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OpenTrials
Completed

NCT Number: NCT01194882

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

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 056-001, Leuven, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HUMAN INSULIN (BIOSYNTHETIC)

Drug

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

Other names: HR1799

Insuplant

Drug

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

Dose regimen:

Other names: Human insulin semi synthetic porcine derived

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Sep 3, 2010
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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