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

Eli Lilly and Company142 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

Diabetes Mellitus, Type 2

Interventions

Human Insulin Inhalation PowderDRUG

patient specific dose, inhaled, before meals, 24 weeks

Insulin GlargineDRUG

patient specific dose, injectable, before meals, 24 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Outcomes

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.

Time frame: 56 weeks

Secondary Outcomes

Mean change in HbA1c from baseline to various timepoints

Time frame: 56 weeks

Insulin dose requirements

Time frame: 56 weeks

Patient-reported outcomes of W-BQ12

Time frame: screening,baseline, week 12,24, and 48

Hypoglycemia rate

Time frame: throughout the study

Changes in body weight

Time frame: every visit

Adverse events

Time frame: throughout the study

Safety as assessed by total pulmonary function testing and fasting lipid profile

Time frame: throughout the study

Assess inhaler reliability.

Time frame: throughout the study

Patient Reported outcomes of DSC-R

Time frame: screening,baseline, week 12,24, and 48

Patient reported outcomes of DTSQS

Time frame: screening,baseline, week 12, 24 and 48

Data from ClinicalTrials.gov

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Greenbrae, California, United States

Topeka, Kansas, United States

Toms River, New Jersey, United States

Albuquerque, New Mexico, United States

New Braunfels, Texas, United States

San Antonio, Texas, United States

Porto Alegre, Brazil

São Paulo, Brazil

Indore, India

Kochi, India

...and 9 more locations