Trial intelligence / Profile preview

CIIIT in Type 1 Diabetic Nephropathy

NCT00594152Phase 3

Key facts

Status: Completed
Start: Jan 1993
Countries: 1
Sponsor: Joslin Diabetes Center
Modality: Recombinant Proteins and Enzymes

Drugs: regular human insulin
Conditions: diabetic nephropathy (DN)diabetic retinopathy (DR)

Overview

Phase 3, randomised, open-label trial of regular human insulin in diabetic nephropathy (DN) and diabetic retinopathy (DR) (2 arms), sponsored by Joslin Diabetes Center. Primary endpoint: Rate of loss of creatinine clearance at 18 months. Started Jan 1993; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Control
Standard SC Insulin (3-4 injections/day)
Treatment
Standard SC Insulin + Weekly CIIIT (3x 1hr IV pulses)

Endpoints

Primary

Rate of loss of creatinine clearance18 months

Secondary

Quality of life assessment12 to 18 months
Change in cardiac autonomic function12 to 18 months
Change in retinal photos12 to 18 months
Change in cardiac function12 to 18 months

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