Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus
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About
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.
Enrollment
Sex
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
379 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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