Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatments human insulin (biosynthetic), insuplant
Phase phase 3
Sponsor Sanofi
Start date November 2010
End date October 2016
Trial size 458 participants
Trial identifier NCT01194882, 2010-021373-37, HUBIN_L_05335, U1111-1116-7658

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(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.
human insulin (biosynthetic) HR1799
Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml
(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.
insuplant Human insulin semi synthetic porcine derived
Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use Dose regimen:

Primary Outcomes

Measure
Refill accuracy between the 2 insulin groups
time frame: During 4 refill cycles
Change in glycosylated hemoglobin (HbA1c)
time frame: From baseline to 6 months

Secondary Outcomes

Measure
Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia
time frame: From baseline to 6 months
Occurrence of hyperglycaemia
time frame: From baseline to 6 months
Occurrence of diabetic ketoacidosis
time frame: From baseline to 6 months
Change in insulin dose
time frame: From baseline to 6 months
Antibody assessments (anti-Insulin antibodies)
time frame: From baseline to 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Sanofi.