A 3 Month, Randomized, Open Label, Multi-Center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine

This study has been completed.

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00539396

Purpose

A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: Technosphere Insulin	Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin glargine Insulin aspart

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment
Official Title:	A Phase 2 Randomized, Open Label, Multi-Center Study of the Use of Prandial Inhaled Technosphere Insulin in Combination With Basal Subcutaneous Lantus as Basal Insulin Versus Prandial Subcutaneous NovoRapid in Combination With Basal Subcutaneous Lantus Insulin in Subjects With Type 1 Diabetes Mellitus

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

Change in blood glucose following a standard meal [ Time Frame: 0-300 minutes ]

Secondary Outcome Measures:

Mean change from baseline HbA1c [ Time Frame: week 12 ]

Estimated Enrollment:	110
Study Start Date:	March 2005
Study Completion Date:	December 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 diabetes currently receiving SC insulin at mealtimes for at least 3 months
BMI <40 kg/m squared
HbA1c greater than or equal to 7% and less than or equal to 11.5%
Serum creatinine less than 2 for males and less than 1.8 for females
Acceptable pulmonary function

Exclusion Criteria:

Significant hepatic disease
Previously diagnosed pulmonary disease, ketoacidosis of evidence of severe secondary complications of diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539396

Sponsors and Collaborators

Mannkind Corporation

Investigators

Study Director:

Robert Baughman, PhD

Mannkind Corporation

More Information

Study ID Numbers:	MKC-TI-101
Study First Received:	October 3, 2007
Last Updated:	October 3, 2007
ClinicalTrials.gov Identifier:	NCT00539396
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
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