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.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: Technosphere Insulin
  • Inhalation, 15U/30U, prandial
• Drug: Metformin & Secretagogues
  • Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
• Drug: Technosphere Insulin & Metformin
  • Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Technosphere Insulin
• Active Comparator: 2
  • Metformin & Secretagogues
• Experimental: 3
  • Technosphere & Metformin

Primary Measures

• Change from baseline to Week 12 in glycated hemoglobin
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Change in HbA1c from baseline
  • Time Frame: 24 weeks
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mannkind Corporation

Overall Clinical Trial Officials and Contacts

Anders Boss Study Director Mannkind Corporation  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00332488

Study ID Number: MKC-TI-103

ClinicalTrials.gov Identifier: NCT00332488

Health Authority: United States: Food and Drug Administration