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

NCT00419302 | Completed Phase 2

• 1 other identifier: MKC-TI-03B
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glycemic response to a meal challenge

Secondary Outcomes (2)

• Serum insulin concentrations measured for Technosphere/Insulin administration and subcutaneous insulin administration across 13 time points over a 270 minute period

• Safety variables

Interventions

Technosphere/Insulin DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

Profil Institute for Metabolic Research

Hellersbergstr, D-41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Klaus Rave

  Profil Institute for Metabolic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 4, 2007
• First Posted: January 8, 2007
• Study Start: October 1, 2003
• Study Completion: April 1, 2004
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

DE (1)