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

COMPLETEDPHASE3

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

A Phase 3, Open-Label, Crossover Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared With Once-Daily Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes Mellitus on Oral Agents

NCT00437112•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

A study to compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type 2 diabetes who are currently taking oral medications and have not previously taken insulin. Change in HbA1c levels will be reviewed to determine superiority or inferiority of the AIR Inhaled Insulin regimen.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Type 2 Diabetes Mellitus
•Insulin naive
•One or more oral antihyperglycemic medications
•HbA1c greater than or equal to 8.0% and less than or equal to 10.5%
•Non-smoker

Exclusion Criteria

•Taking a TZD dose greater than what is indicated
•Have not taken insulin within 6 months of entry into study
•Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
•Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
•Have had pneumonia in the 3 months prior to study entry
•Systemic glucocorticoid therapy
•Clinical signs or symptoms of liver disease, acute or chronic hepatitis
•History of renal transplantation
•Have an active or untreated malignancy
•Have a current diagnosis or past history of clinically relevant pulmonary disease
+1 more criteria

Locations (19)

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.

Greenbrae, California, United States

Topeka, Kansas, United States

Toms River, New Jersey, United States

Albuquerque, New Mexico, United States

New Braunfels, Texas, United States

San Antonio, Texas, United States

Porto Alegre, Brazil

São Paulo, Brazil

Indore, India

Kochi, India

Key Dates

Start Date

February 1, 2007

Primary Completion Date

May 1, 2008

Completion Date

May 1, 2008

Last Updated

March 9, 2018

Enrollment

142

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Human Insulin Inhalation Powder

DRUG

Insulin Glargine

DRUG

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

NCT06959901

Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

View study

RECRUITINGNA

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

NCT06574035

Diabetes Mellitus, Type 2Depressive Symptoms+1 more

View study

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 9, 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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Evaluate the Efficacy and Safety of Insulin Compared to Glargine 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

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

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

Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)