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
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: BioChaperone insulin lispro
- Registration Number
- NCT02528396
- Lead Sponsor
- Adocia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Humalog® Humalog® - BioChaperone insulin lispro BioChaperone insulin lispro -
- Primary Outcome Measures
Name Time Method AUCΔBG0-2h (timepoint 0 = administration of the meal) 2 hours Incremental area under the blood glucose (BG) concentration-time curve from 0-2 hours after a meal on day 1-3 \[comparison between treatments Biochaperone insulin lispro vs. lispro (Humalog®)\]
AUClispro 0-30min (timepoint 0 = time of dosing) 30 minutes 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®))
- Secondary Outcome Measures
Name Time Method AUClispro_0-6h 6 Hours Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose
Cmax_lispro up to 6 Hours Maximum serum insulin lispro concentration
Tmax_lispro up to 6 Hours Time to maximum observed serum insulin lispro concentration
AUCBG_0-6h 6 Hours Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours
ΔBGmax 6 Hours Maximum blood glucose (BG) excursion after a standard meal (0-6 hours)
Adverse events Up to 3 months Number of Adverse events
Local tolerability injection site reactions 14 days Injection site reactions over 14 days of exposure
Trial Locations
- Locations (1)
Profil GmbH
🇩🇪Neuss, Germany