A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
Study Details
Study Description
Brief Summary
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:
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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.
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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).
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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 |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BioChaperone insulin lispro
|
Drug: BioChaperone insulin lispro
BioChaperone insulin lispro bolus infusion followed by test meal intake
|
| Active Comparator: Humalog® Insulin lispro |
Drug: Humalog®
Humalog® bolus infusion followed by test meal intake
|
Outcome Measures
Primary Outcome Measures
- Pharmacodynamics: ΔAUCBG 0-2h [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 [30 minutes]
Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes
Secondary Outcome Measures
- AUClis_0-6h [up to 6 Hours]
Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose
- Cmax [up to 6 Hours]
Maximum insulin Concentration following a bolus dose
- tCmax [up to 6 Hours]
Time to Maximum insulin Concentration following a bolus dose
- BGmax [up to 6 Hours]
Maximum Blood Glucose after start of an individualised standardised meal intake
- tBGmax [up to 6 Hours]
Time to Maximum Blood Glucose concentration
- Compatibility [up to 14 days]
Number of suspected episodes of infusion set occlusion or leakage
- Adverse Events [up to 12 weeks]
Number of Adverse Events
- Local tolerability [up to 12 weeks]
Number of injection site reactions
Eligibility Criteria
Criteria
Inclusion Criteria:
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Type 1 diabetes for at least 12 months
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Body Mass Index (BMI) between 18.5 and 28.5 kg/m^2, both inclusive
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Using or having used a Roche CSII system (Accu-Chek® Spirit Combo/ Accu- Chek® Spirit) for at least 6 months before screening. In Part B subjects using any form of CSII treatment for at least 6 months before screening will be included.
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HbA1c <= 9.0%.
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Total insulin dose of < 1.2 (I)U/kg/day
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Ability to calculate insulin bolus manually or using a bolus calculator and willingness to consume regular meals, perform carbohydrate counting, self-monitoring of plasma glucose (SMPG) profiles and use of Continuous Glucose Monitoring (CGM).
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Fasting C-peptide <= 0.30 nmol/L
Exclusion Criteria:
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Known or suspected hypersensitivity to Investigational Medicinal Product(s) (IMP(s)) or related products
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Type 2 diabetes mellitus
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Previous participation in this trial.
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Receipt of any investigational product in a clinical trial within 60 days before randomisation in this trial
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Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening test
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Presence of clinically significant acute gastrointestinal symptoms
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Known slowing of gastric emptying and or gastrointestinal surgery
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Unusual meal habits and special dietary requirements or unwillingness to eat the food provided in the trial
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History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening
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History of abscess at the infusion site within 6 months prior to screening
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Hypoglycaemia unawareness as judged by the Investigator
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History of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Profil GmbH | Neuss | Germany | 41460 |
Sponsors and Collaborators
- Adocia
- Eli Lilly and Company
Investigators
- Principal Investigator: Tim Heise, MD, Profil GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BC3-CT015