Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
patient specific dose, inhaled, before meals, 24 weeks
DRUGInsulin Glargine
patient specific dose, injectable, before meals, 24 weeks
Sponsors
Eli Lilly and Company
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Patient Reported outcomes of DSC-R | screening,baseline, week 12,24, and 48 |
| Patient reported outcomes of DTSQS | screening,baseline, week 12, 24 and 48 |
| Patient reported outcome of IDSQ | week 12, 24, and 48 |
| Patient reported outcome of preference questionnaire | week 48 |
| Mean change in HbA1c from baseline to various timepoints | 56 weeks |
| Insulin dose requirements | 56 weeks |
| Assess inhaler reliability. | throughout the study |
| Hypoglycemia rate | throughout the study |
| Changes in body weight | every visit |
| Adverse events | throughout the study |
| Safety as assessed by total pulmonary function testing and fasting lipid profile | throughout the study |
| Patient reported outcome of Expectations About Insulin Therapy Questionnaire | screening,baseline |
| Patient reported outcome of Experience with Insulin Therapy Questionnaire | week 12, 24 and 48 |
| Patient-reported outcomes of W-BQ12 | screening,baseline, week 12,24, and 48 |
Countries
Brazil, India, Puerto Rico, Spain, United States
Outcome results
None listed