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

• Sponsor: Adocia (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02528396
• Collaborator: Eli Lilly and Company (Industry)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Drug: BioChaperone insulin lispro; Drug: Humalog®	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Aug 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BioChaperone insulin lispro	Drug: BioChaperone insulin lispro; Injection at t0,or t+15 minutes or t-15minutes with test meal
Active Comparator: Humalog®	Drug: Humalog®; Injection at t0,or t+15 minutes or t-15minutes with test meal

Outcome Measures

Primary Outcome Measures

1. 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®)]

2. 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

1. AUClispro_0-6h [6 Hours]

   Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose

2. Cmax_lispro [up to 6 Hours]

   Maximum serum insulin lispro concentration

3. Tmax_lispro [up to 6 Hours]

   Time to maximum observed serum insulin lispro concentration

4. AUCBG_0-6h [6 Hours]

   Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours

5. ΔBGmax [6 Hours]

   Maximum blood glucose (BG) excursion after a standard meal (0-6 hours)

6. Adverse events [Up to 3 months]

   Number of Adverse events

7. Local tolerability injection site reactions [14 days]

   Injection site reactions over 14 days of exposure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Profil GmbH	Neuss		Germany	41460

Sponsors and Collaborators

• Adocia
• Eli Lilly and Company

Investigators

• Principal Investigator: Grit Andersen, MD, Profil GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adocia
• ClinicalTrials.gov Identifier: NCT02528396
• Other Study ID Numbers: BC3-CT013
• First Posted: Aug 19, 2015
• Last Update Posted: Mar 16, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Lispro

Study Results

No Results Posted as of Mar 16, 2016