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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528396
• Other study ID #: BC3-CT013
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2015
• Last updated: March 14, 2016
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• BioChaperone insulin lispro
Injection at t0,or t+15 minutes or t-15minutes with test meal
• Humalog®
Injection at t0,or t+15 minutes or t-15minutes with test meal

Locations

Country	Name	City	State
Germany	Profil GmbH	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
Adocia	Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC?BG0-2h (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	No
Primary	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	No
Secondary	AUClispro_0-6h	Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose	6 Hours	No
Secondary	Cmax_lispro	Maximum serum insulin lispro concentration	up to 6 Hours	No
Secondary	Tmax_lispro	Time to maximum observed serum insulin lispro concentration	up to 6 Hours	No
Secondary	AUCBG_0-6h	Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours	6 Hours	No
Secondary	?BGmax	Maximum blood glucose (BG) excursion after a standard meal (0-6 hours)	6 Hours	No
Secondary	Adverse events	Number of Adverse events	Up to 3 months	Yes
Secondary	Local tolerability injection site reactions	Injection site reactions over 14 days of exposure	14 days	Yes