Clinical Trials Register

Summary
EudraCT Number:	2021-005892-38
Sponsor's Protocol Code Number:	I8H-MC-BDCY
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-08-26
Trial 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

Poland - Office for Medicinal Products

A.2

EudraCT number

2021-005892-38

A.3

Full title of the trial

A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared with Insulin Degludec in Participants with Type 1 Diabetes Treated with Multiple Daily Injection Therapy

Wieloośrodkowe, otwarte, randomizowane badanie fazy III prowadzone w grupach równoległych w celu oceny skuteczności i bezpieczeństwa stosowania LY3209590 jako podawanej raz w tygodniu insuliny podstawowej w porównaniu z insuliną degludec u pacjentów z cukrzycą typu 1 aktualnie leczonych metodą codziennych, wielokrotnych wstrzyknięć.

A.3.1

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

Efficacy and Safety of LY3209590 Compared with Insulin Degludec in Participants with Type 1 Diabetes Treated with Multiple Daily Injection Therapy

Skuteczność i bezpieczeństwo stosowania LY3209590 w porównaniu z insuliną degludec u pacjentów z cukrzycą typu 1 leczonych metodą codziennych wielokrotnych wstrzyknięć

A.3.2

Name or abbreviated title of the trial where available

QWINT-5

A.4.1

Sponsor's protocol code number

I8H-MC-BDCY

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
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
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	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	LY3209590
D.3.2	Product code	LY3209590
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
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	LY3209590
D.3.9.3	Other descriptive name	LY3209590
D.3.9.4	EV Substance Code	SUB183882
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	500
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	Yes
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.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	Tresiba Flextouch
D.2.1.1.2	Name of the Marketing Authorisation holder	Novo Nordisk A/S
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.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
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 DEGLUDEC
D.3.9.1	CAS number	844439-96-9
D.3.9.4	EV Substance Code	SUB96394
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	Yes
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, Type 1

E.1.1.1

Medical condition in easily understood language

Diabetes Mellitus, Type 1

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	10027433 - Metabolism and nutrition disorders

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 demonstrate that LY3209590 is noninferior to insulin degludec for the treatment of T1D in adults

Cel główny: Wykazanie, że LY3209590 nie ustępuje insulinie degludec w leczeniu cukrzycy typu 1 u dorosłych

E.2.2

Secondary objectives of the trial

To demonstrate superiority of LY3209590 to insulin degludec

Cele drugorzędowe: Wykazanie przewagi LY3209590 nad insuliną degludec

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Must be at least 18 years of age at screening, or older per local regulations;
Have a clinical diagnosis of T1D for at least 1 year prior to screening;
Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening;
Have a body mass index of ≤35 kg/m2;
Have received treatment with basal-bolus insulin analogue MDI therapy according to the local product label for at least 90 days prior to screening:
Allowed basal insulin analogues (includes biosimilars):
- insulin glargine U-100
- insulin glargine U-300
- insulin degludec U-100 or U-200, or
- insulin detemir
Allowed bolus insulin analogues (includes biosimilars):
- insulin lispro U-100 or U-200
- insulin aspart
- insulin glulisine
- fast acting insulin aspart (Fiasp® [Novo Nordisk A/S., Bagsvaerd, Denmark]), or
- insulin lispro-aabc U-100 or U-200 (Lyumjev ™ [Eli Lilly and Co., Indianapolis, IN]).

Wymagany jest wiek co najmniej 18 lat w czasie oceny przesiewowej (lub starszy zgodnie z lokalnymi przepisami);
Rozpoznanie kliniczne cukrzycy typu 1 ustalone co najmniej 1 rok przed oceną przesiewową; Wartość HbA1c wynosząca od 7,0% do 10,0% włącznie, według oznaczeń wykonanych w laboratorium centralnym w czasie oceny przesiewowej;
Wskaźnik masy ciała wynoszący ≤35 kg/m2;
Stosowanie wcześniej leczenia analogiem insuliny podawanym w kilku wstrzyknięciach w ciągu dnia (MDI) wg schematu basal-bolus zgodnie z miejscowym oznakowaniem produktu przez co najmniej 90 dni przed oceną przesiewową:
Dozwolone analogi insuliny podstawowej (w tym produkty biopodobne):
insulina glargine U100
insulina glargine U300
insulina degludec U100 lub U200, albo
insulina detemir

Dozwolone analogi insuliny bolusowej (w tym produkty biopodobne):
insulina lispro U100 lub U200
insulina aspart
insulina glulizynowa
szybko działająca insulina aspart (Fiasp®
[Novo Nordisk A/S., Bagsvaerd, Dania]), lub
insulina lispro-aabc U100 lub U200 (Lyumjev ™
[Eli Lilly and Co., Indianapolis, IN])

