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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01149421
First received: June 15, 2010
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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 patients with type 2 diabetes mellitus treated with oral antihyperglycemic medications(OAMs).


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: LY2189265
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 16 weeks in mean 24-hour systolic blood pressure (SBP) [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline to 16 and 26 weeks in mean daytime and nighttime SBP [ Time Frame: Baseline, 16 and 26 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 16 and 26 weeks in mean 24-hour, daytime, and nighttime diastolic blood pressure (DBP) [ Time Frame: Baseline, 16 and 26 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 16 and 26 weeks in mean 24-hour, daytime, and nighttime mean arterial pressure (MAP) [ Time Frame: Baseline, 16 and 26 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 weeks in mean 24-hour SBP [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 16 and 26 weeks in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 16 and 26 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 16 and 26 weeks in fasting blood glucose (FBG) [ Time Frame: Baseline, 16 and 26 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of hypoglycemic episodes [ Time Frame: Baseline, 16 and 26 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 16 and 26 weeks in body weight [ Time Frame: Baseline, 16 and 26 weeks ] [ Designated as safety issue: Yes ]
  • Anti-LY2189265 antibodies [ Time Frame: Baseline through 26 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 16 and 26 weeks in mean 24-hour, daytime, and nighttime heart rate (HR) [ Time Frame: Baseline, 16 and 26 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 16 and 26 weeks in mean 24-hour, daytime, and nighttime pulse pressure [ Time Frame: Baseline, 16 and 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 693
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Administered as a subcutaneous injection once weekly for 26 weeks
Experimental: 0.75 mg LY2189265 Drug: LY2189265
Administered as a subcutaneous injection once weekly for 26 weeks
Other Name: Dulaglutide
Experimental: 1.5 mg LY2189265 Drug: LY2189265
Administered as a subcutaneous injection once weekly for 26 weeks
Other Name: Dulaglutide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149421

  Show 76 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01149421     History of Changes
Other Study ID Numbers: 13631, H9X-MC-GBDN, CTRI/2010/091/001444
Study First Received: June 15, 2010
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
India: Ministry of Health

Keywords provided by Eli Lilly and Company:
Type 2 Diabetes
Diabetes
Ambulatory Blood Pressure Monitoring
ABPM
Blood Pressure
Heart Rate

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014