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.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00539396
First received: October 3, 2007
Last updated: October 12, 2009
Last verified: October 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

No publications provided

ClinicalTrials.gov Identifier: NCT00539396     History of Changes
Other Study ID Numbers: MKC-TI-101
Study First Received: October 3, 2007
Last Updated: October 12, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014