Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus

Phase 3

Completed

Interventions: Drug: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
Drug: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
1	simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder	-
2	intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Insulin dose	throughout the study
Treatment satisfaction	6 months
Mean change in HbA1c from baseline to various endpoints.	6 months
Patient reported outcome from W-BQ12	screening,baseline,month 6
Patient safety	throughout the study
Patient reported outcome from DSC-R	screening,baseline, month 6
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

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Requena, Spain

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