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

Lilly

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: LY2189265

Study type: Interventional

Funder types: Industry

Identifiers

NCT01149421

H9X-MC-GBDN (Other Identifier)

CTRI/2010/091/001444 (Registry Identifier)

13631 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 755 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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755 participants in 3 patient groups, including a placebo group

1.5 milligram (mg) LY2189265

Experimental group

Description:

LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW)

Treatment:

Drug: LY2189265

0.75 milligram (mg) LY2189265

Experimental group

Description:

LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW)

Treatment:

Drug: LY2189265

Placebo

Placebo Comparator group

Description:

Placebo: subcutaneous (SC), once weekly (QW)

Treatment:

Drug: Placebo