A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
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|ClinicalTrials.gov Identifier: NCT02562313|
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : November 22, 2016
This study is constituted of 2 parts:
Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company). Each treatment period consists of 10 treatment days under free living conditions (e.g. home / workplace) and under standardised conditions at the clinic. Various assessments for pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are performed on selected days, including:
- Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the post-prandial glucose response for 6 hours after individualized standard meal (fixed nutrient ratio) ingestion and bolus administration via CSII.
- Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode (i.e. neither subjects nor the investigators are aware of the sensor glucose values).
- Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the Investigational Medicinal Products (IMP) during the outpatient periods.
Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period cross-over study aiming at comparing the performance of BC Lispro and Humalog after a prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump compatibility and safety will be analyzed.
Each period will include a mixed meal tolerance test with a CSII device and a mixed meal tolerance test with the same dose of insulin administered with a syringe.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: BioChaperone insulin lispro Drug: Humalog®||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
|Experimental: BioChaperone insulin lispro||
Drug: BioChaperone insulin lispro
BioChaperone insulin lispro bolus infusion followed by test meal intake
Active Comparator: Humalog®
Humalog® bolus infusion followed by test meal intake
- Pharmacodynamics: ΔAUCBG 0-2h [ Time Frame: 2 Hours ]Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal.
- Pharmacokinetics: AUClis 0-30min [ Time Frame: 30 minutes ]Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes
- AUClis_0-6h [ Time Frame: up to 6 Hours ]Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose
- Cmax [ Time Frame: up to 6 Hours ]Maximum insulin Concentration following a bolus dose
- tCmax [ Time Frame: up to 6 Hours ]Time to Maximum insulin Concentration following a bolus dose
- BGmax [ Time Frame: up to 6 Hours ]Maximum Blood Glucose after start of an individualised standardised meal intake
- tBGmax [ Time Frame: up to 6 Hours ]Time to Maximum Blood Glucose concentration
- Compatibility [ Time Frame: up to 14 days ]Number of suspected episodes of infusion set occlusion or leakage
- Adverse Events [ Time Frame: up to 12 weeks ]Number of Adverse Events
- Local tolerability [ Time Frame: up to 12 weeks ]Number of injection site reactions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562313
|Neuss, Germany, 41460|
|Principal Investigator:||Tim Heise, MD||Profil GmbH|