A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus

NCT ID: NCT02091362

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-01-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Metformin

Intervention Type: DRUG

Administered as background therapy.

LY2409021

Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods.

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Metformin

Intervention Type: DRUG

Administered as background therapy.

Interventions

LY2409021

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Metformin

Administered as background therapy.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

Advanced Clinical Research Institute

Anaheim, California, United States

National Research Institute

Los Angeles, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Orange County Research Center

Tustin, California, United States

University Clinical Investigators, Inc.

Tustin, California, United States

Berma Research

Fort Lauderdale, Florida, United States

East Coast Clinical Research

Jacksonville, Florida, United States

Suncoast Research Group, LLC

Miami, Florida, United States

Cedar-Crosse Research Center

Chicago, Illinois, United States

Midwest Institute for Clinical Research

Indianapolis, Indiana, United States

L-Marc Research Center

Louisville, Kentucky, United States

Maine Research Associates

Auburn, Maine, United States

Alzohaili Medical Consultants

Dearborn, Michigan, United States

Premier Research

Trenton, New Jersey, United States

Manhattan Medical Research

New York, New York, 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.

Holešov, , Czechia

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.

Krnov, , Czechia

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.

Pardubice, , Czechia

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.

Prague, , Czechia

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.

Coatzacoalcos, , Mexico

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.

Guadalajara, , Mexico

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.

Monterrey, , Mexico

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.

Monterrey, , Mexico

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.

Gdansk, , Poland

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.

Lodz, , Poland

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.

Lublin, , Poland

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.

Poznan, , Poland

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

Manati Center for Clinical Research Inc

Manatí, , Puerto Rico

Consultorio Medico

San Juan, , Puerto Rico

Countries

United States; Czechia; Mexico; Poland; Puerto Rico

Other Identifiers

I1R-MC-GLDI

Identifier Type: OTHER

Identifier Source: secondary_id

2013-003834-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15261

Identifier Type: -

Identifier Source: org_study_id