Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00308308
First received: March 27, 2006
Last updated: October 9, 2014
Last verified: October 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Weight to Week 52 [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    Change from baseline in weight at Week 52

  • Change From Baseline in Fasting Plasma Glucose to Week 52 [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    Number of Hypoglycemic Events/Total Subject Exposure Time (in months)

  • Severe Hypoglycemia Event Rate [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT00308308

  Show 129 Study Locations
Sponsors and Collaborators
Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00308308     History of Changes
Other Study ID Numbers: MKC-TI-009
Study First Received: March 27, 2006
Results First Received: July 22, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014