Official Title: “A Phase3, Multi-Center, Open-Label, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With Lantus® Versus Humalog® in Combination With Lantus® in Subjects With Type 1 Diabetes Mellitus Over a 16-Week Treatment Period”

The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.

Study Type: Interventional

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

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Technosphere Insulin
  • Technosphere Insulin Inhalation Powder 15U or 30U
• Drug: Humalog
  • Humalog autopen cartridges pre-filled with 3mL (300 units)
• Drug: Lantus
  • Lantus-injectible supplied as 3mL (300 units)pens.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Technosphere Insulin Inhalation Powder in combination with Lantus
• Experimental: 2
  • Humalog in combination with Lantus

Primary Measures

• The primary efficacy endpoint is the change from Visit 5 to Visit 14 in A1c.
  • Time Frame: 16 Weeks
    Safety Issue?: No

Secondary Measures

• Proportion of subjects who achieve an A1c of less than or equal to 6.5%
  • Time Frame: 16 Weeks
    Safety Issue?: No
• Proportion of subjects who achieve an A1c of less than or equal to 7.0 %
  • Time Frame: 16 Weeks
    Safety Issue?: No
• Proportion of subjects who achieve an A1c of less than or equal to 7.0%, AND do not have any episodes of severe hypoglycemia
  • Time Frame: 16 Weeks
    Safety Issue?: No
• Area under the glucose concentration curve (AUC0-240 min), based on plasma glucose concentrations measured at -30, 0, 30, 60, 90, 105, 120, 180, and 240 min following the Meal Challenge(s)
  • Time Frame: 240 Minutes
    Safety Issue?: No
• Responder rate as measured by the number of subjects who attain 2-hour PPG levels of < 180 mg/dL (10.0 mmol/L), and < 140 mg/dL (7.8 mmol/L) following Meal Challenges
  • Time Frame: 2 Hours
    Safety Issue?: No
• 7-point blood glucose (BG) profiles at regular intervals
  • Time Frame: 16 Weeks
    Safety Issue?: No
• CGM parameters
  • Time Frame: 16 Weeks
    Safety Issue?: No
• Body weight
  • Time Frame: 16 Weeks
    Safety Issue?: No
• Subject treatment satisfaction
  • Time Frame: 16 Weeks
    Safety Issue?: No

Key Inclusion Criteria:

• Non-smoking
• Clinical diagnoses of type 1 diabetes mellitus
• Currently receiving subcutaneous (sc) insulin therapy at a total daily dose (TDD) <
• 1.5 IU/kg/day.
• Body mass index (BMI) of less than or equal to 30 kg/m2. A1c greater than 7.0% and less than or equal to 9.0%.
• Subjects must have a C-peptide level of less than or equal to 0.30 pmol/mL.

Key Exclusion Criteria:

• History of insulin pump within 6 weeks of Screening/Visit 1 (Week -5).
• Treatment with any type of anti-diabetic drugs, other than sc insulin, within the preceding 12 weeks.
• History of chronic obstructive pulmonary disease (COPD), clinically proven asthma, and/or any other clinically important pulmonary disease (eg, obstructive sleep apnea) confirmed by pulmonary function testing, and/or radiologic findings.
• Significant improvement in pre- to post- bronchodilator spirometry (defined as an increase of 12% and 200 mL in FEV1 or FVC at Visit 1).
• Evidence of serious complications of diabetes.
• Use of medications prescribed for weight loss within 12 weeks of Visit 1.

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, MD Study Director Mannkind Corporation  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00700622

Study ID Number: MKC-TI-117

ClinicalTrials.gov Identifier: NCT00700622

Health Authority: United States: Food and Drug Administration