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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00355849
First Posted: July 25, 2006
Last Update Posted: November 22, 2016
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.
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
July 21, 2006
July 25, 2006
November 22, 2016
August 2006
June 2008   (Final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00355849 on ClinicalTrials.gov Archive Site
  • To measure changes in HbA1c over time [ Time Frame: 24 weeks ]
  • To assess insulin dose requirements [ Time Frame: 24 and 52 weeks ]
  • To assess rate and incidence of hypoglycemia [ Time Frame: 24 and 52 weeks ]
  • To measure changes in HbA1c over time
  • To assess insulin dose requirements
  • To assess rate and incidence of hypoglycemia
Not Provided
Not Provided
 
Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • Experimental: 1
    Intensified Glargine
    Intervention: Drug: Insulin Glargine
  • Experimental: 2
    HIIP
    Intervention: Drug: Human Insulin Inhalation Powder
  • Experimental: 3
    Intensified Glargine plus HIIP
    Interventions:
    • Drug: Human Insulin Inhalation Powder
    • Drug: Insulin Glargine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
555
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   Germany,   India,   Israel,   Korea, Republic of,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   United Kingdom,   United States
 
 
NCT00355849
9632
H7U-MC-IDBA ( Other Identifier: Eli Lilly and Company )
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Eli Lilly and Company
Eli Lilly and Company
Alkermes, Inc.
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
Eli Lilly and Company
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP