Clinical Trials Register

Summary
EudraCT Number:	2014-003144-12
Sponsor's Protocol Code Number:	DBC-14LIPOINJ01
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-08-18
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2014-003144-12

A.3

Full title of the trial

A trial to compare the pharmacokinetics and pharmacodynamics of insulin lispro administered s.c. into lipohypertrophic or normal abdominal adipose tissue in subjects with diabetes mellitus type 1

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A trial to compare the pharmacokinetics and pharmacodynamics of insulin lispro administered s.c. into lipohypertrophic or normal abdominal adipose tissue in subjects with diabetes mellitus type 1

A.4.1

Sponsor's protocol code number

DBC-14LIPOINJ01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Profil Institut für Stoffwechselforschung GmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Becton Dickinson and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Profil Institut für Stoffwechselforschung GmbH
B.5.2	Functional name of contact point	Regulatory Affairs Manager
B.5.3	Address:
B.5.3.1	Street Address	Hellersbergstr. 9
B.5.3.2	Town/ city	Neuss
B.5.3.3	Post code	41460
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4921314018145
B.5.5	Fax number	+4921314018517
B.5.6	E-mail	regulatory@profil.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Humalog®
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Humalog®
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN LISPRO
D.3.9.1	CAS number	133107-64-9
D.3.9.4	EV Substance Code	SUB08198MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Diabetes mellitus

E.1.1.1

Medical condition in easily understood language

Diabetes mellitus

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10045228
E.1.2	Term	Type I diabetes mellitus
E.1.2	System Organ Class	100000004861

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Compare the pharmacokinetic and pharmacodynamic effects of insulin lispro during the first 4 hours after s.c. administration into either lipohypertrophic or normal adipose tissue during a euglycaemic clamp examination.

E.2.2

Secondary objectives of the trial

• to compare the pharmacokinetic and pharmacodynamic effects of insulin lispro during the first 4 hours after s.c. administration into either lipohypertrophic or normal adipose tissue during an MMTT
• to compare the intra-subject variability of the pharmacokinetic and pharmacodynamic efficacy of insulin lispro administration into either lipohypertrophic or normal adipose tissue
• to further compare the pharmacokinetic and pharmacodynamic effects of insulin lispro administration into either lipohypertrophic or normal adipose tissue during a euglycaemic clamp examination and MMTT

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject).
2.Male or female subject with diabetes mellitus type 1.
3.Age between 18 and 64 years, both inclusive.
4.Body Mass Index (BMI) between 18.5 and 30 kg/m2, both inclusive.
5.HbA1c ≤ 10%.
6.Negative C-peptide (≤ 0.30 nmol/L).
7.Total insulin dose of < 1.2 U/kg/day.
8.Diabetes duration of at least 3 years.
9.Stable insulin regimen (either multiple daily injection or insulin infusion pump) for at least 2 months prior to inclusion into the study, as judged by the investigator.
10.Presence of lipohypertrophic and non-lipohypertrophic adipose tissue at comparable sites, as confirmed by two independent investigators via physical examination and sonography.

E.4

Principal exclusion criteria

1.Known or suspected hypersensitivity to trial product(s) or related products.
2.Previous participation in this trial. Participation is defined as randomised.
3.Receipt of any investigational medicinal product within 30 days before randomisation in this trial.
4.History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
5.Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator.
6.Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
7.Any serious systemic infectious disease during four weeks prior to first dosing of the study drug, as judged by the investigator.
8.Clinically significant abnormal lab results for haematology, clinical chemistry, or urinalysis as judged by the investigator.
9.Abnormalities in renal function (e.g. serum creatinine > 120 µmol/L for male, >100 µmol/L for female subjects) as judged by the investigator that would pose a problem of clearance of injected insulin.
10.Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 95-140 mmHg blood pressure and for diastolic greater than 90 mmHg or symptoms and a heart rate at rest outside of 50-90 beats per minute (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial). This exclusion criterion also pertains to subjects being on anti-hypertensives.

E.5 End points

E.5.1

Primary end point(s)

PK endpoint:
•AUCINS.0-4h, area under the serum insulin concentration curve from 0 to 4 hours in each dosing interval during treatment period 1
PD endpoint:
•AUCGIR.0-4h, area under the glucose infusion rate curve from 0 to 4 hours in each dosing interval during treatment period 1

E.5.1.1

Timepoint(s) of evaluation of this end point

Data Base release

E.5.2

Secondary end point(s)

•AUCINS.0-4h area under the serum insulin concentration curve from 0 to 4 hours during treatment period 2
•AUCBG.0-4h, area under the blood glucose excursion curve in the indicated time-intervals during treatment period 2
•Intra-subject variability of AUCINS.0-4h and AUCGIR.0-4h during treatment period 1

E.5.2.1

Timepoint(s) of evaluation of this end point

Data Base release

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

different injection sites will be investigated no other medicinal product or placebo

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-09-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-11-25

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