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Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge

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ClinicalTrials.gov Identifier: NCT01902121
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation

Tracking Information
First Submitted Date  ICMJE July 15, 2013
First Posted Date  ICMJE July 18, 2013
Last Update Posted Date December 12, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2013)
Area-under-the-serum insulin concentration versus time curve (AUC0-240min [ Time Frame: 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01902121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge
Official Title  ICMJE A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges
Brief Summary A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Technosphere® Insulin 10U + 20U
    Inhaled Insulin
  • Drug: Technosphere® Insulin 30U
    Inhaled Insulin
Study Arms  ICMJE
  • Experimental: TI 30 units (10 unit + 20 unit
    Technosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge
    Intervention: Drug: Technosphere® Insulin 10U + 20U
  • Experimental: TI 30 units (30 unit cartridge
    Technosphere® Insulin 30 units given as one 30 unit cartridge
    Intervention: Drug: Technosphere® Insulin 30U
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2014)
40
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2013)
36
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
  • No smoking in the past 6 months (including cigarettes, cigars, and pipes)
  • Urine cotinine testing < 100 ng/mL
  • Body mass index < 32 kg/m2
  • Completion of informed consent form

Exclusion Criteria:

  • FBG > 100 mg/dL
  • Clinically significant active or chronic illness
  • History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant chronic lung disease
  • Respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit
  • Subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01902121
Other Study ID Numbers  ICMJE MKC-TI-178
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mannkind Corporation
Study Sponsor  ICMJE Mannkind Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mannkind Corporation
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP