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Trial record 1 of 1 for:    NCT02528396
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To Investigate the Efficacy and Safety of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02528396
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Adocia

Brief Summary:

This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro compared to Humalog®. The assessments will be conducted before and after a period of multiple daily dose administrations for 14 days. The meal tolerance test will be performed on day 1-3 and on day 14 of each period. Furthermore the study aims at investigating Post-prandial glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when injected at various injection meal intervals (-15min, 0 minutes, +15 minutes).

Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will be performed during the 14 day treatment periods.


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 : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Monocentric, Double-blind, Multiple Daily Dose, Two-period, 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus
Study Start Date : August 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: BioChaperone insulin lispro Drug: BioChaperone insulin lispro
Injection at t0,or t+15 minutes or t-15minutes with test meal

Active Comparator: Humalog® Drug: Humalog®
Injection at t0,or t+15 minutes or t-15minutes with test meal




Primary Outcome Measures :
  1. AUCΔBG0-2h (timepoint 0 = administration of the meal) [ Time Frame: 2 hours ]
    Incremental area under the blood glucose (BG) concentration-time curve from 0-2 hours after a meal on day 1-3 [comparison between treatments Biochaperone insulin lispro vs. lispro (Humalog®)]

  2. AUClispro 0-30min (timepoint 0 = time of dosing) [ Time Frame: 30 minutes ]
    Area under the serum insulin lispro concentration-time curve from 0-30 minutes after bolus dose on one of days 1, 2 or 3 (comparison between treatments BioChaperone insulin lispro vs. lispro (Humalog®))


Secondary Outcome Measures :
  1. AUClispro_0-6h [ Time Frame: 6 Hours ]
    Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose

  2. Cmax_lispro [ Time Frame: up to 6 Hours ]
    Maximum serum insulin lispro concentration

  3. Tmax_lispro [ Time Frame: up to 6 Hours ]
    Time to maximum observed serum insulin lispro concentration

  4. AUCBG_0-6h [ Time Frame: 6 Hours ]
    Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours

  5. ΔBGmax [ Time Frame: 6 Hours ]
    Maximum blood glucose (BG) excursion after a standard meal (0-6 hours)

  6. Adverse events [ Time Frame: Up to 3 months ]
    Number of Adverse events

  7. Local tolerability injection site reactions [ Time Frame: 14 days ]
    Injection site reactions over 14 days of exposure



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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 mellitus (as diagnosed clinically) ≥ 12 months
  • Treated with multiple daily insulin injections (no pump users) ≥ 12 months
  • Current total daily insulin treatment <1.2 (I)U/kg/day
  • Body mass index (BMI) 18.5-28.0 kg/m² (both inclusive)
  • HbA1c (N-(1-deoxy)-fructosyl-haemoglobin) ≤ 9.0% by local laboratory analysis
  • Fasting C-peptide ≤ 0.30 nmol/L

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial products or related products
  • Type 2 diabetes mellitus
  • Patients using continuous subcutaneous insulin infusion (CSII)
  • Previous participation in this trial. Participation is defined as randomised
  • The receipt of any investigational product within 3 months prior to this trial
  • Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease
  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator
  • Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption
  • Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial

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): NCT02528396


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: Grit Andersen, MD Profil GmbH
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02528396    
Other Study ID Numbers: BC3-CT013
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs