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

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Human Insulin Inhalation Powder; Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00355849

H7U-MC-IDBA (Other Identifier)

9632

Details and patient eligibility

About

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.

Enrollment: 555 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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555 participants in 3 patient groups

1

Experimental group

Description:

Intensified Glargine

Treatment:

Drug: Insulin Glargine

2

Experimental group

Description:

HIIP

Treatment:

Drug: Human Insulin Inhalation Powder

3

Experimental group

Description:

Intensified Glargine plus HIIP

Treatment:

Drug: Human Insulin Inhalation Powder

Drug: Insulin Glargine