Who is sponsoring NCT00437112?

NCT00437112 is sponsored by Eli Lilly and Company.

What condition does NCT00437112 study?

NCT00437112 studies Diabetes Mellitus, Type 2.

What drugs are being tested in NCT00437112?

Interventions: Human Insulin Inhalation Powder, Insulin Glargine.

What is the status of NCT00437112?

NCT00437112 is currently COMPLETED.

Last reviewed 2018-03-07 · How we verify

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 Phase 3 COMPLETED

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.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	COMPLETED
Enrolment	142
Start date	2007-02
Completion	2008-05

Conditions

Diabetes Mellitus, Type 2

Interventions

Human Insulin Inhalation Powder
Insulin Glargine

Primary outcomes

Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint. — 56 weeks

Countries

United States, Brazil, India, Puerto Rico, Spain