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

Phase 2

Completed

• Registration Number: CTRI/2010/091/001444
• Lead Sponsor: Eli Lilly

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 683

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
-HbA1c value greater than or equal to 7% and less than or equal to 9.5% at screening
-Mean blood pressure > 90/60 mmHg and < 140/90 mmHg at screening
-If treated for hypertension, are taking 3 or less medications and have been taking these medications for at least 1 month prior to screening
-Stable weight for 3 months prior to screening
-BMI (body mass index) greater than or equal to 23 kg/m2
-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 patients 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 bpm or > 100 bpm at screening
-Work rotating shifts or work during the hours of 2200 to 0700
-Chronic insulin therapy
-Use of a GLP-1 receptor agonists within 3 months prior to screening, or a dipeptidylpeptidase-IV (DPP-IV) inhibitor within 2 weeks prior to screening
-Nondominant arm circumference > 42 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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline to 16 weeks in mean 24-hour systolic blood pressure (SBP)Timepoint: baseline, 16 weeks