A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2189265; Placebo
Intervention description: Administered as a subcutaneous injection once weekly for 26 weeks; Administered as a subcutaneous injection once weekly for 26 weeks
Intervention MeSH terms: Dulaglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 755.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes; Diabetes; Ambulatory Blood Pressure Monitoring; ABPM; Blood Pressure; Heart Rate

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).
    

Eligibility 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