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Immunomodulator

IVIg--Washout--0.9% NaCl (CROSSOVER) for Diabetes (IDIDM Trial)

Phase 4
Waitlist Available
Led By Ari Breiner, MD, FRCPC
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years.
Diabetes, as per American Diabetes Association Criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months
Awards & highlights

IDIDM Trial Summary

The purpose of this study is to determine whether intravenous immunoglobulin (IVIg) is an effective intervention for patients with diabetes, peripheral neuropathy, and demyelination on nerve conduction studies. All patients will receive both IVIg and placebo for 3 months each, with a 3 month washout period in between.

Eligible Conditions
  • Diabetes
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Peripheral Neuropathy

IDIDM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

IDIDM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Overall Neuropathy Limitations Score (ONLS) after 3 months
Secondary outcome measures
Adverse Events
Change in Grip Strength after 3 months
Change in Medical Research Council (MRC) Sum Score after 3 months
+3 more

IDIDM Trial Design

2Treatment groups
Experimental Treatment
Group I: IVIg--Washout--0.9% NaCl (CROSSOVER)Experimental Treatment2 Interventions
10% caprylate-chromatography purified intravenous immunoglobulin (IVIg) Initial dose: 1.0gm/kg/day for 2 days (maximum 80gm/day). Maintenance dose (monthly x3): 1.0mg/kg/day for 1 day (maximum 80gm/day) Washout period 0.9% sodium chloride in water - equal volume to IVIg - Monthly x4
Group II: 0.9% NaCl--Washout--IVIg (CROSSOVER)Experimental Treatment2 Interventions
0.9% sodium chloride in water - equal volume to IVIg - Monthly x4 Washout period 10% caprylate-chromatography purified intravenous immunoglobulin (IVIg) Initial dose: 1.0gm/kg/day for 2 days (maximum 80gm/day). Maintenance dose (monthly x3): 1.0mg/kg/day for 1 day (maximum 80gm/day)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium chloride
FDA approved

Find a Location

Who is running the clinical trial?

University Health Network, TorontoOTHER
1,456 Previous Clinical Trials
482,774 Total Patients Enrolled
10 Trials studying Diabetes
2,688 Patients Enrolled for Diabetes
University of TorontoLead Sponsor
687 Previous Clinical Trials
1,018,270 Total Patients Enrolled
33 Trials studying Diabetes
3,831 Patients Enrolled for Diabetes
Ari Breiner, MD, FRCPCPrincipal InvestigatorUniversity of Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025