Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00308737
First received: March 28, 2006
Last updated: October 1, 2009
Last verified: October 2009
  Purpose

Pulmonary Safety in Diabetics with T/I


Condition Intervention Phase
Diabetes, Type I
Diabetes Type 2
Drug: Technosphere Insulin
Drug: Usual Care
Other: No Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control.

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • To evaluate and compare changes in pulmonary function [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate and compare glycemic control [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2343
Study Start Date: June 2005
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Technosphere Insulin
Drug: Technosphere Insulin
Inhalation, 15U/30U
2
Usual care
Drug: Usual Care
Subjects will receive antidiabetes treatment at the discretion of their physicians
No Intervention: 3
Subjects without abnormalities in glucose control
Other: No Intervention
No intervention

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For All Subjects:

    • Nonsmoking
    • Body mass index <42 kg/m2
    • FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening,
    • No abnormalities in screening pulmonary radiology
  • For Subjects with diabetes mellitus:

    • Type 1 or type 2 diabetes for at least 2 years
    • HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %
  • For Subjects without abnormalities in glucose control:

    • No history of diabetes
    • Normal results from a formal glucose tolerance test

Exclusion Criteria:

  • History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
  • Significant renal, hepatic, or cardiac disease
  • Women who are pregnant, lactating, or planning on becoming pregnant
  • Subjects who have participated in studies of other investigational drugs within the previous 3 months
  • Evidence of severe 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 ClinicalTrials.gov identifier: NCT00308737

  Show 176 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Anders Boss, MD, MFPM, Chief Medical Officer & Senior Vice President, MannKind Corporation
ClinicalTrials.gov Identifier: NCT00308737     History of Changes
Other Study ID Numbers: MKC-TI-030
Study First Received: March 28, 2006
Last Updated: October 1, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014