Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes
NCT ID: NCT00355849
Last Updated: 2019-09-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
555 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-08-31
Study Completion Date
2008-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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1
Intensified Glargine
Group Type
EXPERIMENTAL
Insulin Glargine
Intervention Type
DRUG
patient specific dose, injectable, before meals, 52 weeks
2
HIIP
Group Type
EXPERIMENTAL
Human Insulin Inhalation Powder
Intervention Type
DRUG
patient specific dose, inhaled, before meals, 52 weeks
3
Intensified Glargine plus HIIP
Group Type
EXPERIMENTAL
Human Insulin Inhalation Powder
Intervention Type
DRUG
patient specific dose, inhaled, before meals, 52 weeks
Insulin Glargine
Intervention Type
DRUG
patient specific dose, injectable, before meals, 52 weeks
Interventions
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Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 52 weeks
Intervention Type
DRUG
Insulin Glargine
patient specific dose, injectable, before meals, 52 weeks
Intervention Type
DRUG
Other Intervention Names
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LY041001
Eligibility Criteria
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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
* 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
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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Sponsor Role
collaborator
Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Fresno, California, United States
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Pomona, California, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Peoria, Illinois, United States
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New Albany, Indiana, United States
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Topeka, Kansas, United States
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Ann Arbor, Michigan, United States
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Grand Rapids, Michigan, United States
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Omaha, Nebraska, United States
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Nashua, New Hampshire, United States
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Salt Lake City, Utah, United States
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Olympia, Washington, United States
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Curitiba, , Brazil
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São Paulo, , Brazil
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Red Deer, Alberta, Canada
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Saint John, New Brunswick, Canada
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Cambridge, Ontario, Canada
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Thornhill, Ontario, Canada
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Aschaffenburg, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Hamburg, , Germany
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Mainz, , Germany
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Münster, , Germany
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Rodgau, , Germany
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Witten, , Germany
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Bangalore, , India
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Chennai, , India
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Indore, , India
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Ludhiana, , India
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Holon, , Israel
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Nahariya, , Israel
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Tel Litwinsky, , Israel
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Carolina, , Puerto Rico
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Manatí, , Puerto Rico
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San Juan, , Puerto Rico
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Toa Baja, , Puerto Rico
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Moscow, , Russia
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Saint Petersburg, , Russia
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Pretoria, , South Africa
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Seoul, , South Korea
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Suwon, , South Korea
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A Coruña, , Spain
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Alicante, , Spain
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Alzira, , Spain
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Barcelona, , Spain
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Dos Hermanas, , Spain
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Madrid, , Spain
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Palma de Mallorca, , Spain
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Middlesbrough, Cleveland, United Kingdom
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Blackburn, East Lancashire, United Kingdom
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Penarth, South Glamorgan, United Kingdom
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Swansea, Wales, United Kingdom
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Livingston, West Lothian, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Manchester, , United Kingdom
Site Status
Countries
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United States
Brazil
Canada
Germany
India
Israel
Puerto Rico
Russia
South Africa
South Korea
Spain
United Kingdom
References
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Rosenstock J, Eliaschewitz FG, Heilmann CR, Muchmore DB, Hayes RP, Belin RM. Comparison of prandial AIR inhaled insulin alone to intensified insulin glargine alone and to AIR insulin plus intensified insulin glargine in patients with type 2 diabetes previously treated with once-daily insulin glargine. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S63-73. doi: 10.1089/dia.2009.0059.
Reference Type
RESULT
Other Identifiers
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H7U-MC-IDBA
Identifier Type: OTHER
Identifier Source: secondary_id
9632
Identifier Type: -
Identifier Source: org_study_id
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Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
NCT02414958
COMPLETED
PHASE3
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
NCT05463744
COMPLETED
PHASE3
Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
NCT00308737
COMPLETED
PHASE3
Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
NCT01445951
COMPLETED
PHASE3
INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes
NCT05904743
COMPLETED
PHASE4
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study
NCT03143816
COMPLETED
PHASE4
Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
NCT02580591
COMPLETED
PHASE3
A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382
NCT03341013
COMPLETED
PHASE1
A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
NCT05433584
ACTIVE_NOT_RECRUITING
PHASE4
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.
NCT00143104
COMPLETED
PHASE2