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

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 1	Drug: HUMAN INSULIN (BIOSYNTHETIC) Other Names HR1799 Drug: Insuplant Other Names Human insulin semi synthetic porcine derived	Phase 3

Tracking Information

First Submitted Date	September 02, 2010
Last Update Posted Date	February 14, 2018
Start Date	November 16, 2010
Actual Completion Date	February 01, 2018
Primary Completion Date	February 01, 2018
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

• Change in glycosylated hemoglobin (HbA1c) [Time Frame: From baseline to 6 months]

• Refill accuracy between the 2 insulin groups [Time Frame: During 4 refill cycles]

Original Primary Outcome Measures

Current Secondary Outcome Measures

• 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]

Original Secondary Outcome Measures

Study Design

Brief Title	Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
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
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
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
Study Type	Interventional
Study Phase	Phase 3
Estimated Enrollment	479
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Single
Primary Purpose	Treatment
Conditions	Diabetes Mellitus, Type 1
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Drug: HUMAN INSULIN (BIOSYNTHETIC) Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml Other Names HR1799 Drug: Insuplant Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use Dose regimen: Other Names Human insulin semi synthetic porcine derived
Study Groups/Cohorts	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. 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.
Study Arms	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 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:

Arm	Intervention/Treatment
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
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:

Recruitment Information

Recruitment Status:	Completed
Enrollment	479
Completion Date	February 01, 2018
Eligibility 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.
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Belgium France Netherlands Sweden

Administrative Information

NCT Number:	NCT01194882
Other Study ID Numbers	HUBIN_L_05335 2010-021373-37 U1111-1116-7658
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	,
Study Sponsor	Sanofi
Collaborators	Not Available
Investigators	Study Director Clinical Sciences & Operations Sanofi