Type 1 Diabetes Mellitus Clinical Trial
Official title:
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
Verified date | November 2016 |
Source | Adocia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Type 1 diabetes for at least 12 months - Body Mass Index (BMI) between 18.5 and 28.5 kg/m^2, both inclusive - 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. - HbA1c <= 9.0%. - Total insulin dose of < 1.2 (I)U/kg/day - 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). - Fasting C-peptide <= 0.30 nmol/L Exclusion Criteria: - Known or suspected hypersensitivity to Investigational Medicinal Product(s) (IMP(s)) or related products - Type 2 diabetes mellitus - Previous participation in this trial. - Receipt of any investigational product in a clinical trial within 60 days before randomisation in this trial - Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening test - Presence of clinically significant acute gastrointestinal symptoms - Known slowing of gastric emptying and or gastrointestinal surgery - Unusual meal habits and special dietary requirements or unwillingness to eat the food provided in the trial - History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening - History of abscess at the infusion site within 6 months prior to screening - Hypoglycaemia unawareness as judged by the Investigator - History of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Profil GmbH | Neuss |
Lead Sponsor | Collaborator |
---|---|
Adocia | Eli Lilly and Company |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacodynamics: ?AUCBG 0-2h | Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal. | 2 Hours | No |
Primary | Pharmacokinetics: AUClis 0-30min | Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes | 30 minutes | No |
Secondary | AUClis_0-6h | Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose | up to 6 Hours | No |
Secondary | Cmax | Maximum insulin Concentration following a bolus dose | up to 6 Hours | No |
Secondary | tCmax | Time to Maximum insulin Concentration following a bolus dose | up to 6 Hours | No |
Secondary | BGmax | Maximum Blood Glucose after start of an individualised standardised meal intake | up to 6 Hours | No |
Secondary | tBGmax | Time to Maximum Blood Glucose concentration | up to 6 Hours | No |
Secondary | Compatibility | Number of suspected episodes of infusion set occlusion or leakage | up to 14 days | No |
Secondary | Adverse Events | Number of Adverse Events | up to 12 weeks | Yes |
Secondary | Local tolerability | Number of injection site reactions | up to 12 weeks | Yes |
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