Clinical Trial Information
Principal Investigator - Nayyar Iqbal, MD
Title: A phase 3, open-label, parallel-group study to evaluate the efficacy of preprandial human insulin inhalation powder (HIIP) compared to preprandial injectable insulin in patients with type 1 diabetes mellitus
Purpose: This is a randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6-month study with approximately 320 patients that will assess the efficacy of HIIP in patients with type 1 diabetes. The University of Pennsylvania is expected to enroll a minimum of 6 subjects.
Brief Description: This study is designed to establish the efficacy and safety of HIIP for the treatment of type 1 diabetes. It involves a comparison of the efficacy and safety of HIIP and insulin lispro administered preprandially in combination with insulin glargine.
Following informed consent and baseline information collection, there will be a lead-in period with preprandial insulin lispro and insulin glargine to optimize daily insulin treatment. Patients will then be randomized to one of two groups (preprandial HIIP plus insulin glargine or preprandial injectable insulin plus insulin glargine) in a 1:1 ratio for a total of 7 visits over 6-7 months including screening/lead in and follow up.
The study is sponsored by the Eli Lilly Company.
Eligibility:
One can take part in this study if he/she has:
- Type 1 diabetes (for at least 24 months).
- Is taking at least 2 to 3 insulin injections per day (for at least 2 months).
- Is at least 18 years old.
One cannot take part in this study if he/she has:
- Smoked in the 6 months prior to this study, or think you will be smoking at any time during this study.
- A requirement of more than 150 units per day of insulin.
- Recent severe low blood sugar episodes or significant blood sugar control problems.
- Certain lung problems such as recent pneumonia, lung cancer or lung transplantation, asthma, chronic obstructive pulmonary disease (COPD), or other significant lung diseases.
- Certain liver or kidney problems.
- Angina (chest pain), a myocardial infarction (heart attack), or other serious heart disease within the 6 months prior to study entry.
- Active or untreated cancer, or have been in remission from cancer for less than 5 years, exceptions to this are minor skin cancers, and localized cervical or prostate cancer.
- Received some types of glucocorticoid therapy.
- Received any treatment within the last 30 days with a drug that is not yet available commercially for any medical reason (it is still a research drug).
Compensation: Volunteers will be paid $50.00 per visit (7 visits) for their participation in this study in two separate installments; at three months and upon completion of the study. If volunteer withdraws from the study early, volunteer will be paid for the portion of the study that was completed.
Contact Info:
Name: Cornelia V. Bakes (Ginger)
Phone: 215-823-5961
Email: cornelia.bakes@va.gov
