Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP) (IDAP)

Lilly

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY041001 (HIIP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099515

9523

H7U-MC-IDAP

Details and patient eligibility

About

The purpose of this study is to compare intensive and standard training for human insulin inhalation powder in patients with type 2 diabetes.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes for at least 12 months
• Age 18 or older.
• Taking at least 1 oral antihyperglycemic medication.
• Have an HbA1C between 7.5 and 12.
• Be a nonsmoker

Exclusion criteria

• Body Mass Index (BMI) greater than 40.
• Have frequent episodes of severe hypoglycemia.
• Have advanced autonomic neuropathy.
• Have history of asthma.
• Have chronic obstructive pulmonary disease (COPD).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: LY041001 (HIIP)

Drug: LY041001 (HIIP)

B

Experimental group

Treatment:

Drug: LY041001 (HIIP)

Drug: LY041001 (HIIP)