Evaluate the Efficacy and Safety of Insulin Compared to Glargine 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

NCT00437112

9631

H7U-MC-IDAZ

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• Taking or have taken exenatide during the 6 weeks prior to study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

1

Experimental group

Description:

4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation 8 week follow up period

Treatment:

Drug: Insulin Glargine

Drug: Human Insulin Inhalation Powder

2

Experimental group

Description:

4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation 8 week follow up period

Treatment:

Drug: Insulin Glargine

Drug: Human Insulin Inhalation Powder