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COMPLETEDPHASE3

Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus

A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus

NCT00391209•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups: Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day. Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Type 2 diabetes mellitus for at least 6 months
•Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
•Patients who have been treated with the following regimen:
•One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones \[TZDs\]),
•AND
•have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,
•AND
•are candidates for insulin therapy, in the opinion of the investigator.

Exclusion Criteria

•Pregnancy
•Smoker
•History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
•Diagnosed with pneumonia in the 3 months prior to screening
•Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
•History of renal transplantation
•History of lung transplantation
•Active or untreated malignancy
•Treated with Incretin mimetics

Locations (42)

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.

Santa Ana, California, United States

Washington D.C., District of Columbia, United States

Hollywood, Florida, United States

New Port Richey, Florida, United States

South Miami, Florida, United States

Honolulu, Hawaii, United States

Idaho Falls, Idaho, United States

New Orleans, Louisiana, United States

Biddeford, Maine, United States

Minneapolis, Minnesota, United States

Key Dates

Start Date

October 1, 2006

Primary Completion Date

May 1, 2008

Completion Date

May 1, 2008

Last Updated

March 9, 2018

Enrollment

379

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder

DRUG

intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder

DRUG

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

NCT06959901

Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

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

NCT06574035

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 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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Compare Two Dosing Algorithms in Insulin-Naive Patients 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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