A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02091362
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Metformin Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods. LY2409021 Metformin Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods. Placebo Placebo Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods. LY2409021 LY2409021 Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods.
- Primary Outcome Measures
Name Time Method Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure Baseline, 6 Weeks Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, 6 Weeks LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Population Pharmacokinetics: Apparent Clearance of LY2409021 Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose. Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.
Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021 Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose. Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.
Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure Baseline, 6 Weeks Diastolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate Baseline, 6 Weeks Pulse rate obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures Baseline, 6 Weeks Pulse Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP) Baseline, 6 Weeks Mean Arterial Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Trial Locations
- Locations (18)
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
East Coast Clinical Research
🇺🇸Jacksonville, Florida, United States
Berma Research
🇺🇸Fort Lauderdale, Florida, United States
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
L-Marc Research Center
🇺🇸Louisville, Kentucky, United States
Alzohaili Medical Consultants
🇺🇸Dearborn, Michigan, United States
Manhattan Medical Research
🇺🇸New York, New York, United States
Manati Center for Clinical Research Inc
🇵🇷Manati, Puerto Rico
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
Premier Research
🇺🇸Trenton, New Jersey, United States
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.
🇵🇱Szczecin, Poland
Consultorio Medico
🇵🇷San Juan, Puerto Rico
Maine Research Associates
🇺🇸Auburn, Maine, United States