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

Adocia

Status and phase

Completed

Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: Humalog®

Drug: BioChaperone insulin lispro

Study type

Interventional

Funder types

Industry

Identifiers

NCT02528396

BC3-CT013

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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