Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Alkermes
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00325364

Purpose

This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Human Insulin Inhalation Powder Drug: Injectable insulin	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To compare inhaled human insulin to injectable insulin over time with respect to change on body weight [ Time Frame: baseline and every visit ] [ Designated as safety issue: No ]
To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction [ Time Frame: baseline, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c [ Time Frame: baseline and every visit ] [ Designated as safety issue: No ]
To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To test dose titration methods [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To assess inhaler reliability [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]

Enrollment:	415
Study Start Date:	April 2006
Study Completion Date:	May 2008
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, 24 months
2: Active Comparator	Drug: Injectable insulin patient specific dose, injectable, before meals, 24 months

Eligibility

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

Criteria

Inclusion Criteria:

Type 2 diabetes
Non smoker
Normal lung function

Exclusion Criteria:

Pulmonary, hepatic, or renal disease
Congestive heart failure
Active malignancy
Systemic glucocorticoid therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325364

Show 43 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:	9626, H7U-MC-IDAU
Study First Received:	May 10, 2006
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00325364
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009