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COMPLETEDPHASE1

A Study of LY2405319 in Participants With Type 2 Diabetes

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2405319 With 28 Days of Subcutaneous Injections in Patients With Type 2 Diabetes Mellitus

NCT01869959•Eli Lilly and Company

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Summary

The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It was given as a daily injection under the skin to participants with type 2 diabetes mellitus (T2DM) for 28 days. This study determined how long the drug stays in the body and how it affects blood sugar levels. After screening, the study lasted about 2 months for each participant. Participants continued their prestudy regimen of diet and exercise alone or in combination with metformin.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have a diagnosis of T2DM.
•Are on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days) regimen.
•Have a glycosylated hemoglobin A1c (HbA1c) value of 7.0% to 10.0%, inclusive, or are on metformin and an additional oral antidiabetic medication (OAM) with an HbA1c value of 6.5% to 9.5%, inclusive.
•Participants on another OAM in addition to metformin therapy may be randomized if removed from treatment of the other OAM ≥14 days prior to study drug administration and fasting blood glucose is ≥145 mg per deciliter (mg/dL) and ≤270 mg/dL.
•Are females not of child-bearing potential due to surgical sterilization or are postmenopausal.
•Have a body mass index (BMI) ≥25 and ≤40.
•Have clinical laboratory test results within normal reference range for the population.

Exclusion Criteria

•Use insulin, thiazolidinediones (TZDs), dipeptidyl peptidase (DPP) IV inhibitors, or exenatide during the 3 months prior to screening.
•Have had more than 1 episode of severe hypoglycemia requiring assistance of another person to administer a resuscitative action within 6 months prior to entry into the study or are currently diagnosed with having hypoglycemia unawareness.
•Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
•Have any abnormality of the electrocardiogram (ECG) that will, in the opinion of the investigator, impair the ability to measure the QT (a corrected QC \[QTc\] \[Bazett's correction\] interval \>450 milliseconds \[msec\] for men and \>470 msec for women or a PR interval \>220 msec are specifically excluded) or have conduction abnormalities that may confound the QTc analysis.
•Have a personal or family history of long QT syndrome, family history of sudden death, personal history of unexplained syncope within the last year; or use prescription or over-the-counter medications known to prolong the QT or QTc interval.
•Have diastolic blood pressure (DBP) ≥95 millimeters of mercury (mm Hg) and/or systolic blood pressure (SBP) ≥160 mm Hg.
•Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for \<5 years.
•Have a history of a transplanted organ.
•Evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator, at screening.
•Have a history of human immunodeficiency virus (HIV).
+9 more criteria

Locations (7)

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.

Cypress, California, United States

Tustin, California, United States

DeLand, Florida, United States

Miramar, Florida, United States

Cincinnati, Ohio, United States

Portland, Oregon, United States

San Antonio, Texas, United States

Key Dates

Start Date

April 1, 2009

Primary Completion Date

June 1, 2009

Completion Date

December 1, 2009

Last Updated

March 20, 2017

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2405319

DRUG

Placebo

DRUG

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Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

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Diabetes Mellitus, Type 2Depressive Symptoms+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY2405319 in Participants With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

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