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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00539890
Recruitment Status : Completed
First Posted : October 5, 2007
Last Update Posted : October 14, 2009
Sponsor:
Information provided by:
Mannkind Corporation

Brief Summary:
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%.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Drug: Technosphere Insulin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Mean change in HbA1c from baseline to treatment week 24 [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539890


Locations
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Sponsors and Collaborators
Mannkind Corporation
Investigators
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Study Director: Robert Baughman, PhD Mannkind Corporation

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ClinicalTrials.gov Identifier: NCT00539890    
Other Study ID Numbers: MKC-TI-014
First Posted: October 5, 2007    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs