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A multiple-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of INGAP in patients with Type 1 diabetes mellitus.

IRB Number:

09-003519

Trial status:

Open for Enrollment

Phase: II

Why is this study being done?

We are conducting a research study to learn about the safety and efficacy of a drug for the treatment of diabetes. This study will help us to understand the effects from this drug and will help develop a new therapy for type 1 diabetes. This drug which is called INGAP enhances the regeneration of insulin producing cells in the body.

Who is eligible to participate?

Using insulin pump therapy or multiple daily insulin injections.

Have a history of diabetes for more than 2 but less than 20 years.

Willing to use subcutaneous injections of the new drug.

What is involved?

Regular visits to Mayo Clinic - Rochester every two weeks for the total of nine visits. Five of these are about three hours long and the rest of them about 1-2 hours long. The visits involve interviews and blood draws to assess the tolerability and effectiveness of the new drug.
During this study, you will receive a medication that needs injections very similar to the insulin injections for the duration of 12 weeks.

How long is the study?

19 weeks (about 5 months)

Who can I contact for additional information?

Dr. Nassir Rostambeigi at 507) 284-4757; pager 127-06578;
or email rostambeigi.nassir@mayo.edu

Where is the trial located?

  • Rochester, MN

Last updated: 12/11/2009