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Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes

A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine

NCT00355849•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder \[also known as AIR® Inhaled Insulin\]\[AIR® is a registered trademark of Alkermes,Inc.\] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. The present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily insulin glargine injections.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•type 2 diabetes mellitus
•one or more oral antihyperglycemic medications
•once-daily insulin glargine
•HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
•Non-smoker

Exclusion Criteria

•taking a TZD dose greater than what is indicated
•more than two episodes of severe hypoglycemia during the 6 months prior
•Have had a lower respiratory infection in the 3 months prior
•systemic glucocorticoid therapy
•clinical signs or symptoms of liver disease, acute or chronic hepatitis
•history of renal transplantation
•Have an active or untreated malignancy
•Require more than 150 U/day of insulin glargine

Locations (69)

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.

Fresno, California, United States

Pomona, California, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Peoria, Illinois, United States

New Albany, Indiana, United States

Topeka, Kansas, United States

Metairie, Louisiana, United States

Ann Arbor, Michigan, United States

Grand Rapids, Michigan, United States

Key Dates

Start Date

August 1, 2006

Primary Completion Date

June 1, 2008

Completion Date

June 1, 2008

Last Updated

September 16, 2019

Enrollment

555

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Human Insulin Inhalation Powder

DRUG

Insulin Glargine

DRUG

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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: September 16, 2019Data 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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Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes

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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Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

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