Evaluation of Insuman Implantable 400 IU/ml in patients with Type 1 diabetes treated with the Medtronic MiniMed Implantable Pump System using Insuplant 400 IU/mL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021373-37-FR

Enrollment

459

Registered

2010-07-27

Start date

2010-09-15

Completion date

Unknown

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes

Interventions

Product Name: Insuman Implantable Pharmaceutical Form: Solution for infusion INN or Proposed INN: Insulin human Concentration unit: IU international unit(s) Concentration type: equal Trade Name: Ins

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for comparative phase • Patients already treated with Insuplant 400 IU/ml via a Medtronic MiniMed Implantable System 2007 • HbA1c = 9.0% • Patient showing a percentage of error at refill equal or below 20% • Patient undergoing a 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 Inclusion criteria for Insuplant non-comparative phase • Patients already treated with Insuplant 400 IU/ml via a Medtronic MiniMed Implantable System 2007 • Signed informed consent form prior to enrolment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria for comparative phase • Pump life time > 6 years • Pump battery voltage < 2.6 volts • Pregnancy or childbearing potential without a medically approved form of birth control

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary: • To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuplant (insuplant non-comparative phase) • To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman (insuman non-comparative phase) • To evaluate daily insulin doses • To assess the Anti-Insulin Antibodies (AIA = ADA) levels during the comparative phase ;Primary end point(s): Efficacy endpoints: • Refill accuracy between the 2 insulin groups after 4 refill cycles The refill accuracy is calculated as a difference expressed in percentage between the theoretical refill volume calculated by the PPC using programmed values and the actual refill volume used by weight measurements • HbA1c change from baseline in the 2 insulin groups after 4 refill cycles Safety endpoints: • Number of episodes of severe hypoglycaemia and non severe hypoglycaemia (<70 mg/dl) per patient (determined by SMBG or venous samples) • Number of DKA episodes (pH<7.25), • All adverse events, • Anti-insulin antibody (ADAs) levels assessment (at Baseline (visit 1) and at each subsequent refill visit up to visit 5. ;Main Objective: The general objective of the study is to show the positive benefits /risks balance of using the recombinant insulin formulation (Insuman Implantable 400 UI/ml) compared to the semi-synthetic insulin (Insuplant 400 UI). Primary: • 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 (Comparative phase = 160+/- 20 days) • To assess efficacy measured by HbA1 change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/mL group after a 4 refill cycle period (comparative phase = 160+/- 20 days)	—

Measure

Time frame

Secondary Objective: Secondary: • To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuplant (insuplant non-comparative phase) • To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman (insuman non-comparative phase) • To evaluate daily insulin doses • To assess the Anti-Insulin Antibodies (AIA = ADA) levels during the comparative phase ;Primary end point(s): Efficacy endpoints: • Refill accuracy between the 2 insulin groups after 4 refill cycles The refill accuracy is calculated as a difference expressed in percentage between the theoretical refill volume calculated by the PPC using programmed values and the actual refill volume used by weight measurements • HbA1c change from baseline in the 2 insulin groups after 4 refill cycles Safety endpoints: • Number of episodes of severe hypoglycaemia and non severe hypoglycaemia (<70 mg/dl) per patient (determined by SMBG or venous samples) • Number of DKA episodes (pH<7.25), • All adverse events, • Anti-insulin antibody (ADAs) levels assessment (at Baseline (visit 1) and at each subsequent refill visit up to visit 5. ;Main Objective: The general objective of the study is to show the positive benefits /risks balance of using the recombinant insulin formulation (Insuman Implantable 400 UI/ml) compared to the semi-synthetic insulin (Insuplant 400 UI). Primary: • 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 (Comparative phase = 160+/- 20 days) • To assess efficacy measured by HbA1 change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/mL group after a 4 refill cycle period (comparative phase = 160+/- 20 days)

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Countries

Belgium, France, Netherlands, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026