A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus
Completed · Phase 2 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT02091362
- Run by
- Eli Lilly and Company
- People needed
- 270
- Starts
- 2014-03-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2018-07-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Advanced Clinical Research Institute — Anaheim, California, United States
- National Research Institute — Los Angeles, California, United States
- Artemis Institute for Clinical Research — San Diego, California, United States
- Orange County Research Center — Tustin, California, United States
- University Clinical Investigators, Inc. — Tustin, California, United States
- Berma Research — Fort Lauderdale, Florida, United States
- East Coast Clinical Research — Jacksonville, Florida, United States
- Suncoast Research Group, LLC — Miami, Florida, United States
- Cedar-Crosse Research Center — Chicago, Illinois, United States
- Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
- L-Marc Research Center — Louisville, Kentucky, United States
- Maine Research Associates — Auburn, Maine, United States
- Alzohaili Medical Consultants — Dearborn, Michigan, United States
- Premier Research — Trenton, New Jersey, United States
- Manhattan Medical Research — New York, New York, United States
- 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, Czechia
- 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. — Krnov, Czechia
- 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, Czechia
- 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, Czechia
- 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, Mexico
- 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, Mexico
- 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, Mexico
- 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, Mexico
- 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, Poland
- 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, Poland
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