midwest Institute for Clinical Research
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Kentucky
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Louisville, Kentucky, United States, 40213
- L-MARC Research Center
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Maine
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Auburn, Maine, United States, 04210
- Maine Research Associates
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Michigan
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Dearborn, Michigan, United States, 48124
- Alzohaili Medical Consultants
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New Jersey
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Trenton, New Jersey, United States, 08611
- Premier Research
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New York
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New York, New York, United States, 10016
- Manhattan Medical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods.
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Administered orally
Administered as background therapy.
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Experimental: LY2409021
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods.
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Administered orally
Administered as background therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure
Time Frame: Baseline, 6 Weeks
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Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).
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Baseline, 6 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure
Time Frame: Baseline, 6 Weeks
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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.
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Baseline, 6 Weeks
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Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate
Time Frame: Baseline, 6 Weeks
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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.
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Baseline, 6 Weeks
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Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures
Time Frame: Baseline, 6 Weeks
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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.
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Baseline, 6 Weeks
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Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)
Time Frame: Baseline, 6 Weeks
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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.
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Baseline, 6 Weeks
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Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, 6 Weeks
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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.
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Baseline, 6 Weeks
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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.
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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.
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Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose.
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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.
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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.
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Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
March 18, 2014
First Submitted That Met QC Criteria
March 18, 2014
First Posted (Estimate)
March 19, 2014
Study Record Updates
Last Update Posted (Actual)
July 19, 2018
Last Update Submitted That Met QC Criteria
July 17, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15261
- I1R-MC-GLDI (Other Identifier: Eli Lilly and Company)
- 2013-003834-33 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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