drugset / Trial / NCT00995540

Tolerability, Safety, and Efficacy Study of INGAP Peptide to Treat Type 1 Diabetes Mellitus in Adults

NCT00995540

Phase 2 Terminated 23 enrolled Exsulin Corporation
RandomizedParallel-groupTriple-blindTreatment

Summary

INGAP Peptide acetate is the active ingredient of INGAP Peptide Solution for Injection. It is being developed as an antidiabetic agent for the restoration of endogenous insulin secretion in patients with type 1 diabetes mellitus (T1DM) and in insulin-deficient patients with type 2 diabetes mellitus (T2DM). This clinical study is designed to generate additional data regarding the appropriate dose and dosing regimen and to evaluate safety and efficacy in patients with T1DM.

Timeline

Start
2009-11
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator INGAP Peptide Peptide 100 mg Subcutaneous
Comparator INGAP Peptide Peptide 200 mg Subcutaneous