Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 Diabetes

Phase 3

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
1	Human Insulin Inhalation Powder	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
2	Human Insulin Inhalation Powder	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
1	Insulin Glargine	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
2	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean change in HbA1c from baseline to various timepoints	56 weeks
Insulin dose requirements	56 weeks
Adverse events	throughout the study
Patient-reported outcomes of W-BQ12	screening,baseline, week 12,24, and 48
Hypoglycemia rate	throughout the study
Safety as assessed by total pulmonary function testing and fasting lipid profile	throughout the study
Assess inhaler reliability.	throughout the study
Changes in body weight	every visit
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 preference questionnaire	week 48
Patient reported outcome of IDSQ	week 12, 24, and 48
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

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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Sabadell, Spain

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