drugset / Trial / NCT00594152

Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)

NCT00594152 ↗

Phase 3 Completed 71 enrolled Joslin Diabetes Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Investigators with the goal of optimizing glycemic and blood pressure control saw type 1 diabetic patients weekly. A control group received 3-4 subcutaneous insulin injections per day; an intravenous insulin pulsed infusion group received, in addition, three one hour infusions in a pulsatile fashion over one eight hour period each week. Patients were followed for 12 months with periodic testing of renal function by repeated blood and urinary analyses; diabetes control by blood testing and diabetes impact measurement score; cardiac and autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual changes with repeated fundus photography. The study hypothesis was that correction of respiratory quotient would correct the defect leading to microvascular complications of diabetes (Type 1).

Timeline

Start
1993-01
Primary completion
—
Completion
1995-01

Outcome

Mixed primary results

paper Statistically significant preservation of renal function by pulsatile insulin infusion PMID 20189608 ↗

paper was not matched by a statistically significant prevention of DR progression compared with standard diabetes care. PMID 20189608 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic — Intravenous