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

February 14, 2018 updated by: Sanofi

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

479

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Investigational Site Number 056-001
  • France
      • Corbeil Essonnes, France, 91100
        • Investigational Site Number 250-004
      • Dijon, France, 21000
        • Investigational Site Number 250-008
      • Dommartin Les Toul, France, 54200
        • Investigational Site Number 250-003
      • LILLE Cedex, France, 59037
        • Investigational Site Number 250-009
      • Le Mans Cedex 9, France, 72037
        • Investigational Site Number 250-012
      • MONTPELLIER Cedex 5, France, 34295
        • Investigational Site Number 250-001
      • Marseille, France, 13385
        • Investigational Site Number 250-007
      • Paris, France, 75014
        • Investigational Site Number 250-005
      • Pessac Cedex, France, 33604
        • Investigational Site Number 250-010
      • ST PRIEST EN JAREZ Cedex, France, 42277
        • Investigational Site Number 250-011
      • Strasbourg, France, 67091
        • Investigational Site Number 250-002
      • TOULOUSE Cedex 9, France, 31059
        • Investigational Site Number 250-006
  • Netherlands
      • Den Haag, Netherlands, 2512VA
        • Investigational Site Number 528003
      • Roermond, Netherlands, 6043CV
        • Investigational Site Number 528002
      • Zwolle, Netherlands, 8025AB
        • Investigational Site Number 528001
  • Sweden
      • Stockholm, Sweden
        • Investigational Site Number 752-001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)
Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml
Other Names:
  • HR1799
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:

Other Names:
  • Human insulin semi synthetic porcine derived

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Refill accuracy between the 2 insulin groups
Time Frame: During 4 refill cycles
During 4 refill cycles
Change in glycosylated hemoglobin (HbA1c)
Time Frame: From baseline to 6 months
From baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia
Time Frame: From baseline to 6 months
From baseline to 6 months
Occurrence of hyperglycaemia
Time Frame: From baseline to 6 months
From baseline to 6 months
Occurrence of diabetic ketoacidosis
Time Frame: From baseline to 6 months
From baseline to 6 months
Change in insulin dose
Time Frame: From baseline to 6 months
From baseline to 6 months
Antibody assessments (anti-Insulin antibodies)
Time Frame: From baseline to 6 months
From baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 16, 2010

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 2, 2010

First Posted (Estimate)

September 3, 2010

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUBIN_L_05335
  • 2010-021373-37 (EudraCT Number)
  • U1111-1116-7658 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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