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Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes

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: NCT00332488
Recruitment Status : Completed
First Posted : June 1, 2006
Results First Posted : October 16, 2014
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation

Study Description
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Brief Summary:
to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Technosphere Insulin Drug: Metformin & Secretagogues Drug: Technosphere Insulin & Metformin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 547 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue.
Study Start Date : December 2004
Actual Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Technosphere Insulin
 Drug: Technosphere Insulin
Inhalation, 15U/30U, prandial
Active Comparator: 2
Metformin & Secretagogues
 Drug: Metformin & Secretagogues
Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
Experimental: 3
Technosphere & Metformin
 Drug: Technosphere Insulin & Metformin
Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets


Outcome Measures
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Primary Outcome Measures :
  1. Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue [ Time Frame: Baseline to Week 12 ]
    (Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)

  2. Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment) [ Time Frame: Week 24 ]

Eligibility Criteria
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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:

  • Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months
  • Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
  • Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
  • HbA1c >or= to 7.5% and < or= to 11.0%
  • BMI < or = to 40kg/m2.
  • FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70%

Exclusion Criteria:

  • Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks
  • Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects
  • History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
  • Evidence of serious complications of diabetes (e.g. autonomic neuropathy)
Contacts and Locations
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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): NCT00332488


Locations
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Sponsors and Collaborators
Mannkind Corporation
Investigators
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Study Director: For MannKind sponsored trials, the Overall Study Official is the Chief Scientific Officer Mannkind Corporation
More Information
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Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00332488    
Other Study ID Numbers: MKC-TI-103
First Posted: June 1, 2006    Key Record Dates
Results First Posted: October 16, 2014
Last Update Posted: October 16, 2014
Last Verified: October 2014
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
Metformin
Secretagogues
Hypoglycemic Agents
Physiological Effects of Drugs