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A Study in Participants With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

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A Study in Participants With Type 2 Diabetes Mellitus

The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin With Insulin Lispro: a Double-Blind, Randomized, 26-week Study - The IMAGINE 4 Study

NCT01468987•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is: * To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. * To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment. * To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment. * To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have type 2 diabetes mellitus based on the World Health Organization (WHO) classification
•Had diabetes ≥1 year
•Have a hemoglobin A1c (HbA1c) value ≥7.0% and \<12.0% at screening
•Have a body mass index (BMI) ≤45.0 kilograms per square meter (kg/m\^2)
•Participants on any glucose lowering regimen that contains at least 1 daily insulin injection
•This inclusion criterion applies ONLY to women of childbearing potential
•* Are not breastfeeding
•* Test negative for pregnancy at screening and randomization
•* Do not intend to become pregnant during the study
•* Have practiced a reliable method of birth control for at least 6 weeks prior to screening
+5 more criteria

Exclusion Criteria

•Continuous subcutaneous insulin infusion therapy prior to screening
•Are using twice daily insulin glargine prior to screening
•Excessive insulin resistance defined as having received a daily dose of insulin ≥2.0 units per kilogram (units/kg) at the time of pre-randomization
•Glucagon-like peptide-1 (GLP-1) receptor agonist (eg, exenatide, exenatide once weekly, or liraglutide), thiazolidinedione (rosiglitazone, pioglitazone), or pramlintide, used concurrently or within 90 days prior to screening
•Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening; or, are using lipid-lowering medication at a dose that has not been stable for ≥90 days prior to screening
•Have fasting hypertriglyceridemia (defined as \>4.5 millimoles per liter \[mmol/L\], \>400 milligrams per deciliter \[mg/dL\]) at screening
•Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications for weight loss
•Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to entry into the study
•Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening
•Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening
+13 more criteria

Locations (156)

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.

Mobile, Alabama, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Anaheim, California, United States

Chino, California, United States

Concord, California, United States

Fresno, California, United States

La Mesa, California, United States

Lancaster, California, United States

Mission Hills, California, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

August 1, 2013

Completion Date

August 1, 2013

Last Updated

April 17, 2018

Enrollment

1,369

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2605541

DRUG

Insulin Glargine

DRUG

Insulin Lispro

DRUG

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

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Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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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: April 17, 2018Data 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 in Participants With Type 2 Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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