a study of ly2409021 on blood pressure and pulse rate in participants with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: 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.


Eligibility criteria:
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.