Clinical Trials Register

Summary
EudraCT Number:	2011-000842-39
Sponsor's Protocol Code Number:	I2R-MC-BIAJ
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-11-14
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-000842-39

A.3

Full title of the trial

A Comparison of LY2605541 versus Insulin Glargine as Basal Insulin Treatment in Combination with Oral Anti-Hyperglycemia Medications in Insulin-Naïve Patients with Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study The IMAGINE 2 Study

Confronto di LY2605541 verso Insulina Glargine come terapia basale in combinazione con farmaci antidiabetici orali in pazienti di tipo 2 che iniziano una terapia con insulina: studio in doppio cieco e randomizzato

A.3.1

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

A Study in Type 2 Diabetes

Studio su pazienti diabetici di tipo 2

A.3.2

Name or abbreviated title of the trial where available

IMAGINE 2

A.4.1

Sponsor's protocol code number

I2R-MC-BIAJ

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
B.1.3.4	Country	Italy
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	Boehringer Ingelheim
B.4.2	Country	Germany
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 Information
B.5.3	Address:
B.5.3.1	Street Address	Via Gramsci 731
B.5.3.2	Town/ city	Sesto Fiorentino
B.5.3.3	Post code	50019
B.5.3.4	Country	Italy
B.5.4	Telephone number	0554257050
B.5.5	Fax number	0554257348
B.5.6	E-mail	eu_lilly_clinicl_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	Insulin Basal Lispro
D.3.2	Product code	LY2605541
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.3.9.2	Current sponsor code	LY2605541
D.3.9.3	Other descriptive name	Insulin Basal Lispro
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	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	LANTUS*SC 10FL 100UI/ML 5ML
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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
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.3.9.1	CAS number	160337-95-1
D.3.9.2	Current sponsor code	LANTUS
D.3.9.3	Other descriptive name	Insulin Glargine
D.3.9.4	EV Substance Code	SUB08196MIG
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	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.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 2 Diabetes

Diabete di Tipo 2

E.1.1.1

Medical condition in easily understood language

Diabetes

Diabete

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10049746
E.1.2	Term	Insulin-requiring type II 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

The primary objective of this study is to demonstrate that LY2605541 is noninferior to insulin glargine for the change in HbA1c from baseline to 26 weeks of treatment in insulin naive patients with T2DM

L'obiettivo primario di questo studio è di dimostrare che LY2605541 non è inferiore a insulina glargine per la variazione di HbA1c dal basale alla 26 settimanae di trattamento nei pazienti insulino-naive con diabete di tipo 2

E.2.2

Secondary objectives of the trial

Gated: 1. Nocturnal hypoglycemia rate during the first 26 weeks of treatment 2. Proportion of patients with HbA1c <7.0% at 26 weeks and no nocturnal hypoglycemia during the first 26 weeks of treatment 3. HbA1c change from baseline after 26 weeks of treatment 4. Proportion of patients with HbA1c <7.0% after 26 weeks of treatment 5. Total hypoglycemia rate during the first 26 weeks of treatment 6. Fasting serum glucose (FSG) by laboratory measurement after 26 weeks of treatment

1. Tasso di ipoglicemia notturna durante le prime 26 settimane di trattamento 2. Proporzione di pazienti con HbA1c <7,0% a 26 settimane e non ipoglicemia notturna durante le prime 26 settimane di trattamento 3. Cambimenti di HbA1c dal basale dopo 26 settimane di trattamento 4. Proporzione di pazienti con HbA1c <7,0% dopo 26 settimane di trattamento 5. Tasso totale di ipoglicemie durante le prime 26 settimane di trattamento 6. Glicemia a digiuno (FSG) mediante misurazione di laboratorio dopo 26 settimane di trattamento

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

PHARMACOGENETIC:
Vers:a
Date:2010/09/02
Title:Pharmacogenetic Evaluations (26 June 2011)
Objectives:Where local regulations allow, a blood sample will be collected for pharmacogenetic analysis. It is a onetime collection, as noted in the Study Schedule. Samples will be stored and analysis may be performed on genetic variants thought to play a role in glucose and insulin regulation, beta cell function, characterization of patients' responsiveness to LY2605541, or diabetes- related metabolic abnormalities.

FARMACOGENETICA:
Vers:a
Data:2010/09/02
Titolo:Valutazioni Farmacogenetiche
Obiettivi:Dove le normative locali lo consentono, un campione di sangue sarà raccolto per l' analisi farmacogenetica. E un prelievo unico come indicato nella Studio Pianificazione. I campioni saranno conservati e analizzati su varianti genetiche che si ritengono svolgere un ruolo sul metabolismo di glucosio e insulina, sulla funzione delle cellule beta, sulla caratterizzazione dei pazienti e la risposta risposta ai LY2605541, sulle anomalie metaboliche correlate al diabete

E.3

Principal inclusion criteria

T2DM (per World Health Organization [WHO] Classification of Diabetes not treated with insulin [2] Age 18 years of age or older [3] Duration of diabetes ≥ 1 year

1. Diabete di tipo 2 (per Organizzazione mondiale della sanità [Oms] 2. Età 18 anni di età o più anziani 3. Durata del diabete ≥ 1 anno

