Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

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. Identifier: NCT00308308
Recruitment Status : Completed
First Posted : March 29, 2006
Results First Posted : October 16, 2014
Last Update Posted : October 16, 2014
Information provided by (Responsible Party):
Mannkind Corporation

Brief Summary:
To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Condition or disease Intervention/treatment Phase
Diabetes, Type I Drug: Technosphere Insulin Drug: Active comparator Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 589 participants
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
Study Start Date : February 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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

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

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

  2. 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

  3. 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%

  4. 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.

  5. 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.

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

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

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

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

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 identifier (NCT number): NCT00308308

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Sponsors and Collaborators
Mannkind Corporation

Responsible Party: Mannkind Corporation Identifier: NCT00308308     History of Changes
Other Study ID Numbers: MKC-TI-009
First Posted: March 29, 2006    Key Record Dates
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
Hypoglycemic Agents
Physiological Effects of Drugs