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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01021891
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : December 17, 2013
Information provided by (Responsible Party):
Mannkind Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Technosphere®/Insulin Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : July 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01021891

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United States, Texas
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, United States, 78229
Medical University Graz
Graz, Austria, A-8036
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
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Study Chair: Anders Boss, MD MannKind Corp

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Responsible Party: Mannkind Corporation Identifier: NCT01021891     History of Changes
Other Study ID Numbers: MKC-TI-015
EudraCT Number: 2007-002818-19
First Posted: November 30, 2009    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013
Keywords provided by Mannkind Corporation:
Technosphere® Insulin Inhalation Powder
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs