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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:7/21/2018
Start Date:March 2014
End Date:January 2015

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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.


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 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.
We found this trial at
16
sites
Anaheim, California 92801
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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2128 W Flagler St # 201
Miami, Florida 33144
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Auburn, Maine 04210
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Chicago, Illinois 60607
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Chicago, IL
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Dearborn, Michigan 48124
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Fort Lauderdale, Florida 33316
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Holesov,
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Jacksonville, Florida 32204
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Louisville, Kentucky 40213
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Louisville, KY
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New York, New York 10016
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New York, NY
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San Diego, California 92123
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Trenton, New Jersey 08611
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Trenton, NJ
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Tustin, California
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Tustin, California 92780
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Tustin, CA
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