Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00511602
First received: August 3, 2007
Last updated: April 27, 2012
Last verified: April 2012
  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
Drug: Technosphere Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Inhaled Technosphere Insulin Compared to Technosphere Placebo in Patients With Type 2 Diabetes Mellitus Following Diabetes Education

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • HbA1c change from baseline (week 2) to end of treatment (week 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the plasma glucose concentration versus time (AUCglucose) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    Timepoints: 0, 30, 60, and 120 minutes after TI administration

  • Maximum glucose concentration (Cmax) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    Timepoints: 0, 30, 60, and 120 minutes after TI administration

  • Time to maximum glucose concentration (tmax) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    Timepoints: 0, 30, 60, and 120 minutes after TI administration

  • Area under the plasma glucose concentration versus time (AUCglucose) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration

  • Maximum glucose concentration (Cmax) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration

  • Time to maximum glucose concentration (tmax) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration

  • Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: December 2003
Study Completion Date: December 2005
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Technosphere Insulin Inhalation Powder Drug: Technosphere Insulin
Technosphere Insulin Inhalation Powder
Placebo Comparator: Technosphere Inhalation Powder Drug: Technosphere Placebo
Technosphere Inhalation Powder

  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, parenteral, 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 reference 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
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.

No Contacts or Locations Provided
  More Information

No publications provided by Mannkind Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00511602     History of Changes
Other Study ID Numbers: PDC-INS-0008
Study First Received: August 3, 2007
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014