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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
History of Changes
  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:

U.S. FDA Resources

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
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 June 18, 2013