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A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562313
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Adocia

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:

  • 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. Pharmacokinetics: AUClis 0-30min [ Time Frame: 30 minutes ]
    Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes


Secondary Outcome Measures :
  1. AUClis_0-6h [ Time Frame: up to 6 Hours ]
    Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose

  2. Cmax [ Time Frame: up to 6 Hours ]
    Maximum insulin Concentration following a bolus dose

  3. tCmax [ Time Frame: up to 6 Hours ]
    Time to Maximum insulin Concentration following a bolus dose

  4. BGmax [ Time Frame: up to 6 Hours ]
    Maximum Blood Glucose after start of an individualised standardised meal intake

  5. tBGmax [ Time Frame: up to 6 Hours ]
    Time to Maximum Blood Glucose concentration

  6. Compatibility [ Time Frame: up to 14 days ]
    Number of suspected episodes of infusion set occlusion or leakage

  7. Adverse Events [ Time Frame: up to 12 weeks ]
    Number of Adverse Events

  8. Local tolerability [ Time Frame: up to 12 weeks ]
    Number of injection site reactions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Germany
Profil GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
Eli Lilly and Company
Investigators
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Principal Investigator: Tim Heise, MD Profil GmbH
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02562313    
Other Study ID Numbers: BC3-CT015
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs