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

NCT02528396 | Completed Phase 1

• 1 other identifier: BC3-CT013
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• AUCΔBG0-2h (timepoint 0 = administration of the meal)

  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 hours

• AUClispro 0-30min (timepoint 0 = time of dosing)

  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®))

  30 minutes

Secondary Outcomes (7)

• AUClispro_0-6h

  6 Hours

• Cmax_lispro

  up to 6 Hours

• Tmax_lispro

  up to 6 Hours

• AUCBG_0-6h

  6 Hours

• ΔBGmax

  6 Hours

Study Arms (2)

BioChaperone insulin lispro

EXPERIMENTAL

Drug: BioChaperone insulin lispro

Humalog®

ACTIVE COMPARATOR

Drug: Humalog®

Interventions

BioChaperone insulin lispro DRUG

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

BioChaperone insulin lispro

Humalog® DRUG

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

Humalog®

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adocia: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Profil GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 19, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

DE (1)