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 |
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.
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 =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.
We found this trial at
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