Clinical Trial Information
Principal Investigator - Nayyar Iqbal, MD
Title: A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients with Type 2 Diabetes Treated with Once-Daily Insulin Glargine.
Purpose: This is a multi-site, randomized, open-label, active-comparator, three-arm, parallel study designed to establish the efficacy and safety of HIIP for the treatment of type 2 diabetes as compared with insulin glargine.
Brief Description: Approximately 510 male and female patients with type 2 diabetes taking once-daily insulin Glargene will participate. The University of Pennsylvania is expected to enroll a minimum of 6 subjects.
The trial is sponsored by The Eli Lilly Company
Eligibility:
One can take part in this study if he/she has:
- Type 2 diabetes (for at least 6 months).
- Is taking 1 or more types of oral anti-diabetes medications (blood sugar pills). The dose (amount) of these pills should not have changed for the last 6 weeks, except for one type of medication called thiazolidinedione (TZD), such as Actos and Avandia, which should not have changed for at least the last 3 months.
- Must also have been taking once-daily insulin glargine (a long-acting insulin injection) for at least 4 months.
One cannot take part in this study if he/she has:
- More than 2 episodes of very low blood sugar OR had to visit a hospital for poor blood sugar control, during the past 6 months.
- Smoked in the 6 months prior to this study, or thinks he/she will be smoking at any time during this study.
- 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 has been in remission from cancer for less than 5 years (exceptions to this are minor skin cancers, and localized cervical or prostate cancer).
- Certain lung problems such as recent pneumonia, lung cancer, lung transplantation, asthma, or chronic obstructive pulmonary disease (COPD).
- 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). Patient may not have completed or withdrawn from any study investigating inhaled insulin where he/she took one or more doses of inhaled insulin.
- Taken exenatide (Byetta™) within 6 weeks (this is an injection medication for type 2 diabetes).
- A requirement of more than 150 units per day of insulin glargine.
Compensation: Volunteers will be paid $50.00 per visit 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, he/she will be paid for the portion of the study that was completed.
Contact Info:
Name: Jessica Liu
Phone: 215-823-5961
Email: jessica.liu2@va.gov
