Safety and Efficacy of Technosphere Insulin Inhalation Powder When an Optimal Dose is Taken With Varied Carbohydrate Intake

This study is not yet open for participant recruitment.

Verified by Mannkind Corporation, September 2008

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00747006

Purpose

The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1	Drug: Techonosphere Insulin Inhalation Powder	Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Single-Center, Open-Label, Pharmacodynamic Clinical Trial to Evaluate the Effect of Technosphere® Insulin Inhalation Powder on Postprandial Glucose Levels in Subjects With Type 1 and Type 2 Diabetes Mellitus Ingesting Meals With Varied Carbohydrate Content

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

To evaluate postprandial glucose (PPG) excursions following the ingestion of lunch or breakfast meals with varying carbohydrate content [ Time Frame: 15 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Techonosphere Insulin Inhalation Powder 15U or 30U

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnoses of type 1 or type 2 diabetes mellitus
FBG 70, 120 mg/dL and glycated hemoglobin (A1C) > 6.5% and = 9.0%.
Body mass index (BMI) of = 35 kg/m2
Non-smokers (never smoked or former smokers [= 6 months since cessation]) and a urine cotinine level = 100 ng/dL
FEV1 = 70% Third National Health and Nutrition Examination Survey (NHANES III) Predicted; pre-bronchodilator FEV1 as a percentage of forced vital capacity (FEV1/FVC) = 70%
For subjects with type 2 diabetes mellitus: Currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment

Exclusion Criteria:

History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by PFT and/or radiologic findings
Elevated liver function test (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times the normal reference range or bilirubin > 1.5 times the reference range)
Previous use of Exubera; use of Symlin (pramlintide acetate) and/or Byetta (exenatide) within the past 12 weeks
Unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
Exposure to any investigational product(s) in the past 12 weeks
For subjects with type 2 diabetes mellitus: In subjects taking metformin, serum creatinine > 1.4 mg/dL in female subjects and > 1.5 mg/dL in male subjects

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747006

Locations

United States, California
Sansum Medical Research Institute
Santa Barbara, California, United States, 93105

Sponsors and Collaborators

Mannkind Corporation

More Information

Responsible Party:	MannKind Corporation ( Anders Boss, Chief Medical Officer & Senior Vice President )
Study ID Numbers:	MKC-TI-119
Study First Received:	September 3, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00747006
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
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 14, 2009