Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Insulin-Dependent

In brief

Insulin is a chemical that the body needs in order to use or store sugar. It is made by a type of cell called a beta cell which resides in an organ known as the pancreas. Type 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new beta cells in the pancreas, and to restore the ability to produce insulin in type 1 diabetic patients.

Key facts

Study ID

NCT00071409

Run by

Exsulin Corporation

People needed

63

Starts

2003-10-01

Expected to finish

2004-05-01

Last updated by the study team

2014-07-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65
• fasting C-peptide <0.3 ng/ml.
• HbA1c <10%
• history of onset of type 1 DM at or before 20 years of age.
• Otherwise healthy

Where it is running

• Radiant Research — Irvine, California, United States
• VA Hospital UCSD — San Diego, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• MedStar Clinical Research Center — Washington D.C., District of Columbia, United States
• Springfield Diabetes and Endocrine Center — Springfield, Illinois, United States
• Mercury Street Medical — Butte, Montana, United States
• UNC Diabetes Care Center — Durham, North Carolina, United States
• Clinical Research Institute of Southern Oregon — Medford, Oregon, United States
• University of Texas Health Science Center - Texas Diabetes Institute — San Antonio, Texas, United States
• DGD Research Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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