Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal

• Sponsor: Adocia (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02344992
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.

This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.

This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biochaperone Insulin Lispro	Drug: BioChaperone insulin lispro; Single dose of 0.2 U/kg body weight injected subcutaneously
Active Comparator: Humalog®	Drug: Humalog®; Single dose of 0.2 U/kg body weight injected subcutaneously

Outcome Measures

Primary Outcome Measures

1. Area under the blood glucose time curve: AUCbg(0-2h) [2 hours]

   Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal

Secondary Outcome Measures

1. Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h) [8 hours]

2. Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax [8 hours]

3. Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h) [8 hours]

4. Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp) [8 hours]

5. Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters [Up to 7 weeks]

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 ≥ 12 months

• Treated with multiple daily insulin injections or CSII ≥ 12 months

• BMI 18.5-28.0 kg/m² (both inclusive)

• HbA1C%≤9%

Exclusion Criteria:

• Type 2 Diabetes Mellitus

• Receipt of any trial product within 60 days 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 gastroinstestinal symptoms 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.

• Any systemic treatment with drugs known to interfere with glucose metabolism

• Use of any tobacco or nicotine-contained product within one year prior to screening

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Adocia

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: NCT02344992
• Other Study ID Numbers: BC3-CT011; 2014-005028-92
• First Posted: Jan 26, 2015
• Last Update Posted: Jun 1, 2017
• Last Verified: Jun 1, 2015

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

Study Results

No Results Posted as of Jun 1, 2017