NCT02091362

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
5 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

July 19, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

10 months

First QC Date

March 18, 2014

Results QC Date

June 6, 2018

Last Update Submit

July 17, 2018

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure

    Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).

    Baseline, 6 Weeks

Secondary Outcomes (7)

  • Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure

    Baseline, 6 Weeks

  • Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate

    Baseline, 6 Weeks

  • Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures

    Baseline, 6 Weeks

  • Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)

    Baseline, 6 Weeks

  • Change From Baseline in Hemoglobin A1c (HbA1c)

    Baseline, 6 Weeks

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: PlaceboDrug: Metformin

LY2409021

EXPERIMENTAL

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

Drug: LY2409021Drug: Metformin

Interventions

LY2409021DRUG

Administered orally

LY2409021
PlaceboDRUG

Administered orally

Placebo
MetforminDRUG

Administered as background therapy.

LY2409021Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

University Clinical Investigators, Inc.

Tustin, California, 92780, United States

Location

Berma Research

Fort Lauderdale, Florida, 33316, United States

Location

East Coast Clinical Research

Jacksonville, Florida, 32204, United States

Location

Suncoast Research Group, LLC

Miami, Florida, 33135, United States

Location

Cedar-Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

L-Marc Research Center

Louisville, Kentucky, 40213, United States

Location

Maine Research Associates

Auburn, Maine, 04210, United States

Location

Alzohaili Medical Consultants

Dearborn, Michigan, 48124, United States

Location

Premier Research

Trenton, New Jersey, 08611, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

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, 76901, Czechia

Location

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, 79401, Czechia

Location

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, 53002, Czechia

Location

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, 14059, Czechia

Location

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, 96400, Mexico

Location

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, 44130, Mexico

Location

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, 64460, Mexico

Location

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, 64620, Mexico

Location

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, 80-546, Poland

Location

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, 90-242, Poland

Location

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, 20-538, Poland

Location

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, 61-853, Poland

Location

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, 70-506, Poland

Location

Manati Center for Clinical Research Inc

Manatí, 00674, Puerto Rico

Location

Consultorio Medico

San Juan, 00921, Puerto Rico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

adomeglivantMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 19, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 19, 2018

Results First Posted

July 19, 2018

Record last verified: 2018-07

Locations

CZ(4)US(15)PL(5)ME(4)PR(2)