Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes

Summary

Primary Objective: To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative phase). Secondary Objective: To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman To evaluate daily insulin doses To assess Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases

Timeline

Start

2010-11-16

Primary completion

2018-02-01

Completion

2018-02-01

Outcome

Met primary endpoint

paper Noninferiority of Insuman versus Insuplant was demonstrated both for the HbA1c change from baseline (as a percentage) PMID 24735100 ↗

Publications

• Schaepelynck P, Riveline JP, Renard E, Hanaire H, Guerci B, Baillot-Rudoni S, Sola-Gazagnes A, Catargi B, Fontaine P, Millot L, Martin JF, Tachouaft H, Jeandidier N; EVADIAC Group. Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. Diabetes Technol Ther. 2014 Sep;16(9):582-9. doi: 10.1089/dia.2013.0369. Epub 2014 Apr 15.

Drugs

Indications