A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

• Sponsor: Adocia (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02213146
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 3
• Duration (Months): 10
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.

The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg.

This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 separate dosing visits.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 1	Drug: BioChaperone human insulin; Drug: Huminsulin® Normal; Drug: Humalog®	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Area under the curve (AUCins(0-1h)) [1 hour]

   Area under the human insulin serum concentration - time curve from t=0 to 1 hour

Secondary Outcome Measures

1. Pharmacokinetics: Early t0.5max ins/lisp [up to 10 hours post administration]

   Time to first observed half maximum serum human insulin / insulin lispro concentration

2. Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours [10 hours]

   Area under the glucose infusion rate - time curve from t=0 to 10 hours

3. Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax) [10 hours]

   Time to first observed half maximum glucose infusion rate

4. Glucodynamics: GIRmax - Maximum glucose infusion rate [10 hours]

   Maximum glucose infusion rate

5. Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration [10 hours]

   Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours

6. Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration [10 hours]

   Time to maximum observed serum human insulin concentration and insulin lispro concentration

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

   Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters

8. Pharmacokinetics: Cmax(ins/lisp) [up to 10 hours]

   Maximum observed human insulin / insulin lispro serum concentration

9. Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours [2 hours post administration]

   Area under the glucose infusion rate - time curve from t=0 to 2 hours

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male subject with type 1 diabetes for at least 12 months

• Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months

• Body mass index: 18.5-28.0 kg BW·m-2

• HbA1c: ≤ 9.0%

Exclusion Criteria:

• Diabetes mellitus type 2

• Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial

• Clinically significant abnormalities as judged by the Investigator

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

• History of alcoholism or drug/chemical abuse as per Investigator's judgement

• 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: NCT02213146
• Other Study ID Numbers: BC3-CT010
• First Posted: Aug 11, 2014
• Last Update Posted: Jun 1, 2017
• Last Verified: Jun 1, 2015

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

Study Results

No Results Posted as of Jun 1, 2017