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Completed

NCT Number: NCT02562326

A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus

This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of multiple daily dose administrations for 14 days. Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be determined at the screening visit. During the outpatient phase the subjects will keep their basal insulin constant (except changes for safety reason). They will self-measure blood glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2 hours post-prandial and at bedtime).

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Mainz GmbH & Co.KG, Mainz, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus ≥ 12 months
  • Treated with stable multiple daily insulin ≥ 3 months (basal-bolus therapy or only bolus insulin therapy)
  • Current total daily insulin treatment <1.2 (I)U/kg/day
  • Body Mass Index below or equal to 40.0 kg/m²
  • HbA1c ≤ 9.0% by local laboratory analysis

Exclusion criteria

  • Known or suspected hypersensitivity to trial products or related products
  • Type 1 diabetes mellitus
  • Previous participation in this trial
  • The receipt of any investigational product within 60 days 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
  • Presence of renal impairment (Estimated Glomerular filtration Rate (eGFR)<60 milliliters/minute/1.73m²)
  • Presence of late diabetic complications and/or acute coronary heart disease.
  • 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
  • Current treatment with corticosteroids

Treatment and study plan

BioChaperone insulin lispro

Drug

Injection immediately before the start of the individualised standard meal

Humalog®

Drug

Injection immediately before the start of the individualised standard meal

Primary outcomes

  1. Pharmacodynamics: ΔAUCBG 0-2h

    Time frame: 2 hours

    Incremental Area Under Blood Glucose concentration-time Curve from 0-2 hours after a meal (comparison between BioChaperone insulin lispro and insulin lispro)

  2. Pharmacokinetics: AUClis 0-30min

    Time frame: 30 minutes

    Area Under the serum insulin Lispro concentration-time Curve 0-30 minutes (comparison between BioChaperone insulin lispro and insulin lispro)

Secondary outcomes

  1. AUClisp_0-6h

    Time frame: up to 6 hours

    Area Under the serum insulin Lispro concentration-time Curve from 0-6 hours after bolus dose

  2. Cmax_lisp

    Time frame: up to 6 hours

    Maximum serum insulin lispro Concentration

  3. tmax_lisp

    Time frame: up to 6 hours

    Time to maximum observed serum insulin lispro concentration

  4. CmaxBG

    Time frame: up to 6 hours

    Maximum Blood Glucose after an individualised standard meal

  5. AUCBG_0-6h

    Time frame: up to 6 hours

    Area Under the Curve under the Blood Glucose concentration time curve from 0-6 hours

  6. Adverse Events

    Time frame: up to 8 weeks

    Number of Adverse Events

  7. Local tolerability

    Time frame: up to 8 weeks

    Record of injection site reaction

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Randomised, Monocentric, Double-blind, Multiple Daily Dose, Two-period 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualised Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2015
Registry last updated
Apr 29, 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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