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
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BioChaperone insulin lispro
Humalog®
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
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
Sites / Locations
- Profil GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BioChaperone insulin lispro
Humalog®
Arm Description
Outcomes
Primary Outcome Measures
AUCΔBG0-2h (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®)]
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®))
Secondary Outcome Measures
AUClispro_0-6h
Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose
Cmax_lispro
Maximum serum insulin lispro concentration
Tmax_lispro
Time to maximum observed serum insulin lispro concentration
AUCBG_0-6h
Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours
ΔBGmax
Maximum blood glucose (BG) excursion after a standard meal (0-6 hours)
Adverse events
Number of Adverse events
Local tolerability injection site reactions
Injection site reactions over 14 days of exposure
Full Information
NCT ID
NCT02528396
First Posted
August 18, 2015
Last Updated
March 14, 2016
Sponsor
Adocia
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT02528396
Brief 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
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
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adocia
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BioChaperone insulin lispro
Arm Type
Experimental
Arm Title
Humalog®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BioChaperone insulin lispro
Intervention Description
Injection at t0,or t+15 minutes or t-15minutes with test meal
Intervention Type
Drug
Intervention Name(s)
Humalog®
Intervention Description
Injection at t0,or t+15 minutes or t-15minutes with test meal
Primary Outcome Measure Information:
Title
AUCΔBG0-2h (timepoint 0 = administration of the meal)
Description
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®)]
Time Frame
2 hours
Title
AUClispro 0-30min (timepoint 0 = time of dosing)
Description
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®))
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
AUClispro_0-6h
Description
Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose
Time Frame
6 Hours
Title
Cmax_lispro
Description
Maximum serum insulin lispro concentration
Time Frame
up to 6 Hours
Title
Tmax_lispro
Description
Time to maximum observed serum insulin lispro concentration
Time Frame
up to 6 Hours
Title
AUCBG_0-6h
Description
Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours
Time Frame
6 Hours
Title
ΔBGmax
Description
Maximum blood glucose (BG) excursion after a standard meal (0-6 hours)
Time Frame
6 Hours
Title
Adverse events
Description
Number of Adverse events
Time Frame
Up to 3 months
Title
Local tolerability injection site reactions
Description
Injection site reactions over 14 days of exposure
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grit Andersen, MD
Organizational Affiliation
Profil GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profil GmbH
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
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
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