Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00356109
First received: July 21, 2006
Last updated: February 6, 2009
Last verified: February 2009

July 21, 2006
February 6, 2009
August 2006
May 2008   (final data collection date for primary outcome measure)
To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.
Complete list of historical versions of study NCT00356109 on ClinicalTrials.gov Archive Site
  • Insulin dose requirements [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Insulin antibody binding levels [ Time Frame: baseline, 1 month, 6 months, follow-up ] [ Designated as safety issue: No ]
  • To compare HbAlc change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess rate and incidence of hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Insulin dose requirements
  • Insulin antibody binding levels
  • To compare HbAlc after six month treatments
  • To assess rate and incidence of hypoglycemia
Not Provided
Not Provided
 
Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes
A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus.

This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes.

The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: Human Insulin Inhalation Powder
    patient specific dose, inhaled, before meals, 6 months
    Other Name: LY041001
  • Drug: Injectable insulin
    patient specific dose, injected, before meals, 6 months
  • Drug: Insulin Glargine
    patient specific dose, injectable, before meals, 6 months
  • Experimental: 1
    Interventions:
    • Drug: Human Insulin Inhalation Powder
    • Drug: Insulin Glargine
  • Active Comparator: 2
    Interventions:
    • Drug: Injectable insulin
    • Drug: Insulin Glargine
Comulada AL, Renard E, Nakano M, Rais N, Mao X, Webb DM, Milicevic Z. Efficacy and safety of AIR inhaled insulin compared to insulin lispro in patients with type 1 diabetes mellitus in a 6-month, randomized, noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S17-25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
494
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes for at least 24 months
  • Have an HbA1c less than or equal to 11%
  • Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
  • Non-smoker

Exclusion Criteria:

  • Require a daily total insulin dosage greater than 150 U at screening
  • Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
  • Systemic glucocorticoid therapy
  • Clinical signs or symptoms of liver disease, acute or chronic hepatitis
  • History of lung transplantation and/or lung cancer
  • Diagnosed with pneumonia in the 3 months prior to screening
  • History of renal transplantation
  • Active or untreated malignancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   France,   Germany,   India,   Italy,   Mexico,   Puerto Rico
 
NCT00356109
9627, H7U-MC-IDAV
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
February 2009

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