Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00539890
First received: October 3, 2007
Last updated: October 12, 2009
Last verified: October 2009

October 3, 2007
October 12, 2009
November 2005
Not Provided
Mean change in HbA1c from baseline to treatment week 24 [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT00539890 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus
A Phase 3 Randomized, Open Label, Multi-Center Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin

To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c >7.0% and <11.5%.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Type 2
Drug: Technosphere Insulin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
0
July 2006
Not Provided

Inclusion Criteria:

  • At least 2 years since diagnosis of type 2 diabetes mellitus
  • Received subcutaneous (sc) insulin for at least 3 months
  • Body Mass Index <44 kg/m2
  • HbA1c>7.0% and <11.5%
  • Serum creatinine <2.0 mg/dL for males and <1.8 mg/dL for females
  • Baseline FVC and FEV1>70% and < 125% of predicted normal

Exclusion Criteria:

  • Significant hepatic disease (AST/ALT3 x ULN)
  • Diagnosis of Type 1 diabetes
  • Severe complications of diabetes
  • History of moderate to severe ketoacidosis within the past 3 months
  • Upper respiratory infection in the last 15 days or a lower respiratory infection in the past 30 days
  • Diagnosis of HIV
  • Positive serology for hepatitis B or C
  • COPD, emphysema, or asthma
  • Current smokers or smoking history within the past 6 months
  • Major psychiatric disorder precluding satisfactory completion of protocol
  • Clinically significant heart disease disease, stroke or heart attack within the past 6 months
  • Treatment with an investigational drug within 30 days
  • Previous treatment with Technosphere/Insulin
  • History of malignancy in the past 5 years except basal cell carcinoma
  • Anemia (hemoglobin <10.5 g/dL for females and <11.5 g/dL (for males)
  • Women who were pregnant of lactating
  • History of hypersensitivity to drugs resembling FDKP carrier products
  • Treatment with another inhaled insulin product during the duration of the study
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00539890
MKC-TI-014
Not Provided
Not Provided
Mannkind Corporation
Not Provided
Study Director: Robert Baughman, PhD Mannkind Corporation
Mannkind Corporation
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP