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Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308308
First Posted: March 29, 2006
Last Update Posted: October 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mannkind Corporation
  Purpose
To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Condition Intervention Phase
Diabetes, Type I Drug: Technosphere Insulin Drug: Active comparator Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • Compare the Mean Change From Baseline to Week 52 in HbA1c [ Time Frame: Baseline to Week 52 ]

Secondary Outcome Measures:
  • Change From Baseline in Weight to Week 52 [ Time Frame: Baseline to Week 52 ]
    Change from baseline in weight at Week 52

  • Change From Baseline in Fasting Plasma Glucose to Week 52 [ Time Frame: Baseline to Week 52 ]
    Change from baseline in fasting plasma glucose at Week 52

  • Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0% [ Time Frame: Baseline to Week 52 ]
    Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%

  • Incidence of Total Hypoglycemia [ Time Frame: Baseline to Week 52 ]
    Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement <= 63 mg/dL, regardless of symptoms.

  • Incidence of Severe Hypoglycemia [ Time Frame: Baseline to Week 52 ]

    Severe hypoglycemia occurs when all 3 of the following occur simultaneously:

    • Subject requires the assistance of another person;
    • Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness);
    • Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR,
    • Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms.

  • Total Hypoglycemia Event Rate [ Time Frame: Baseline to Week 52 ]
    Number of Hypoglycemic Events/Total Subject Exposure Time (in months)

  • Severe Hypoglycemia Event Rate [ Time Frame: Baseline to Week 52 ]
    Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)


Enrollment: 589
Study Start Date: February 2006
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Technosphere Insulin
Drug: Technosphere Insulin
Inhalation, 15U/30U
Active Comparator: 2
Rapid-acting analogue insulin plus basal insulin glargine
Drug: Active comparator
sc injectable insulin

  Eligibility

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:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes for at least 1 year
  • Nonsmokers for prior 6 months
  • BMI less than or equal to 35kg/m2
  • HbA1c > or = 7% and < or = 11%
  • Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects
  • FEV1 > or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted
  • Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
  • Urine cotinine < or = 100 ng/mL

Exclusion Criteria:

  • History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
  • Evidence of severe complications of diabetes
  • Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal
  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): NCT00308308


  Show 129 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00308308     History of Changes
Other Study ID Numbers: MKC-TI-009
First Submitted: March 27, 2006
First Posted: March 29, 2006
Results First Submitted: July 22, 2014
Results First Posted: October 16, 2014
Last Update Posted: October 16, 2014
Last Verified: October 2014

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