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

NCT00995540 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-02-12

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

INGAP Peptide

100 mg INGAP Peptide tid subcutaneous injection for 12 weeks

DRUG

INGAP Peptide

200 mg INGAP Peptide tid subcutaneous injection for 12 weeks

DRUG

Placebo

Placebo tid subcutaneous injection for 12 weeks

Sponsors & Collaborators

  • Exsulin Corporation

    lead INDUSTRY

Principal Investigators

  • Yogish Kudva, M.D. · Mayo Clinic

  • George Tsoukas, MD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995540 on ClinicalTrials.gov