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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

Sponsor
Adocia (Industry)
Overall Status
Completed
CT.gov ID
NCT02562326
Collaborator
Eli Lilly and Company (Industry)
51
Enrollment
2
Locations
2
Arms
4
Duration (Months)
25.5
Patients Per Site
6.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Sep 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pharmacodynamics: ΔAUCBG 0-2h [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 [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 [up to 6 hours]

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

  2. Cmax_lisp [up to 6 hours]

    Maximum serum insulin lispro Concentration

  3. tmax_lisp [up to 6 hours]

    Time to maximum observed serum insulin lispro concentration

  4. CmaxBG [up to 6 hours]

    Maximum Blood Glucose after an individualised standard meal

  5. AUCBG_0-6h [up to 6 hours]

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

  6. Adverse Events [up to 8 weeks]

    Number of Adverse Events

  7. Local tolerability [up to 8 weeks]

    Record of injection site reaction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Profil Mainz GmbH & Co.KG Mainz Germany 44116
2 Profil GmbH Neuss Germany 41460

Sponsors and Collaborators

  • Adocia
  • Eli Lilly and Company

Investigators

  • Principal Investigator: Grit Andersen, MD, Profil GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adocia
ClinicalTrials.gov Identifier:
NCT02562326
Other Study ID Numbers:
  • BC3-CT014
First Posted:
Sep 29, 2015
Last Update Posted:
Apr 29, 2016
Last Verified:
Apr 1, 2016
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Lispro

Study Results

No Results Posted as of Apr 29, 2016