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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HUMAN INSULIN (BIOSYNTHETIC)
Insuplant
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 056-001
  • Investigational Site Number 250-004
  • Investigational Site Number 250-008
  • Investigational Site Number 250-003
  • Investigational Site Number 250-012
  • Investigational Site Number 250-009
  • Investigational Site Number 250-007
  • Investigational Site Number 250-001
  • Investigational Site Number 250-005
  • Investigational Site Number 250-010
  • Investigational Site Number 250-011
  • Investigational Site Number 250-002
  • Investigational Site Number 250-006
  • Investigational Site Number 528003
  • Investigational Site Number 528002
  • Investigational Site Number 528001
  • Investigational Site Number 752-001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insuman Implantable

Insuplant

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Refill accuracy between the 2 insulin groups
Change in glycosylated hemoglobin (HbA1c)

Secondary Outcome Measures

Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia
Occurrence of hyperglycaemia
Occurrence of diabetic ketoacidosis
Change in insulin dose
Antibody assessments (anti-Insulin antibodies)

Full Information

First Posted
September 2, 2010
Last Updated
February 14, 2018
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01194882
Brief Title
Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 16, 2010 (undefined)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
479 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insuman Implantable
Arm Type
Experimental
Arm Description
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.
Arm Title
Insuplant
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
HUMAN INSULIN (BIOSYNTHETIC)
Other Intervention Name(s)
HR1799
Intervention Description
Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml
Intervention Type
Drug
Intervention Name(s)
Insuplant
Other Intervention Name(s)
Human insulin semi synthetic porcine derived
Intervention Description
Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use Dose regimen:
Primary Outcome Measure Information:
Title
Refill accuracy between the 2 insulin groups
Time Frame
During 4 refill cycles
Title
Change in glycosylated hemoglobin (HbA1c)
Time Frame
From baseline to 6 months
Secondary Outcome Measure Information:
Title
Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia
Time Frame
From baseline to 6 months
Title
Occurrence of hyperglycaemia
Time Frame
From baseline to 6 months
Title
Occurrence of diabetic ketoacidosis
Time Frame
From baseline to 6 months
Title
Change in insulin dose
Time Frame
From baseline to 6 months
Title
Antibody assessments (anti-Insulin antibodies)
Time Frame
From baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients already treated with Insuplant 400 IU/ml via a Medtronic Implantable System 2007 Glycosylated hemoglobin ≤9.0% Patient showing a percentage of error at refill equal or below 20% 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) Signed informed consent form prior to enrolment Exclusion criteria: Pump life time > 6 years Pump battery voltage < 2.6 volts 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 056-001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigational Site Number 250-004
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
Investigational Site Number 250-008
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Investigational Site Number 250-003
City
Dommartin Les Toul
ZIP/Postal Code
54200
Country
France
Facility Name
Investigational Site Number 250-012
City
Le Mans Cedex 9
ZIP/Postal Code
72037
Country
France
Facility Name
Investigational Site Number 250-009
City
LILLE Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number 250-007
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Investigational Site Number 250-001
City
MONTPELLIER Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number 250-005
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Investigational Site Number 250-010
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Investigational Site Number 250-011
City
ST PRIEST EN JAREZ Cedex
ZIP/Postal Code
42277
Country
France
Facility Name
Investigational Site Number 250-002
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Investigational Site Number 250-006
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Investigational Site Number 528003
City
Den Haag
ZIP/Postal Code
2512VA
Country
Netherlands
Facility Name
Investigational Site Number 528002
City
Roermond
ZIP/Postal Code
6043CV
Country
Netherlands
Facility Name
Investigational Site Number 528001
City
Zwolle
ZIP/Postal Code
8025AB
Country
Netherlands
Facility Name
Investigational Site Number 752-001
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24735100
Citation
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.
Results Reference
derived

Learn more about this trial

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

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