title: Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes.
abstract: BACKGROUND
  Implanted insulin pumps using the peritoneal route provide long-term improvement of glucose control compared with subcutaneous insulin therapy in type 1 diabetes (T1D) patients. The stability of insulin preparation is critical for a safe use in implanted pumps. Insuman implantable(®) (400 IU/mL) (Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany), a recombinant human insulin, has been developed as a replacement for Insuplant(®) (Aventis Pharma, Frankfurt am Main, Germany), a semisynthetic insulin, the only one used so far. The aim of the study was to demonstrate the noninferiority of Insuman versus Insuplant, in terms of safety and effectiveness when used in implanted pumps.
  
  
  METHODS
  The patients enrolled, currently treated for T1D by the Medtronic MiniMed (Northridge, CA) implantable pump model 2007 with Insuplant, were randomized into two study arms and received either Insuman or Insuplant for four pump refill cycles. Each pump refill cycle was 40±5 days. The co-primary end points included glycated hemoglobin (HbA1c) change from baseline and pump infusion accuracy.
  
  
  RESULTS
  In total, 169 patients were randomized. Noninferiority of Insuman versus Insuplant was demonstrated both for the HbA1c change from baseline (as a percentage) with intergroup difference of 95% confidence interval (-0.36;+0.11) and for the infusion accuracy assessed by the measured percentage of error at pump refill, as shown by intergroup difference of 95% confidence interval (-5.81; -0.50), in per-protocol populations, although the insulin daily dose was similar. Severe hypoglycemia occurred at least once in 12 versus 11 patients, respectively, and metabolic or technical adverse events were comparable.
  
  
  CONCLUSIONS
  Findings suggest that Insuman can safely and effectively replace Insuplant in implanted pumps.
authors.affiliation: 1 Department of Nutrition-Endocrinology-Metabolic Disorders, Marseille University Hospital , Sainte Marguerite Hospital, Marseille, France .
authors.forename: Pauline
authors.initials: P
authors.lastname: Schaepelynck
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Riveline
authors.forename: Eric
authors.initials: E
authors.lastname: Renard
authors.forename: Hélène
authors.initials: H
authors.lastname: Hanaire
authors.forename: Bruno
authors.initials: B
authors.lastname: Guerci
authors.forename: Sabine
authors.initials: S
authors.lastname: Baillot-Rudoni
authors.forename: Agnès
authors.initials: A
authors.lastname: Sola-Gazagnes
authors.forename: Bogdan
authors.initials: B
authors.lastname: Catargi
authors.forename: Pierre
authors.initials: P
authors.lastname: Fontaine
authors.forename: Luc
authors.initials: L
authors.lastname: Millot
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Martin
authors.forename: Hocine
authors.initials: H
authors.lastname: Tachouaft
authors.forename: Nathalie
authors.initials: N
authors.lastname: Jeandidier
mesh_terms: D001786:Blood Glucose / Q000187:drug effects*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D015918:Infusion Pumps, Implantable; D007263:Infusions, Parenteral; D007328:Insulin / Q000008:administration & dosage* / Q000031:analogs & derivatives; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human