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

ID: NCT01194882
Status: Completed
Phase: Phase 3
Start Date: November 16, 2010
First Submitted: September 02, 2010
Last Updated: February 14, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: Belgium, France, Netherlands, Sweden
Conditions: Diabetes Mellitus, Type 1
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Study Description

Brief 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

Detailed Description

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
Condition or disease Intervention/treatment Phase

Diabetes Mellitus, Type 1

Drug: HUMAN INSULIN (BIOSYNTHETIC)
Other Names
HR1799
Drug: Insuplant
Other Names
Human insulin semi synthetic porcine derived
Phase 3

Tracking Information

First Submitted DateSeptember 02, 2010
Last Update Posted DateFebruary 14, 2018
Start DateNovember 16, 2010
Actual Completion DateFebruary 01, 2018
Primary Completion DateFebruary 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change in glycosylated hemoglobin (HbA1c) [Time Frame: From baseline to 6 months]

  • Refill accuracy between the 2 insulin groups [Time Frame: During 4 refill cycles]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia [Time Frame: From baseline to 6 months]

  • Occurrence of hyperglycaemia [Time Frame: From baseline to 6 months]

  • Occurrence of diabetic ketoacidosis [Time Frame: From baseline to 6 months]

  • Change in insulin dose [Time Frame: From baseline to 6 months]

  • Antibody assessments (anti-Insulin antibodies) [Time Frame: From baseline to 6 months]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleBenefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
Official TitleEvaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml
Brief 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

Detailed Description

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

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
479
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Diabetes Mellitus, Type 1
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: HUMAN INSULIN (BIOSYNTHETIC)

Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml

Other Names
HR1799
Drug: Insuplant

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

Other Names
Human insulin semi synthetic porcine derived
Study Groups/Cohorts
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.

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.

Study Arms
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.
Drug : HUMAN INSULIN (BIOSYNTHETIC)
Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml

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.
Drug : Insuplant
Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use Dose regimen:

Arm Intervention/Treatment
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.
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.
Drug : Insuplant

Recruitment Information

Recruitment Status:Completed
Enrollment479
Completion DateFebruary 01, 2018
Eligibility Criteria: 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Belgium
France
Netherlands
Sweden

Administrative Information

NCT Number:NCT01194882
Other Study ID Numbers
HUBIN_L_05335
2010-021373-37
U1111-1116-7658
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi