Diabetes Mellitus, Type 2
Conditions
Brief summary
This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups: Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day. Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.
Interventions
DRUGsimplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals,6 months
DRUGintensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 6 months
Sponsors
Alkermes, Inc.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus for at least 6 months * Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening. * Patients who have been treated with the following regimen: One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones \[TZDs\]), AND have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months, AND are candidates for insulin therapy, in the opinion of the investigator.
Exclusion criteria
* Pregnancy * Smoker * History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry * Diagnosed with pneumonia in the 3 months prior to screening * Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry * History of renal transplantation * History of lung transplantation * Active or untreated malignancy * Treated with Incretin mimetics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Patient safety | throughout the study |
| Patient reported outcome from W-BQ12 | screening,baseline,month 6 |
| Treatment satisfaction | 6 months |
| Insulin dose | throughout the study |
| Mean change in HbA1c from baseline to various endpoints. | 6 months |
| Patient reported outcome from DTSQS | screening,baseline, month 6 |
| Patient reported outcome from IDSQ | Month 1, 2 and 6 |
| Patient reported outcome from Expectations About Insulin Therapy Questionnaire | baseline, screening, month 6 |
| Patient reported outcome from DSC-R | screening,baseline, month 6 |
Countries
Argentina, Austria, Belgium, France, India, Mexico, Puerto Rico, Spain, United States
Outcome results
None listed