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A Study to Evaluate Insulin in the Blood After Inhalation of a Dry Powder Insulin Formulation (Called Technosphere®/Insulin) in Non-diabetic Patients With & Without Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT01021891
First received: November 25, 2009
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

Trial will include 40 subjects and consists of 3 visits: Screening, Treatment and Follow up. A euglycemic clamp procedure and Technosphere®/Insulin (T/I) administration will occur at Visit 2 for both COPD and non COPD subjects.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Technosphere®/Insulin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b, Single-Dose, Open-Label, Parallel, Controlled Pharmacology Trial of Inhaled Technosphere®/Insulin in Non-Diabetic Subjects With COPD Versus Matched Non-Diabetic Subjects Without COPD.

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • To evaluate the pharmacokinetic disposition of serum insulin and serum fumaryl diketopiperazine following dosing with 30 U T/I, as measured via Area Under the Curve serum insulin and AUC 0-480 min serum FDKP [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: July 2006
Study Completion Date: November 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-Diabetic Subj. w/o COPD
Single dose, 30 units
Drug: Technosphere®/Insulin
Experimental: Non-Diabetic Subj. with COPD
Single dose, 30 units
Drug: Technosphere®/Insulin

Detailed Description:

Trial objectives are to evaluate the impact of a defined lung disease (COPD) on pharmacokinetic parameters of insulin and fumaryl diketopiperazine (FDKP) after inhalation of Technosphere®/Insulin (T/I), the investigational medicinal product. 40 non diabetic subjects, 20 COPD and 20 age/gender/BMI-matched non COPD subjects will participate in 3 visits: Visit 1 (screening), Visit 2 (subjects will undergo a euglycemic clamp procedure and be dosed with T/I) and Visit 3 (follow up visit).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects minimum 18 and maximum 70 years of age
  • Body Mass Index (BMI) = 36 kg/m2
  • Subjects with COPD: Diagnosis of COPD (emphysema and/or chronic bronchitis),
  • smoking history =10 years, chronic cough present intermittently or daily with or without sputum and/or dyspnea upon exertion.
  • Subjects with COPD: Pulmonary Function Tests - FEV1 =50% (NHANES) III
  • Predicted; FEV1/FVC < 70 % (NHANES) III; TLC =80% of Predicted (ITS) and DLco(unc) =50% of Predicted (Miller)
  • Subjects without COPD: PFTs: FEV1 = 70% NHANES III Predicted; TLC =80% of
  • Predicted (ITS) and DLco(unc) =80% of Predicted (Miller)

Exclusion Criteria:

  • History of pre-diabetes or diabetes
  • Previous or current treatment with any anti-diabetic drugs
  • Serum creatinine > 2.0 mg/dL in males and > 1.8 mg/dL in females
  • Active smokers defined as having smoked their last cigarette, pipe, and/or cigar without the previous 6 months
  • Previous exposure to any inhaled insulin product or investigational medicines/devices within the previous 30 days prior to entry or participation
  • Clinically significant major organ disease
  • Female subjects of childbearing potential not practicing adequate birth control
  • Subjects with COPD: Significant improvement in pre-to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC or FEV1);
  • Any clinically important pulmonary disease except mild or moderate COPD
  • Subjects without COPD: Any important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings
  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: NCT01021891

Locations
United States, Texas
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, United States, 78229
Austria
Medical University Graz
Graz, Austria, A-8036
Netherlands
University Medical Centre Groningen
Zuidlaren, Netherlands, 9470 AE
United Kingdom
Medicines Evaluation Unit (MEU)
Manchester, England, United Kingdom, M23 9QZ
ICON Development Solutions
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Chair: Anders Boss, MD MannKind Corp
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT01021891     History of Changes
Other Study ID Numbers: MKC-TI-015, EudraCT Number: 2007-002818-19
Study First Received: November 25, 2009
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mannkind Corporation:
Technosphere® Insulin Inhalation Powder

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014