Clinical trial NCT02528396: 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
Official title: A Randomized, Monocentric, Double-blind, Multiple Daily Dose, Two-period, 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Adocia
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2015-08-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: AUCΔBG0-2h (timepoint 0 = administration of the meal)
timeFrame: 2 hours
measure: AUClispro 0-30min (timepoint 0 = time of dosing)
timeFrame: 30 minutes
Secondary outcomes:
measure: AUClispro_0-6h
timeFrame: 6 Hours
measure: Cmax_lispro
timeFrame: up to 6 Hours
measure: Tmax_lispro
timeFrame: up to 6 Hours
measure: AUCBG_0-6h
timeFrame: 6 Hours
measure: ΔBGmax
timeFrame: 6 Hours
measure: Adverse events
timeFrame: Up to 3 months
measure: Local tolerability injection site reactions
timeFrame: 14 days
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil GmbH
Study officials:
affiliation: Profil GmbH
name: Grit Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: