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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

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ClinicalTrials.gov Identifier: NCT00539396
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : October 14, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Technosphere Insulin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Change in blood glucose following a standard meal [ Time Frame: 0-300 minutes ]

Secondary Outcome Measures :
  1. Mean change from baseline HbA1c [ Time Frame: week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539396


Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Director: Robert Baughman, PhD Mannkind Corporation
More Information

ClinicalTrials.gov Identifier: NCT00539396     History of Changes
Other Study ID Numbers: MKC-TI-101
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

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