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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: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
 Drug: HUMAN INSULIN (BIOSYNTHETIC)
Drug: Insuplant
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 458
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194882

Locations
Belgium
Administrative office
Diegem, Belgium
France
Administrative office
Paris, France
Netherlands
Administrative office
Gouda, Netherlands
Sweden
Administrative office
Bromma, Sweden
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01194882     History of Changes
Other Study ID Numbers: HUBIN_L_05335, 2010-021373-37, U1111-1116-7658
Study First Received: September 2, 2010
Last Updated: June 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 16, 2013