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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01194882
First received: September 2, 2010
Last updated: July 28, 2014
Last verified: July 2014

September 2, 2010
July 28, 2014
November 2010
December 2014   (final data collection date for primary outcome measure)
  • Refill accuracy between the 2 insulin groups [ Time Frame: During 4 refill cycles ] [ Designated as safety issue: No ]
  • Change in glycosylated hemoglobin (HbA1c) [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01194882 on ClinicalTrials.gov Archive Site
  • Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
  • Occurrence of hyperglycaemia [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
  • Occurrence of diabetic ketoacidosis [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in insulin dose [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
  • Antibody assessments (anti-Insulin antibodies) [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
Evaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml

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

The study duration will be displayed in 2 parts as follow:

Comparative phase (only French patients): 160 +/- 20 days Open label Insuman Implantable extension phase (French and European patients): from day 160 up to the grant of Insuman implantable marketing authorization

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: HUMAN INSULIN (BIOSYNTHETIC)
    Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml
    Other Name: HR1799
  • Drug: Insuplant

    Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use

    Dose regimen:

    Other Name: Human insulin semi synthetic porcine derived
  • Experimental: Insuman Implantable
    Starting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines.
    Intervention: Drug: HUMAN INSULIN (BIOSYNTHETIC)
  • Active Comparator: Insuplant
    Starting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines.
    Intervention: Drug: Insuplant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
458
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Patients already treated with Insuplant 400 IU/ml via a Medtronic Implantable System 2007
  2. Glycosylated hemoglobin ≤9.0%
  3. Patient showing a percentage of error at refill equal or below 20%
  4. Patient undergoing NaOH rinse procedure of at least 10 minutes period with or without flush Or Patient being re-implanted with a new pump (first fill with insulin)
  5. Signed informed consent form prior to enrolment

Exclusion criteria:

  1. Pump life time > 6 years
  2. Pump battery voltage < 2.6 volts
  3. Pregnancy or childbearing potential without a medically approved form of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Netherlands,   Sweden
 
NCT01194882
HUBIN_L_05335, 2010-021373-37, U1111-1116-7658
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP