A Phase 3 interventional study of Human Insulin Inhalation Powder and Insulin Glargine in Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Completed at 19 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 142 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation 8 week follow up period
Drug: Human Insulin Inhalation Powder · Drug: Insulin Glargine
4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation 8 week follow up period
Drug: Human Insulin Inhalation Powder · Drug: Insulin Glargine
patient specific dose, inhaled, before meals, 24 weeks
Also known as: LY041001
patient specific dose, injectable, before meals, 24 weeks
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
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
Patient reported outcome of IDSQ
Time frame: week 12, 24, and 48
Patient reported outcome of preference questionnaire
Time frame: week 48
Patient reported outcome of Expectations About Insulin Therapy Questionnaire
Time frame: screening,baseline
Patient reported outcome of Experience with Insulin Therapy Questionnaire
Time frame: week 12, 24 and 48
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company