Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Alkermes
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00356109

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: Human Insulin Inhalation Powder Drug: Injectable insulin Drug: Insulin Glargine	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	490
Study Start Date:	August 2006
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Human Insulin Inhalation Powder patient specific dose, inhaled, before meals, 6 months Drug: Insulin Glargine patient specific dose, injectable, before meals, 6 months
2: Active Comparator	Drug: Injectable insulin patient specific dose, injected, before meals, 6 months Drug: Insulin Glargine patient specific dose, injectable, before meals, 6 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356109

Show 37 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Alkermes

Investigators

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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	9627, H7U-MC-IDAV
Study First Received:	July 21, 2006
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00356109
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009