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

NCT01194882 | Completed Phase 3

• 3 other identifiers: HUBIN_L_053352010-021373-37U1111-1116-7658
• Study Type: interventional
• Target: 479
• Locations: 4 countries
• Sites: 17

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

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Refill accuracy between the 2 insulin groups

  During 4 refill cycles

• Change in glycosylated hemoglobin (HbA1c)

  From baseline to 6 months

Secondary Outcomes (5)

• Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia

  From baseline to 6 months

• Occurrence of hyperglycaemia

  From baseline to 6 months

• Occurrence of diabetic ketoacidosis

  From baseline to 6 months

• Change in insulin dose

  From baseline to 6 months

• Antibody assessments (anti-Insulin antibodies)

  From baseline to 6 months

Study Arms (2)

Insuman Implantable

EXPERIMENTAL

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)

Insuplant

ACTIVE COMPARATOR

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

Interventions

HUMAN INSULIN (BIOSYNTHETIC) DRUG

Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml

Also known as: HR1799

Insuman Implantable

Insuplant DRUG

Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use Dose regimen:

Also known as: Human insulin semi synthetic porcine derived

Insuplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (17)

Investigational Site Number 056-001

Leuven, 3000, Belgium

Location

Investigational Site Number 250-004

Corbeil-Essonnes, 91100, France

Location

Investigational Site Number 250-008

Dijon, 21000, France

Location

Investigational Site Number 250-003

Dommartin-lès-Toul, 54200, France

Location

Investigational Site Number 250-012

Le Mans, 72037, France

Location

Investigational Site Number 250-009

Lille, 59037, France

Location

Investigational Site Number 250-007

Marseille, 13385, France

Location

Investigational Site Number 250-001

Montpellier, 34295, France

Location

Investigational Site Number 250-005

Paris, 75014, France

Location

Investigational Site Number 250-010

Pessac, 33604, France

Location

Investigational Site Number 250-011

Saint-Priest-en-Jarez, 42277, France

Location

Investigational Site Number 250-002

Strasbourg, 67091, France

Location

Investigational Site Number 250-006

Toulouse, 31059, France

Location

Investigational Site Number 528002

Roermond, 6043CV, Netherlands

Location

Investigational Site Number 528003

The Hague, 2512VA, Netherlands

Location

Investigational Site Number 528001

Zwolle, 8025AB, Netherlands

Location

Investigational Site Number 752-001

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 24735100 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin; Metabolism

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 3, 2010
• Study Start: November 16, 2010
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

FR (12); NL (3); BE (1); SE (1)