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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355849
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Human Insulin Inhalation Powder Drug: Insulin Glargine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine
Study Start Date : August 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Intensified Glargine
 Drug: Insulin Glargine
patient specific dose, injectable, before meals, 52 weeks
Experimental: 2
HIIP
 Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 52 weeks
Other Name: LY041001
Experimental: 3
Intensified Glargine plus HIIP
 Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 52 weeks
Other Name: LY041001

Drug: Insulin Glargine
patient specific dose, injectable, before meals, 52 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. To measure changes in HbA1c over time [ Time Frame: 24 weeks ]
  2. To assess insulin dose requirements [ Time Frame: 24 and 52 weeks ]
  3. To assess rate and incidence of hypoglycemia [ Time Frame: 24 and 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355849


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Alkermes, Inc.
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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Additional Information:
Lilly CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00355849    
Other Study ID Numbers: 9632
H7U-MC-IDBA ( Other Identifier: Eli Lilly and Company )
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs