Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Men and women aged 18 to 60 years

• One of more daily sc insulin injections of any insulin type or insulin pump use

• Body mass index (BMI) = 30 kg/m2

• Pulmonary function tests (PFTs) conducted at Visit 1:

• FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted

• FVC ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted

• Diagnosis of type 1 diabetes for at least 12 months

• Good venous access for blood draws

• Written informed consent provided

• No smoking in the previous 6 months (including cigarette, cigars, pipes) and negative urine cotinine testing (<100 ng/mL)

• C-peptide < 0.3 ng/mL

• Hemoglobin A1c (HbA1c) = 10.0%

Exclusion Criteria:

• Total daily insulin requirement of = 1.4 U/kg body weight

• Serum creatinine = 2.0 mg/dL in men and > 1.8 mg/dL in women

• Blood donation of 500 mL within the previous 56 days

• Current treatment with pramlintide acetate or exenatide

• Unstable diabetes control and evidence of severe complications of diabetes (ie, autonomic neuropathy)

• History of chronic obstructive pulmonary disease (COPD) or asthma, or any other clinically important pulmonary disease confirmed by pulmonary function testing or radiologic findings

• Upper respiratory tract infection within 8 weeks before screening

• History of coronary artery disease, peripheral vascular disease, or congestive heart failure

• Allergy to study drug, food, or other study material (eg, peanuts, soy products)

• Clinically significant active or chronic illness

• History of drug or alcohol abuse

• Positive urine drug screen

• Clinically significant screening ECG, physical examination, laboratory test, or vital sign abnormality

• Exposure to any other investigational drug or device within 30 days before treatment or within 90 days before treatment for drugs known to modify glucose metabolism (except metformin)

• History of malignancy within the 5 years before screening (other than basal cell carcinoma)

• History of human immunodeficiency virus (HIV) infection or hepatitis B or C

• Women who are pregnant, lactating, or planning to become pregnant during the clinical study period

• Women of childbearing potential (defined as premenopausal and not surgically sterilized or postmenopausal for fewer than 2 years) not practicing adequate birth control. Adequate birth control is defined as using oral, percutaneous, or transdermal contraceptives; condoms and diaphragms (double barrier) with a spermicide; or intrauterine devices. Postmenopausal for the purposes of this clinical study includes experiencing amenorrhea for 2 or more years or being surgically sterile

• Inability, in the opinion of the PI or a designee, to adequately inhale TI Inhalation Powder

• Any subject who, in the opinion of the PI or a designee, appears to not be qualified for this study