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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
History of Changes
  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:

U.S. FDA Resources

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
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
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
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 May 16, 2013