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

NCT00837759 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2013-01-03

Study results available
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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.

Conditions

  • Diabetes Mellitus Type 1
  • Autoimmune Diabetes

Interventions

DRUG

Insulin

DRUG

Lansoprazole

DRUG

Sitagliptin

BIOLOGICAL

Diamyd

DRUG

GAD65 (Diamyd)

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Balow James, MD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

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 NCT00837759 on ClinicalTrials.gov