A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effects of 2 doses of LY2189265 on blood pressure and heart rate using 24-hour ambulatory blood pressure monitoring (ABPM), in participants with type 2 diabetes mellitus treated with oral antihyperglycemic medications (OAMs).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dulaglutide

Criteria

Inclusion Criteria:

• Type 2 diabetes taking 1 or more oral diabetes medications and have taken these medications for at least 1 month prior to screening

• Glycosylated hemoglobin (HbA1c) value ≥7% and ≤9.5% at screening

• Mean blood pressure >90/60 millimeters of mercury (mmHg) and <140/90 mmHg at screening

• If treated for hypertension, are taking 3 or less antihypertensive medications and have been taking these medications for at least 1 month prior to screening

• Stable weight for 3 months prior to screening

• Body mass index (BMI) greater than or equal to 23 kilogram-meter squared (kg/m^2)

• Willing to wear an ambulatory blood pressure monitoring device for at least 24 hours on multiple occasions

• Women of childbearing potential must test negative for pregnancy and be willing to use a reliable method of birth control

• Male participants must use a reliable method of birth control

Exclusion Criteria:

• Myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure Class III or IV at screening

• Ongoing or history of frequent intermittent tachyarrhythmia

• Resting heart rate <60 beats per minute (bpm) or >100 bpm at screening

• Work rotating shifts or work during the hours of 2200 to 0700

• Chronic insulin therapy

• Use of a glucagon-like peptide 1 (GLP-1) receptor agonist within 3 months prior to screening, or a dipeptidylpeptidase-IV (DPP-IV) inhibitor within 2 weeks prior to screening

• Nondominant arm circumference >42 centimeter (cm)

• Use of drugs to promote weight loss

• Chronic use of systemic steroids

• Gastric emptying abnormality or bariatric surgery

• Hepatitis, other liver disease, or alanine transaminase (ALT) >3 times the upper limit of normal

• Acute or chronic pancreatitis

• Severe renal impairment

• Active autoimmune disease or uncontrolled endocrine abnormality

• Self or family history of thyroid cancer, medullary C-cell hyperplasia, or type 2A or 2B multiple endocrine neoplasia

• Calcitonin value greater than or equal to 20 picograms per milliliter (pg/ml) at screening

• Transplanted organ except corneal transplants

• Active or untreated cancer or in remission <5 years, except skin, in situ cervical, or prostate cancer

• Sickle-cell disease, hemolytic anemia, or another hematological condition that may interfere with HbA1c testing