Clinical trial NCT00747006: Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake
Official title: A Phase 2, Single-Center, Open-Label, Pharmacodynamic Clinical Trial to Evaluate the Effect of Technosphere® Insulin Inhalation Powder Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder) on Postprandial Glucose Levels in Subjects With Type 1 and Type 2 Diabetes Mellitus Ingesting Meals With Varied Carbohydrate Content
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if, once a favorable dose of TI Inhalation Powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content. Patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). The 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnoses of type 1 or type 2 diabetes mellitus
* Fasting Plasma Glucose (FPG) 80, 140 mg/dL and glycated hemoglobin (A1C) \> 6.5% and \< or = 10.0%.
* Body mass index (BMI) of \< or = 40 kg/m2
* Non-smokers (never smoked or former smokers \[= 6 months since cessation\]) and a urine cotinine level \< or = 100 ng/dL
* Forced expiratory volume in 1 second (FEV1) = 70% Third National Health and Nutrition Examination Survey (NHANES III) Predicted; pre-bronchodilator FEV1 as a percentage of forced vital capacity (FEV1/Forced vital capacity(FVC)) = 70%
* For subjects with type 2 diabetes mellitus: Currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment

Exclusion Criteria:

* History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (PFT) and/or radiologic findings
* Elevated liver function test (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 3 times the normal reference range or bilirubin \> 1.5 times the reference range)
* Previous use of Exubera; use of Symlin (pramlintide acetate) and/or Byetta (exenatide) within the past 12 weeks
* Unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy)
* Exposure to any investigational product(s) in the past 12 weeks
* For subjects with type 2 diabetes mellitus: In subjects taking metformin, serum creatinine \> 1.4 mg/dL in female subjects and \> 1.5 mg/dL in male subjects

Primary outcomes:
measure: Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
timeFrame: 0 to 240 minutes
measure: Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
timeFrame: 0 to 240 minutes
measure: Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
timeFrame: 0 to 240 minutes
measure: Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
timeFrame: 0 to 240 minutes
measure: Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)
timeFrame: 0 to 240 minutes
measure: Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)
timeFrame: 0 to 240 minutes
measure: Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)
timeFrame: 0 to 240 minutes
measure: Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)
timeFrame: 0 to 240 minutes
Secondary outcomes:
measure: Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)
timeFrame: 0 to 240 minutes
measure: Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)
timeFrame: 0 to 240 minutes
measure: Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)
timeFrame: 0 to 240 minutes
measure: Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)
timeFrame: 0 to 240 minutes
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Medical Research Institute
state: California
Study officials:
References: