Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes
This study has been completed.
Sponsored by: Mannkind Corporation
Information provided by: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00511602
  Purpose

Primary objective to evaluate the effect of a 12-week treatment period with prandial administration of Technosphere Insulin on glucose control in subjects with T2 DM. Secondary objective is to Evaluate the safety and tolerability of a 12-week treatment period of Technosphere Insulin and Technosphere Placebo.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Technosphere Insulin
Phase II

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of Inhaled Technosphere Insulin Compared to Technosphere Placebo in Patients With Type 2 Diabetes Mellitus Following Diabetes Education

Further study details as provided by Mannkind Corporation:

Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of T2 DM of >2 years and <12 years duration
  • Insulin treatment naive treated with diet/exercise or single/combination oral anti-diabetic agents, such as metformin, sulfonylurea, and/or thiazolidinediones
  • Stable regimen for >3 months of oral anti-diabetes medication prior to enrollment
  • HbA1c >6.6% and <10.5%
  • BMI <38 kg/m2
  • 18-80 years of age
  • Baseline FVC and FEV1 >80% and <120% of predicted normal as measured by spirometry
  • Baseline DLCO >80% and <120% of predicted normal

Exclusion Criteria:

  • Clinical diagnosis of type 1 diabetes mellitus
  • Subjects currently using insulin therapy or at the time of screening
  • Known hypersensitivity to the study drug or to drugs of similar chemical structures
  • Fasting plasma glucose >270 mg/dL without adequate explanation of a transient causality (screen could be repeated after a 2-week interim period)
  • History of severe or multiple allergies
  • History of tobacco or nicotine test at screening
  • Severe complications of diabetes including history of blindness from or Stage III or IV diabetic retinopathy, history of renal failure requiring dialysis or transplantation, history of amputation of limbs or digits related to diabetic vasculopathy
  • Treatment with another investigational drug within 3 months prior to study entry (and for the duration of the study)
  • Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, paranteral, and inhaled steroids, beta blockers, with the exception of beta blocker ophthalmic solutions for glaucoma or ocular hypertension, or hydrochlorothiazide (HCTZ) at doses >25 mg/day
  • Recent loss (within the 2 months prior to screening) of >5% of body weight
  • Evidence of moderate or greater ketones in urine or ketoacidosis at screening
  • History of chronic obstructive pulmonary disease or history of other known chronic pulmonary disease such as reactive airway disease, chronic bronchitis, emphysema, or asthma
  • Diagnosis of AIDS or ARC
  • A major psychiatric disorder that would have precluded satisfactory participation in this study
  • Subjects who had had a myocardial infarction or stroke within the preceding six months
  • Prior diagnosis of systemic autoimmune or collagen vascular disease requiring heart disease graded as Class III or Class IV according to New York Heart Association criteria
  • Prior treatment with, or participation in, a clinical study involving an inhaled insulin product
  • History of malignancy within 5 years of study entry (other than basal cell carcinoma)
  • Significant hepatic disease (as evidenced by ALT or AST >3 times the reference normal range or bilirubin >1.5 times the refernce normal range)
  • Significant renal disease (as evidenced by creatinine >1.5 mg/dL for males or >1.3 mg/dL for females), proteinuria as evidenced by greater than "small" by dipstick measurement or >2 grams in 24 hours, dialysis, or history of renal transplant
  • History of previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications indexed to this study:
Study ID Numbers: PDC-INS-0008
Study First Received: August 3, 2007
Last Updated: August 3, 2007
ClinicalTrials.gov Identifier: NCT00511602  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009