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

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00355849
First received: July 21, 2006
Last updated: October 13, 2008
Last verified: October 2008

July 21, 2006
October 13, 2008
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • To assess insulin dose requirements [ Time Frame: 24 and 52 weeks ] [ Designated as safety issue: No ]
  • To assess rate and incidence of hypoglycemia [ Time Frame: 24 and 52 weeks ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Canada,   Germany,   India,   Israel,   Korea, Republic of,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   United Kingdom
 
NCT00355849
9632, H7U-MC-IDBA
Not Provided
Chief Medical Officer, Eli Lilly
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
October 2008

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