E.4

Principal exclusion criteria

Have a diagnosis of T2D, latent autoimmune diabetes, or specific types of diabetes other than T1D
Have a history of more than 1 episode of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening
Have hypoglycemia unawareness, in the opinion of the investigator
Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening
Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions within 90 days prior to screening
- acute myocardial infarction
- cerebrovascular accident (stroke), or
- coronary bypass surgery;
Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs of symptoms of any other liver disease, except nonalcoholic fatty liver disease, or have elevated liver enzyme measurements as determined by the central laboratory at screening:
- total bilirubin >2x ULN except for participants with Gilbert’s syndrome
- ALT or serum glutamic pyruvic transaminase >3x ULN
- AST or serum glutamic oxaloacetic transaminase >3x ULN, or
- ALP >2.5x ULN
Have a history of renal transplantation, are currently receiving renal dialysis, or have an eGFR <30 mL/min/1.73m2
Have a history of an active or untreated malignancy.

Rozpoznanie cukrzycy typu 2, utajonej cukrzycy autoimmunologicznej lub określonego typu cukrzycy innego niż typ 1
Wystąpienie w okresie 6 miesięcy przed oceną przesiewową więcej niż 1 epizodu ciężkiej hipoglikemii (zdefiniowanej jako hipoglikemia wymagająca pomocy ze względu na objawy neurologiczne);
Brak świadomości hipoglikemii według opinii badacza; Wystąpienie więcej niż 1 epizodu cukrzycowej kwasicy ketonowej lub stanu hiperosmolarnego, albo śpiączki hiperosmolarnej wymagających hospitalizacji w okresie 6 miesięcy przed oceną przesiewową;
Wystąpienie w okresie 90 dni przed oceną przesiewową niewydolności serca klasy IV według klasyfikacji Nowojorskiego Towarzystwa Kardiologicznego (NYHA) lub któregokolwiek z następujących zaburzeń sercowo-naczyniowych:
-ostry zawał mięśnia sercowego
-incydent naczyniowo-mózgowy (udar mózgu) lub
-zabieg pomostowania aortalno-wieńcowego (CABG);
Ostre lub przewlekłe zapalenie wątroby, marskość wątroby bądź wyraźne kliniczne objawy podmiotowe lub przedmiotowe jakiejkolwiek innej choroby wątroby z wyjątkiem niealkoholowej choroby stłuszczeniowej wątroby, albo następujące podwyższone wyniki badań aktywności enzymów wątrobowych według oznaczeń wykonywanych w centralnym laboratorium w czasie oceny przesiewowej:
-stężenie bilirubiny całkowitej >2 x GGN (poza uczestnikami z zespołem Gilberta)
-aktywność AlAT lub aminotransferazy glutaminowo-pirogronowej w surowicy >3 x GGN
-aktywność AspAT lub aminotransferazy glutaminowo-szczawiooctowej w surowicy >3 x GGN, albo
-ALP >2,5 x GGN

Stan po operacji przeszczepienia nerki, aktualnie stosowana dializoterapia lub eGFR <30 ml/min/1,73m2;
Czynna bądź nieleczona choroba nowotworowa w wywiadzie.

E.5 End points

E.5.1

Primary end point(s)

Change in HbA1c from baseline

Zmiana wartości HbA1c względem poziomu wyjściowego

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 26

Tydzień 26

E.5.2

Secondary end point(s)

-Change in HbA1c from baseline to Week 26;
-Time in glucose range between 70 and 180 mg/dL (3.9-10.0 mmol/L) inclusive, measured by CGM 4 weeks prior to Week 26;
-Event rate of participant-reported clinically significant nocturnal hypoglycaemia (<54 mg/dL [3.0 mmol/L] or severe) during treatment phase up to Week 52.

- Zmiana wartości HbA1c w okresie od punktu wyjścia do 26. tygodnia;
- Długość czasu utrzymywania się stężenia glukozy w zakresie 70-180 mg/dl (3,9-10,0 mmol/l) włącznie, oceniana na podstawie wyników ciągłego monitorowania glikemii (CGM) 4 tygodnie przed tygodniem 26;
- Częstość występowania zgłaszanych przez uczestników przypadków klinicznie istotnej hipoglikemii nocnej (hipoglikemia <54 mg/dl [3,0 mmol/l] lub ciężka) w okresie leczenia aż do tygodnia 52.

E.5.2.1

Timepoint(s) of evaluation of this end point

-Week 26
-Week 52

-Tydzień 26
-Tydzień 52

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

Yes

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)

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Taiwan

India

Japan

United States

E.8.7

Trial has a data monitoring committee

Yes

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

603

F.1.3

Elderly (>=65 years)

Yes

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

115

F.4.2

For a multinational trial

F.4.2.1

In the EEA

143

F.4.2.2

In the whole clinical trial

670

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)

The sponsor will not provide participants with ongoing supplies of study medication after they have completed the study treatment period or permanently discontinued the study IP.

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

2022-09-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-08-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-05-07

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IMP with orphan designation in the indication
Orphan Designation Number:
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