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

NCT02562326 | Completed Phase 1

• 1 other identifier: BC3-CT014
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Pharmacodynamics: ΔAUCBG 0-2h

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

  2 hours

• Pharmacokinetics: AUClis 0-30min

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

  30 minutes

Secondary Outcomes (7)

• AUClisp_0-6h

  up to 6 hours

• Cmax_lisp

  up to 6 hours

• tmax_lisp

  up to 6 hours

• CmaxBG

  up to 6 hours

• AUCBG_0-6h

  up to 6 hours

Study Arms (2)

BioChaperone insulin lispro

EXPERIMENTAL

Drug: BioChaperone insulin lispro

Humalog®

ACTIVE COMPARATOR

Drug: Humalog®

Interventions

BioChaperone insulin lispro DRUG

Injection immediately before the start of the individualised standard meal

BioChaperone insulin lispro

Humalog® DRUG

Injection immediately before the start of the individualised standard meal

Humalog®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adocia: lead
• Eli Lilly and Company: collaborator

Study Sites (2)

Profil Mainz GmbH & Co.KG

Mainz, 44116, Germany

Location

Profil GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Grit Andersen, MD

  Profil GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 29, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 29, 2016

Record last verified: 2016-04

Locations

DE (2)