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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

Tracking Information
First Submitted Date  ICMJE August 18, 2015
First Posted Date  ICMJE August 19, 2015
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE August 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
  • 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®)]
  • 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®))
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2015)
  • AUClispro_0-6h [ Time Frame: 6 Hours ]
    Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose
  • Cmax_lispro [ Time Frame: up to 6 Hours ]
    Maximum serum insulin lispro concentration
  • Tmax_lispro [ Time Frame: up to 6 Hours ]
    Time to maximum observed serum insulin lispro concentration
  • AUCBG_0-6h [ Time Frame: 6 Hours ]
    Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours
  • ΔBGmax [ Time Frame: 6 Hours ]
    Maximum blood glucose (BG) excursion after a standard meal (0-6 hours)
  • Adverse events [ Time Frame: Up to 3 months ]
    Number of Adverse events
  • Local tolerability injection site reactions [ Time Frame: 14 days ]
    Injection site reactions over 14 days of exposure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: BioChaperone insulin lispro
    Injection at t0,or t+15 minutes or t-15minutes with test meal
  • Drug: Humalog®
    Injection at t0,or t+15 minutes or t-15minutes with test meal
Study Arms  ICMJE
  • Experimental: BioChaperone insulin lispro
    Intervention: Drug: BioChaperone insulin lispro
  • Active Comparator: Humalog®
    Intervention: Drug: Humalog®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2015)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02528396
Other Study ID Numbers  ICMJE BC3-CT013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adocia
Study Sponsor  ICMJE Adocia
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Grit Andersen, MD Profil GmbH
PRS Account Adocia
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP