To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419302
• Other study ID #: MKC-TI-03B
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2007
• Last updated: October 12, 2009
• Start date: October 2003
• Est. completion date: April 2004

Study information

• Verified date: October 2009
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial was designed to compare meal related inhalation of Technosphere/Insulin to subcutaneous regular insulin in patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of type 2 diabetes mellitus.

• Current regimen of intensified insulin therapy for at least 6 months.

• Body Mass Index less than 35 kg/m2.

• HbA1c less than or equal to 9%.

• Non-smoker for at least 2 years.

• If medications in addition to insulin are taken at screening, the patient must be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least three months.

• Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), forced mid-expiratory flow rate 25 %-75 % (FEF25-75), slow vital capacity (SVC) as measured by spirometry, and single-breath carbon monoxide diffusing capacity corrected for hemoglobin and carboxyhemoglobin (DLco), all greater than or equal to 80 % of expected normal.

• Ability to perform PFT, without coughing within the first 5 seconds of test.

• Written informed consent.

Exclusion Criteria:

• Diabetes mellitus type 1.

• Current treatment (within the last 30 days) with oral antidiabetic agents.

• Regular pre-prandial doses of regular insulin of more than 30 IU.

• Intake of any drug or herbal preparation which, in the evaluation of the investigator, may interfere with the interpretation of trial results or that is known to cause clinically relevant interference with insulin action, glucose utilization or recovery from hypoglycemia (e.g. systemic steroids).

• History of hypersensitivity to the study drug or to drugs with similar chemical structures.

• Treatment with any other investigational drug within three months prior to enrollment in study.

• Progressive fatal disease.

• History of malignancy within five years of study entry (other than basal cell epithelioma).

• History of drug or alcohol abuse.

• Evidence of severe secondary complications of diabetes (neuropathy, nephropathy as evidence by creatinine > 1.5 for females or > 1.8 for males, retinopathy, or severe peripheral vascular disease).

• Evidence of gastroparesis, orthostatic hypotension or hypoglycemia unawareness (autonomic neuropathy).

• Myocardial infarction or stroke within the preceding six months.

• Positive hepatitis B (hepatitis B surface antigen) and/or hepatitis C (hepatitis C antibody) serology and/or positive HIV serology.

• History or presence of clinically significant cardiovascular, hepatic (as evidenced by ALT or AST > 3 times the normal reference range), gastrointestinal, neurological or infectious disorders capable of altering the absorption, metabolism or elimination of drugs, or constituting a risk factor when taking the study medication.

• Anemia (hemoglobin levels less than 11 g/dL for females or 12 g/dL for males).

• Ongoing respiratory tract infection.

• Pregnancy, lactation, or intention to become pregnant.

• Sexually active women of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermacide, intrauterine devices, or surgical sterilization).

• Regular alcohol intake greater than 14 units*/week, or subjects unwilling to stop alcohol for the duration of the study (* 1 unit = 8 g ethanol, 1/4 liter of beer or 1 glass wine or 1 measure of spirits).

• Investigator or site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.

• A lack of compliance (including the inability to maintain a minimum of 75 % compliance with study drug administration) or other reasons, which in the opinion of the Investigator preclude the participation of the subject in the study.

• Prior diagnosis of idiopathic pulmonary fibrosis, asbestosis, silicosis, sarcoidosis, histiocytosis X (Langerhans cells histiocytosis), farmer's lung, Wegener's granulomatosis, pneumoconiosis (coal miner's lung), desquamative interstitial pneumonia, alveolar proteinosis, Goodpasture's syndrome, bronchiolitis obliterans organizing pneumonia (BOOP), hypersensitivity pneumonitis, lymphangioleiomyomatosis, amyloidosis, lymphocytic interstitial pneumonitis, Churg-Strauss syndrome (allergic granulomatosis and angiitis).

• Current or chronic infection with tuberculosis, cytomegalovirus, aspergillus, blastomyces, cryptococcus, histoplasma, coccidioides, pneumocystis carinii, mycobacterium avium intracellulare, pseudomonas, actinomyces, nodcardia, mucor, candida.

• Prior diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine.

• History of chronic obstructive pulmonary disease, reactive airway disease, bronchiectasis, bronchiolitis obliterans, chronic bronchitis, emphysema or asthma requiring hospitalization and/or chronic treatment with supplemental oxygen or inhaled or systemic beta adrenoreceptor agonists, steroids or corticosteroids.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Technosphere/Insulin

Locations

Country	Name	City	State
Germany	Profil Institute for Metabolic Research	Hellersbergstr

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic response to a meal challenge
Secondary	Serum insulin concentrations measured for Technosphere/Insulin administration and subcutaneous insulin administration across 13 time points over a 270 minute period
Secondary	Safety variables