Clinical Trials Register

Summary
EudraCT Number:	2019-002318-37
Sponsor's Protocol Code Number:	J2H-MC-IUAA
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:	2019-10-07
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

2019-002318-37

A.3

Full title of the trial

A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients with Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy

A.3.1

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

A study in Type I Diabetes Mellitus

A.4.1

Sponsor's protocol code number

J2H-MC-IUAA

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	Eli Lilly and Company Limited
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Eli Lilly 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	Eli Lilly and Company
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center, DC 1526
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	IN 46285
B.5.3.4	Country	United States
B.5.6	E-mail	EU_LILLY_CLINICAL_TRIALS@lilly.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	No
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	LY900027
D.3.2	Product code	LY900027
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.3.9.3	Other descriptive name	Humalog active substance
D.3.9.4	EV Substance Code	SUB08198MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Meloxicam
D.3.9.1	CAS number	71125-38-7
D.3.9.3	Other descriptive name	MELOXICAM
D.3.9.4	EV Substance Code	SUB08726MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
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	No
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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.3.2	Product code	A10AB04
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.3.9.3	Other descriptive name	Humalog active substance
D.3.9.4	EV Substance Code	SUB08198MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
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

Type I Diabetes Mellitus

E.1.1.1

Medical condition in easily understood language

Type 1 Diabetes

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	21.1
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

To evaluate the PK response of insulin lispro when standard bolus doses of LY900027 or Humalog are administered with an insulin pump during standardized meal tests on Days 5, 7, and 10 after catheter insertion compared to baseline on Day 3.

E.2.2

Secondary objectives of the trial

To evaluate the post-prandial glucodynamics (GD) when standard bolus doses of LY900027 or Humalog are administered with an insulin pump during standardized meal tests on Days 1, 3, 5, 7, and 10 after catheter insertion.
To evaluate daily insulin requirements for up to 10 days after catheter insertion.
To evaluate the time until catheter failure
To explore safety and tolerability of LY900027.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Male or female subject with diabetes mellitus type 1 for at least 1 year.
-Age between 18 and 64 years, both inclusive.
-Body Mass Index (BMI) between 18.5 and 33.0 kg/m^2, both inclusive.
-HbA1c <= 9.0%.
-Fasting negative C-peptide (<= 0.30 nmol/L).
-Currently on stable CSII for at least 3 months prior to inclusion into the trial, with a total daily insulin dose of >0.4 and <=1.5 U/kg/day.

E.4

Principal exclusion criteria

-Previous participation in this trial. Participation is defined as randomised.
-Known allergies to adhesives, NSAIDs (e.g. Meloxicam), insulin lispro, insulin glulisine (Apidra), related compounds, or any components of the IMPs used in this trial.
-Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
-Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension).
-Symptoms of arterial hypotension
-Heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
-Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption.
-AST and/or ALT > 2 times the upper limit of normal.
-Elevated serum creatinine values above the upper limit of normal.
-More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
-Hypoglycaemic unawareness as judged by the Investigator.
-Hospitalisation for diabetic ketoacidosis during the previous 6 months.
-A positive result in the alcohol and/or urine drug screen at the screening visit.
-Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period.
-Intended use of systemic NSAIDs during the study.
-Blood donation or blood loss of more than 500 mL within the last month.
-If female, pregnancy or breast-feeding
-Women of childbearing potential who are not using a highly effective contraceptive method until 1 month after last dosing.
-Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 1 month after last dosing.

E.5 End points

E.5.1

Primary end point(s)

AUC. Ins 0-5h, area under the insulin lispro curve after bolus administration prior to an MMTTT
C Ins. max, maximum observed insulin lispro concentration

E.5.1.1

Timepoint(s) of evaluation of this end point

Days 3, 5, 7, and 10

E.5.2

Secondary end point(s)

PK Endpoints
AUCINS_0-0.5h, AUCINS_0-1h, AUCINS_0-2h, AUCINS_0-4h, AUCINS_0-5h, area under the insulin lispro curve in the indicated time intervals after bolus administration prior to an MMTTT
tmax.INS, time to maximum observed serum insulin concentration
PD Endpoints
ΔAUCPG_0-5h, incremental area under the plasma glucose curve above baseline in the indicated time intervals after bolus infusion
∆PGMAX, maximum blood glucose excursion after bolus infusion
Daily insulin requirements:
total daily insulin dose
total daily prandial insulin doses
total daily basal dose
number and total daily dose of correction bolus doses
Endpoints on Catheter Weartime
Number of of unexplained hyperglycemic episodes with PG above 250 mg/dL
Duration until catheter failure
Safety Endpoints
AEs
Hypoglycaemic episodes
Laboratory safety parameters
Physical examination
Vital signs
ECG
Local tolerability:
bolus-related infusion site pain (measured by eVAS)
3D photographs to evaluate skin reactions at catheter site before insertion and after catheter removal

E.5.2.1

Timepoint(s) of evaluation of this end point

Days 1, 3, 5, 7, and 10

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

Yes

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)

Yes

E.7.1.1

First administration to humans

Yes

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

Last visit of the last subject

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

E.8.9.2

In all countries concerned by the trial months

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.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.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. Patients will continue their previous type 1 diabetes mellitus treatment.

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

2019-12-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-12-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-07-14

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