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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Human Insulin Inhalation Powder; Drug: Insulin Glargine

• Registration Number: NCT00355849
• Lead Sponsor: Eli Lilly and Company

Brief Summary

A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder \[also known as AIR® Inhaled Insulin\]\[AIR® is a registered trademark of Alkermes,Inc.\] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. The present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily insulin glargine injections.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-07-21
• Study First Submitted QC: 2006-07-21
• Study First Posted: 2006-07-25
• Study Start: 2006-08
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Disposition First Submitted: 2018-03-07
• Disposition First Submitted QC: 2018-03-07
• Disposition First Posted: 2018-03-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 555

Inclusion Criteria

• type 2 diabetes mellitus
• one or more oral antihyperglycemic medications
• once-daily insulin glargine
• HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
• Non-smoker

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Exclusion Criteria

• taking a TZD dose greater than what is indicated
• more than two episodes of severe hypoglycemia during the 6 months prior
• Have had a lower respiratory infection in the 3 months prior
• systemic glucocorticoid therapy
• clinical signs or symptoms of liver disease, acute or chronic hepatitis
• history of renal transplantation
• Have an active or untreated malignancy
• Require more than 150 U/day of insulin glargine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Human Insulin Inhalation Powder	HIIP
3	Human Insulin Inhalation Powder	Intensified Glargine plus HIIP
1	Insulin Glargine	Intensified Glargine
3	Insulin Glargine	Intensified Glargine plus HIIP

Primary Outcome Measures

Name	Time	Method
To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin.	24 weeks

Secondary Outcome Measures

Name	Time	Method
To assess rate and incidence of hypoglycemia	24 and 52 weeks
To assess insulin dose requirements	24 and 52 weeks
To measure changes in HbA1c over time	24 weeks

Trial Locations

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.; 🇬🇧 Manchester, United Kingdom