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safety

A study to evaluate a new Exsulin formulation and treatment regimen is slated to begin in June 2009.

Phase II: Study E-201

A Multiple-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Tolerability, Safety, and Efficacy of a New Formulation of INGAP Peptide Given Subcutaneously as Injections t.i.d. for 12 Weeks in Adult Patients with Type 1 Diabetes Mellitus.

Objectives:

The objectives of the study will be to assess the safety and tolerability of 12 weeks of three times a day subcutaneous (SC) injections of INGAP peptide. Secondary objectives of this study are to compare efficacy of SC injections of INGAP Peptide compared to placebo as measured by C-peptide, fasting glucagon, fasting glucose, total daily insulin dose, and HbA1c.

Populations to be studied:

Mayo Clinic in Rochester, MN and McGill University Hospital Centre, Montreal Canada are currently enrolling patients in the first and only Phase II clinical trial targeted at regeneration of insulin-producing islets in patients with established Type 1 Diabetes. If you have had Type 1 diabetes for more than 2 years, are between the ages of 19-60, have maintained good control of your diabetes, and know your HbA1c and your fasting C-peptide level, you may qualify to participate in this trial. Contact Mayo Clinic or McGill University Hospital Centre for more information. Patients willing to participate after they have been informed about the study and its conduct and signed an informed consent form may be considered and screened for eligibility according to the complete inclusion/exclusion criteria.

Clinical
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Underway

Planned Trials Underway