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OpenTrials
Completed

NCT Number: NCT00308308

Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

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

Completed

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Key information

Conditions

Diabetes, Type I Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Interzonal de Agudos Pedro Fiorito, Avellaneda, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technosphere Insulin

Drug

Inhalation, 15U/30U

Active Comparator

Drug

sc injectable insulin

Primary outcomes

  1. Compare the Mean Change From Baseline to Week 52 in HbA1c

    Time frame: Baseline to Week 52

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Mannkind Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 29, 2006
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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