Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00391209
Last Updated: 2018-03-09
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
379 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-10-31
Study Completion Date
2008-05-31
Brief Summary
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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.
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.
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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
Group Type
EXPERIMENTAL
simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
Intervention Type
DRUG
patient specific dose, inhaled, before meals,6 months
2
Group Type
EXPERIMENTAL
intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder
Intervention Type
DRUG
patient specific dose, inhaled, before meals, 6 months
Interventions
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simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals,6 months
Intervention Type
DRUG
intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 6 months
Intervention Type
DRUG
Other Intervention Names
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LY041001
LY 041001
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes mellitus for at least 6 months
* Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
* Patients who have been treated with the following regimen:
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.
* Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
* Patients who have been treated with the following regimen:
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
* 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
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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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Santa Ana, California, United States
Site Status
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Washington D.C., District of Columbia, United States
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Hollywood, Florida, United States
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New Port Richey, Florida, United States
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Biddeford, Maine, United States
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Bruges, , Belgium
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Brussels, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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La Roche-sur-Yon, , France
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La Rochelle, , France
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Rouen, , France
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Valenciennes, , France
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Ahmedabad, , India
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Chennai, , India
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Caguas, , Puerto Rico
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Ponce, , Puerto Rico
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Rio Piedras, , Puerto Rico
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A Coruña, , Spain
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Alicante, , Spain
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Alzira, , Spain
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Granada, , Spain
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Palma de Mallorca, , Spain
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Requena, , Spain
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Countries
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United States
Argentina
Austria
Belgium
France
India
Mexico
Puerto Rico
Spain
References
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Naegeli AN, Hayes RP. Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naive patients with type 2 diabetes. Int J Clin Pract. 2010 Jun;64(7):908-16. doi: 10.1111/j.1742-1241.2010.02363.x. Epub 2010 Mar 30.
Reference Type
DERIVED
Other Identifiers
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H7U-MC-IDAY
Identifier Type: OTHER
Identifier Source: secondary_id
9630
Identifier Type: -
Identifier Source: org_study_id
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