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: July 28, 2014
Last verified: July 2014
  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:


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 2014
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 28, 2014
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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014