Clinical trial NCT02091362: A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus
Official title: The Effect of LY2409021 on Blood Pressure and Pulse Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-03-19
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of the trial is to determine the effect of a study drug known as LY2409021 on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when compared to placebo. The study has two periods. Each participant will receive LY2409021 or placebo in each period. At least 4 weeks will pass between periods. The study will last about 23 weeks for each participant. Participants may remain on stable dose metformin, as prescribed by their personal physician.


Eligibility criteria: Inclusion Criteria:

* Have type 2 diabetes mellitus (according to the World Health Organization diagnostic criteria) and use diet and exercise alone or in combination with a stable dose of metformin ( \>/=1000 mg/day \[or \<1000 mg, if documented intolerance to 1000 mg or higher dosages\] immediate-release metformin or extended-release metformin for at least 2 months before screening).
* Have glycated hemoglobin (HbA1c) values \>/=6.5% and \</=8.5%, as determined by the central laboratory at screening.
* Have mean blood pressures \>90/60 millimeters of mercury (mm Hg) and \<140/90 mm Hg at screening.
* If being treated for hypertension, are taking 3 or fewer antihypertensive medications and have been taking stable doses of the same medications for at least 1 month before screening.
* Stable body weights (±5%) for \>/=3 months before screening.
* Body mass indexes \>/=20 kilograms/meters squared (kg/m²) and \<40 kg/m².
* In the investigator's opinion, are well motivated, capable, and willing to:

  * Reliably administer the oral study drug once daily;
  * Maintain a study diary;
  * Perform self-monitored blood glucose testing; and
  * Wear an ambulatory blood pressure monitoring device for at least 24 hours (on multiple occasions).
* Are women not of child-bearing potential due to:

  * Surgical sterilization, hysterectomy, or bilateral oophorectomy (at least 6 weeks postsurgery) or tubal ligation (confirmed by medical history); or
  * Menopause. Women with an intact uterus are deemed menopausal if they have a cessation of menses for at least 1 year with follicle stimulating hormone \>40 milli-international units per milliliter (mIU/mL), are not taking hormones or oral contraceptives within 1 year, and are otherwise healthy.
* Males who are sexually active and/or have partners of child-bearing age must use reliable methods of birth control during the study and until 3 months after the last doses of study medication. These requirements do not apply if a participant or his partner has been surgically sterilized or is not between menarche and 1 year postmenopausal.

Exclusion Criteria:

* Have severe gastrointestinal disease that may significantly affect gastric emptying or motility.
* Previous histories or active diagnoses of pancreatitis.
* Acute or chronic hepatitis, signs or symptoms of any other liver disease, or alanine aminotransferase (ALT) level greater than 2.5 times the upper limit of normal (ULN).
* Elevated total bilirubin (greater than 2 times ULN), clinically suspicious signs or symptoms of cirrhosis or history of cirrhosis.
* Mean resting pulse rate (PR) less than 60 beats per minute (bpm) or greater than 100 bpm.
* Current diagnosis or personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia, or Von Hippel-Lindau disease.

Primary outcomes:
measure: Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure
timeFrame: Baseline, 6 Weeks
Secondary outcomes:
measure: Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure
timeFrame: Baseline, 6 Weeks
measure: Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate
timeFrame: Baseline, 6 Weeks
measure: Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures
timeFrame: Baseline, 6 Weeks
measure: Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)
timeFrame: Baseline, 6 Weeks
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 6 Weeks
measure: Population Pharmacokinetics: Apparent Clearance of LY2409021
timeFrame: Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose.
measure: Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021
timeFrame: Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose.
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Fort Lauderdale
country: United States
facility: Berma Research
state: Florida
city: Jacksonville
country: United States
facility: East Coast Clinical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Louisville
country: United States
facility: L-Marc Research Center
state: Kentucky
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Dearborn
country: United States
facility: Alzohaili Medical Consultants
state: Michigan
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Holesov
country: Czechia
facility: 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.
city: Krnov
country: Czechia
facility: 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.
city: Pardubice
country: Czechia
facility: 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.
city: Prague
country: Czechia
facility: 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.
city: Coatzacoalcos
country: Mexico
facility: 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.
city: Guadalajara
country: Mexico
facility: 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.
city: Monterrey
country: Mexico
facility: 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.
city: Monterrey
country: Mexico
facility: 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.
city: Gdansk
country: Poland
facility: 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.
city: Lodz
country: Poland
facility: 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.
city: Lublin
country: Poland
facility: 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.
city: Poznan
country: Poland
facility: 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.
city: Szczecin
country: Poland
facility: 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.
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research Inc
city: San Juan
country: Puerto Rico
facility: Consultorio Medico
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: