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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 (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00332488
First received: May 31, 2006
Last updated: October 9, 2014
Last verified: October 2014
  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:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    (Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332488

  Show 120 Study Locations
Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Director: For MannKind sponsored trials, the Overall Study Official is the Chief Scientific Officer Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00332488     History of Changes
Other Study ID Numbers: MKC-TI-103
Study First Received: May 31, 2006
Results First Received: July 22, 2014
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014