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

Completed · Phase 1

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01544881

Run by

Mannkind Corporation

People needed

17

Starts

2012-03-01

Expected to finish

2013-01-01

Last updated by the study team

2013-01-25

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Profil Institute for Clinical Research — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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