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

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ClinicalTrials.gov Identifier: NCT01194882
Recruitment Status : Completed
First Posted : September 3, 2010
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

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


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: HUMAN INSULIN (BIOSYNTHETIC) Drug: Insuplant Phase 3

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  (Clinical Trial)
Actual Enrollment : 479 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : November 16, 2010
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

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 Name: 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 Name: Human insulin semi synthetic porcine derived



Primary Outcome Measures :
  1. Refill accuracy between the 2 insulin groups [ Time Frame: During 4 refill cycles ]
  2. Change in glycosylated hemoglobin (HbA1c) [ Time Frame: From baseline to 6 months ]

Secondary Outcome Measures :
  1. Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia [ Time Frame: From baseline to 6 months ]
  2. Occurrence of hyperglycaemia [ Time Frame: From baseline to 6 months ]
  3. Occurrence of diabetic ketoacidosis [ Time Frame: From baseline to 6 months ]
  4. Change in insulin dose [ Time Frame: From baseline to 6 months ]
  5. Antibody assessments (anti-Insulin antibodies) [ Time Frame: From baseline to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194882


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01194882     History of Changes
Other Study ID Numbers: HUBIN_L_05335
2010-021373-37 ( EudraCT Number )
U1111-1116-7658 ( Other Identifier: UTN )
First Posted: September 3, 2010    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs