Bioavailability of Technosphere® Insulin Versus Subcutaneous Regular Human Insulin in Type 2 Diabetes

NCT00511719 | Completed Phase 2

• 1 other identifier: MKC-TI-003b2
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the kinetics and biodynamics of inhaled Technosphere Insulin with those of subcutaneous (SC) regular human insulin.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Dose-corrected area-under-the serum insulin concentration vs. time curve (AUC0-540 min) for inhaled Technosphere® Insulin compared to that of subcutaneous regular human insulin

  crossover approx every 2 weeks for up to 10 weeks

• Area under the glucose infusion rate (GIR AUC0-540 min) for Technosphere® Insulin compared to regular human insulin

  crossover approx every 2 weeks for up to 10 weeks

• Intra-patient and inter-patient comparison of CV % between treatments was based on a t-test.for bioavailability (ie, SI AUC0-540 min) & bioeffect (ie, GIR AUC0-540 min)

  crossover approx every 2 weeks for up to 10 weeks

Secondary Outcomes (2)

• Safety variables included adverse events, HbA1c, pulmonary function tests, and diabetes-specific signs (ie, hypoglycemia and hyperglycemia)

  crossover approx every 2 weeks for up to 10 weeks

• Safety variables included adverse events (AEs), clinical laboratory tests, HbA1c, pulmonary function tests, electrocardiograms, vital signs, physical examinations, and diabetes-specific signs

  crossover approx every 2 weeks for up to 10 weeks

Study Arms (2)

Technosphere Insulin

EXPERIMENTAL

Technosphere Insulin Inhalation Powder

Drug: Technosphere Insulin

Actrapid

ACTIVE COMPARATOR

Subcutaneous regular human insulin

Drug: Actrapid

Interventions

Technosphere Insulin DRUG

48U

Technosphere Insulin

Actrapid DRUG

24IU

Actrapid

Eligibility Criteria

• Age: 18 Years - 65 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 (defined as separate injections of basal and prandial insulin with at least three injections per day) for at least six months prior to the study, including the use of long-lasting insulin analogue glargine (Lantus)
• Patients must have been willing to withhold insulin glargine for 24 hours prior to study drug dosing
• to 65 years old
• Body Mass Index \<35kg/m2
• HbA1c\<9%
• Non-smoker for at least 2 years
• If medications (other than oral anti-diabetic agents) in addition to insulin were taken at screening, the patient had to be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least 3 months immediately prior to study enrollment
• FVC, FEV1, and VC all \>80% of expected normal
• Written informed consent

You may not qualify if:

• Diabetes mellitus type 1
• Current treatment (within the last 30 days) with oral anti-diabetic agents
• Regular pre-prandial doses of regular subcutaneous insulin for more than 30 IU per meal
• Intake of any drug or herbal preparation that, in the evaluation of the investigator, may interfere with the interpretation of clinical trials results or that is known to cause clinically relevant interference with insulin action, glucose utilization or recovery from hypoglycemia (eg, systematic steroid)
• HIstory of hypersensitivity to the drug or to drugs with similar chemical structures
• Treatment with any investigation drug within 3 months prior to enrollment or during this study
• Progressive fatal disease
• History of malignancy within 5 years of study entry (other than basal cell carcinoma)
• History of drug or alcohol abuse
• Evidence of severe secondary complications of diabetes (neuropathy, nephropathy as evidenced by creatinine \>1.5 mg/dL for females or \>1.8 mg/dL for males, grade III or IV retinopathy, or severe peripheral vascular disease)
• Evidence of gastroparesis, orthostatic hypotension or hypoglycemia unawareness (autonomic neuropathy)
• Myocardial infraction 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 of 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 significant risk factor when taking the study medications
• Anemia (hemoglobin concentrations \<11 g/dL for females of \<g/dL for males)

Sponsors & Collaborators

• Mannkind Corporation: lead

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 Design

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

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 6, 2007
• Study Start: February 1, 2004
• Primary Completion: April 1, 2004
• Study Completion: March 1, 2005
• Last Updated: June 29, 2011

Record last verified: 2011-06