A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00570687
First received: December 7, 2007
Last updated: October 23, 2009
Last verified: October 2009
  Purpose

Twelve Type 2 diabetic subjects will each receive 2 different insulin medicinal products prior to a meal test and then, following an interim safety visit, receive the same 2 doses of insulin in the same order during a glucose clamp procedure.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Technosphere Insulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • To assess endogenous glucose production (EGP) [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Technosphere Insulin
Drug: Technosphere Insulin
Inhalation 15U/30U

Detailed Description:

This is a randomized, open label, 2-way cross-over study with 7 visits for each completed subject. The visits comprise an initial screening visit, 2 treatment visits for the meal challenge followed by a 2-6-week blood-loss recovery period, an interim safety visit, 2 sequential visits for the glucose clamp, and a final close-out visit. Each treatment visit, meal challenge and glucose clamp, will have the subjects hospitalized in the clinical unit the night before initiation of treatment.

  Eligibility

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

Inclusion Criteria:

  • Receiving diabetes treatment with insulin for a minimum of 3 months
  • Body Mass Index (BMI) of = 34 kg/m2 and = 25 kg/m2
  • HbA1c = of 8.5% based upon results from a central laboratory
  • Non-smoking Males and females = 18 and = 70 years of age
  • A clinical diagnosis of type 2 diabetes mellitus for = 12 months

Exclusion Criteria:

  • Total daily insulin requirement of = 1.2 U/kg body weight
  • Use of Symlin® (pramlintide acetate) and/or Byetta® (exenatide) within the preceding 8 weeks
  • Two or more severe hypoglycemic episodes within 6 months of screening
  • Any hospitalization or emergency room visit due to poor diabetic control within 6 months of Screening
  • Severe complications of diabetes
  • Previous exposure to any inhaled insulin product
  • Currently using an insulin delivery pump
  • Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial
  • Any clinically important pulmonary disease, confirmed by documented history, pulmonary function testing, or radiologic findings
  • Chronic use of systemic steroids
  • Inability to perform PFT maneuvers to meet the recommended American Thoracic Society (ATS) standards of acceptability and repeatability
  • Significant improvement in spirometry following bronchodilation
  • Active respiratory infection
  • Seizure disorder
  • Significant cardiovascular dysfunction and/or history within 3 months of Screening
  • Uncontrolled hypertension with a systolic blood pressure of >160 mm Hg and/or diastolic blood pressure > 95 mm Hg at screening, despite pharmacologic treatment
  • Clinical nephrotic syndrome or renal dysfunction or disease
  • Cancer (other than an excised cutaneous basal cell carcinoma) within the past 5 years or any history of lung neoplasms
  • History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes
  • Active infection eg, Human Immunodeficiency Virus (HIV), Hepatitis, or history of severe infection within 30 days of Screening
  • Anemia
  • A previous diagnosis of systemic autoimmune or collagen vascular disease requiring prior or current treatment with systemic corticosteroids, cytotoxic drugs or penicillamine
  • Any concurrent illness, other than diabetes mellitus not controlled by a stable therapeutic regime
  • Current or previous chemotherapy or radiation therapy that may result in pulmonary toxicity
  • Clinically significant abnormalities on screening laboratory evaluation
  • Female subjects who are pregnant, lactating or planning to become pregnant during the clinical trial period
  • Female subjects of childbearing potential (defined as pre-menopausal and not surgically sterilized or post-menopausal for less than 2 years) not practicing adequate birth control.
  • Current drug or alcohol abuse, or a history of drug or alcohol abuse, that, in the opinion of the PI, would not make the subject a suitable candidate for participation in the clinical trial
  • Exposure to any investigational medications or devices within the previous 30 days prior to trial entry or participation in another clinical trial during this trial
  • Unable and/or unlikely to comprehend and/or follow the trial protocol
  • Concurrent medical or major psychiatric condition which, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570687

Locations
Germany
Profil Institute for Metabolic Research
Neuss, GER, Germany
Sponsors and Collaborators
Mannkind Corporation
Investigators
Principal Investigator: Klaus Rave, MD Profil Institute for Metabolic Research
  More Information

No publications provided

Responsible Party: Robert Baughman, MannKind Corporation
ClinicalTrials.gov Identifier: NCT00570687     History of Changes
Other Study ID Numbers: MKC-TI-118
Study First Received: December 7, 2007
Last Updated: October 23, 2009
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Mannkind Corporation:
Inhaled Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014