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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

This study has been completed.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00332488
First received: May 31, 2006
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  Purpose

to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • Change from baseline to Week 12 in glycated hemoglobin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 547
Study Start Date: December 2004
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 9or 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332488

  Show 120 Study Locations
Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Director: Anders Boss Mannkind Corporation
  More Information

No publications provided

Responsible Party: Anders Boss, MD, MFPM, Chief Medical Officer, MannKind Corporation
ClinicalTrials.gov Identifier: NCT00332488     History of Changes
Other Study ID Numbers: MKC-TI-103
Study First Received: May 31, 2006
Last Updated: October 1, 2009
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
Hypoglycemic Agents
Metformin
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013