E.4

Principal exclusion criteria

Insulin therapy: have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions, and up to a maximum of 4 continuous weeks. [13] Concomitant medications: Rosiglitazone, glucagon-like peptide-1 (GLP-1) receptor agonist (for example, exenatide, exenatide onceweekly or liraglutide) used concurrently or within 3 months prior to screening. [14] Local OAM restrictions: for patients on OAMs, restrictions for cardiac, renal and hepatic diseases, local product regulations must apply [15] Prescription weight loss medications: are currently taking, or have taken within the 3 months preceding screening, prescription or over-thecounter medications to promote weight loss. [16] Severe hypoglycemia history

La terapia insulinica: hanno usato la terapia insulinica (al di fuori della gravidanza) in qualsiasi momento negli ultimi 2 anni, tranne che per trattamento a breve termine di acuta condizioni, e fino ad un massimo di 4 settimane ininterrotte. [13] I trattamenti concomitanti: Rosiglitazone, glucagone-like peptide-1 (GLP-1) agonista del recettore (ad esempio, exenatide, onceweekly exenatide o liraglutide) utilizzati contemporaneamente o entro 3 mesi prima screening. [14] Restrizioni locali OAM: per i pazienti in OAMs, restrizioni per malattie cardiache, renali ed epatiche, i regolamenti di prodotti locali devono applicare [15] Prescrizione farmaci perdita di peso: sono attualmente in corso, o hanno presa entro i 3 mesi precedenti lo screening, prescrizione o over-thecounter farmaci per promuovere la perdita di peso. [16] Storia ipoglicemia grave

E.5 End points

E.5.1

Primary end point(s)

A change of HbA1c from baseline to 26 weeks that is not inferior to glargine.

Cambio di HbA1c dal basale a 26 settimane non è inferiore a glargine.

E.5.1.1

Timepoint(s) of evaluation of this end point

26 weeks

26 settimane

E.5.2

Secondary end point(s)

Nocturnal and total hypoglycemia rates and incidences superior to glargine, proportion of patients with HbA1c <7% at 26 weeks of treatment (also HbA1c <7% with no nocturnal hypoglycemia, FPG by laboratory, FBG by SMBG, weight change from baseline, SMBG 6-pt profile, HbA1c, insulin dose, number of dose adjustments to steady state, triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, insulin and insulin analog antibodies, other safety endpoints such as serious adverse events, vitals, treatment-emergent adverse events, Health Outcomes measurements EQ-5D, ITSQ, and LBSS.

I tassi di ipoglicemia notturna e totale e l'incidenza superiore al glargine, la proporzione di pazienti con HbA1c <7% a 26 settimane di trattamento (anche HbA1c <7% senza l'ipoglicemia notturna, glicemia a digiuno da laboratorio, FBG da SMBG, cambiamenti di peso dal basale, SMBG 6 pt profilo, HbA1c, dose di insulina, il numero di aggiustamenti della dose di costante Stato, trigliceridi, colesterolo totale, colesterolo LDL, colesterolo HDL, anticorpi analogo dell'insulina e l'insulina, gli endpoint di sicurezza quali gli eventi avversi gravi, vitali, gli eventi avversi trattamento-emergenti, Risultati Salute misure EQ-5D, ITSQ e LBSS.

E.5.2.1

Timepoint(s) of evaluation of this end point

All gates objective endpoints are at 26 weeks of treatment for many of the non-gated secondary endpoints have various timepoints such as 0 to 12 weeks, 0 to 26 weeks, 0 to 52 weeks, 0 to 78 weeks, 12 to 26 weeks, 26 to 52 weeks, 52 to 78 weeks for nocturnal and total hypoglycemia incidences; 0 to 12 weeks, 0 to 52 weeks, 0 to 78 weeks, 12 to 26 weeks, 26 to 52 weeks, 52 to 78 weeks for nocturnal and total hypoglycemia rates; 52 and 78 weeks for FPG by laboratory, 52 and 78 weeks for proportion of patients with HbA1c <7%, and the same as immediately above with no nocturnal hypoglycemia, and HbA1c change from baseline

Tutti gli endpoint secondari ''GATED'' sono a 26 settimane di trattamento Per molti degli endpoint secondari non-dipendenti si hanno riferimenti temporali diversi, come da 0 a 12 settimane, da 0 a 26 settimane, da 0 a 52 settimane, da 0 a 78 settimane, da 12 a 26 settimane, 26-52 settimane, 52-78 settimane per l'ipoglicemia notturna e totale incidenza, 0 a 12 settimane, da 0 a 52 settimane, da 0 a 78 settimane, da 12 a 26 settimane, 26-52 settimane, 52-78 settimane per l'ipoglicemia notturna e totale tassi, 52 e 78 settimane per FPG da laboratorio, 52 e 78 settimane per la proporzione di pazienti con HbA1c <7%, e la stessa senza l'ipoglicemia notturna, e il cambiamento HbA1c dal basale

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

E.8.2.3.1

Comparator description

Insulina Glargine

Insulin Glargin

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

Australia

Brazil

Canada

Israel

Mexico

New Zealand

Russian Federation

South Africa

Turkey

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

Number of subjects for this age range:

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:

1137

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

379

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

638

F.4.2.2

In the whole clinical trial

1516

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 patients with ongoing supplies of study medication after they have completed the study treatment period because LY2605541 is experimental, while insulin glargine is readily available

Lo Sponsor non fornirà ai pazienti i farmaci dopo aver completato il periodo di trattamento di studio perché il farmaco LY è sperimentale, mentre l'insulina glargine è prontamente disponibile sul mercato

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

2011-12-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-01-24

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