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NCT Number: NCT02528396

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BioChaperone insulin lispro

Drug

Injection at t0,or t+15 minutes or t-15minutes with test meal

Humalog®

Drug

Injection at t0,or t+15 minutes or t-15minutes with test meal

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2015
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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