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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

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ClinicalTrials.gov Identifier: NCT02562326
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : April 29, 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 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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: BioChaperone insulin lispro Drug: Humalog® Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016


Arm Intervention/treatment
Experimental: BioChaperone insulin lispro Drug: BioChaperone insulin lispro
Injection immediately before the start of the individualised standard meal

Active Comparator: Humalog® Drug: Humalog®
Injection immediately before the start of the individualised standard meal




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02562326


Locations
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Germany
Profil Mainz GmbH & Co.KG
Mainz, Germany, 44116
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: NCT02562326    
Other Study ID Numbers: BC3-CT014
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs