drugset / Trial / NCT00837759

Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes

NCT00837759

NaSingle-groupOpen-labelTreatment

Summary

Background: * Type 1 diabetes (T1D) occurs when the immune system attacks insulin-producing cells (beta cells) in the pancreas, resulting in their death. * Insulin injections currently are the best method for controlling blood sugar in individuals with T1D. However, animal studies have shown that the drugs sitagliptin and lansoprazole can help reverse beta cell damage or develop new beta cells. In addition, Diamyd has been shown to weaken the immune process that attacks pancreatic beta cells. Objectives: * To find out whether a combination treatment of sitagliptin, lansoprazole, and Diamyd will help maintain functioning beta cells and/or cause new beta cells to form. * To determine how the drug combination affects insulin doses and blood sugar control. * To determine whether the drug combination affects the immune response involved in T1D.

Timeline

Start
2009-02
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject GLUTAMATE DECARBOXYLASE 2 Vaccine
Subject Lansoprazole Other / unclassified
Subject Sitagliptin Small molecule
Background Insulin Protein / enzyme biologic