This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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.
Information provided by:
Mannkind Corporation Identifier:
First received: October 3, 2007
Last updated: October 12, 2009
Last verified: October 2009
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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00539396

Sponsors and Collaborators
Mannkind Corporation
Study Director: Robert Baughman, PhD Mannkind Corporation
  More Information Identifier: NCT00539396     History of Changes
Other Study ID Numbers: MKC-TI-101
Study First Received: October 3, 2007
Last Updated: October 12, 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
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on June 23, 2017