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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 belowIDIDM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months
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 moreIDIDM 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.
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