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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02528396
• Date of registration: 18/08/2015
• Prospective Registration: No
• Primary sponsor: Adocia
• Public title: 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
• Scientific 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
• Date of first enrolment: August 2015
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02528396
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Grit Andersen, MD
• Affiliation: Profil GmbH

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Drug: Humalog®

Drug: BioChaperone insulin lispro

Primary Outcome(s)

AUC?BG0-2h (timepoint 0 = administration of the meal) [Time Frame: 2 hours]

AUClispro 0-30min (timepoint 0 = time of dosing) [Time Frame: 30 minutes]

Secondary Outcome(s)

Adverse events [Time Frame: Up to 3 months]

Tmax_lispro [Time Frame: up to 6 Hours]

?BGmax [Time Frame: 6 Hours]

AUClispro_0-6h [Time Frame: 6 Hours]

Local tolerability injection site reactions [Time Frame: 14 days]

AUCBG_0-6h [Time Frame: 6 Hours]

Cmax_lispro [Time Frame: up to 6 Hours]

Secondary ID(s)

BC3-CT013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eli Lilly and Company