Status:
COMPLETED
A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 diabe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
755 Patients enrolled
Trial Details
Trial ID
NCT01149421
Start Date
June 1 2010
End Date
January 1 2012
Last Update
February 2 2015
Active Locations (76)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix, Arizona, United States, 85013
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Anaheim, California, United States, 92801
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Greenbrae, California, United States, 94904
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lancaster, California, United States, 93534