drugset
drugset / Trial / NCT00211536

Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration

NCT00211536 ↗

Phase 3 Completed 107 enrolled Medtronic MiniMed, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.

Timeline

Start
2002-06
Primary completion
2004-08
Completion
2008-09

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); MiniMed Implantable Insulin Pump (MIP) vs Subcutaneous Insulin Arm (SC); p <0.05; Least square means 0.3; Mixed Models Analysis NCT00211536 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aventis HOE21PH U400 Protein / enzyme biologic — Intrathecal
Subject Medtronic MiniMed Implantable Pump Human Recombinant Insulin Unknown — Intrathecal

Indications

type 1 diabetes mellitus