Clinical Trials Register

Summary
EudraCT Number:	2012-005505-51
Sponsor's Protocol Code Number:	DPIDM-2012-01
National Competent Authority:	Ireland - HPRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-02-15
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

Ireland - HPRA

A.2

EudraCT number

2012-005505-51

A.3

Full title of the trial

Dipeptidyl peptidase-4 Inhibition in Psoriasis patients with diabetes (DIP): A Randomized Clinical Trial.

A.3.1

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

A study to investigate whether a drug called Januvia, that is licensed to lower blood glucose in diabetic patients, has an effect on psoriasis.

A.4.1

Sponsor's protocol code number

DPIDM-2012-01

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	University College Dublin
B.1.3.4	Country	Ireland
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	St Vincent’s University Hospital Department of Dermatology
B.4.2	Country	Ireland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	UCD Clinical Research Centre, St Vincent's University Hospital
B.5.2	Functional name of contact point	Tomas Ahern
B.5.3	Address:
B.5.3.1	Street Address	Elm Park
B.5.3.2	Town/ city	Dublin
B.5.3.3	Post code	4
B.5.3.4	Country	Ireland
B.5.4	Telephone number	353873580487
B.5.5	Fax number	35312214981
B.5.6	E-mail	tomasbahern@physicians.ie

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	Januvia
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Ltd
D.2.1.2	Country which granted the Marketing Authorisation	Ireland
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	Sitaglitpin
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SITAGLIPTIN
D.3.9.1	CAS number	790712-60-6
D.3.9.4	EV Substance Code	SUB25227
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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)	No
	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	Diamicron
D.2.1.1.2	Name of the Marketing Authorisation holder	Les Laboratoires Servier
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Gliclazide
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GLICLAZIDE
D.3.9.1	CAS number	21187-98-4
D.3.9.4	EV Substance Code	SUB07921MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
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)	No
	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Psoriasis

E.1.1.1

Medical condition in easily understood language

Psoriasis is a common and chronic skin disease. A person with psoriasis generally has patches of raised red skin with thick silvery scales.

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10037153
E.1.2	Term	Psoriasis
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue 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 the research project is to determine the change in the psoriasis area and severity index (ΔPASI) during 16 weeks of treatment with a dipeptidyl peptidase-4 inhibitor (Januvia®, 100mg daily) in psoriasis patients with type 2 diabetes. This will be compared to the ΔPASI in psoriasis patients with type 2 diabetes during 16 weeks of treatment with a comparator (Diamicron®, 80mg to 320mg daily).

E.2.2

Secondary objectives of the trial

To determine, and compare, the effects of:
1.16 weeks tmt with Januvia® with Diamicron® on the:
a.Incidence of AEs and d/c of one of the IMPs
b.Change in QOL scores
c.Incidence of achievement of > than 50% reduction in PASI from baseline
d.Incidence of PASI-75 & PASI-90
e.Time to achieve PASI-50, PASI-75 & PASI-90
f.Changes in levels of CVD risk factors
g.Changes in serum concentrations of cytokines and hormones
h.Changes in mononuclear cell expression of immune proteins
2. 32 weeks tmt with Januvia® with 16 weeks Diamicron® followed by 16 weeks Januvia® tmt on the:
a.Change in PASI
b.Incidence of AEs and d/c of one of the IMPs
c.Change in QOL scores
d.Incidence of achievement > than 50% reduction in PASI from baseline
e.Incidence of PASI-75 & PASI-90
f.Time to achieve PASI-50, PASI-75 & PASI-90
g.Changes in levels of CVD risk factors
h.Changes in serum concentrations of cytokines and hormones
j.Changes in mononuclear cell expression of immune proteins

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

People who satisfy all of the following may be included in the study:
1. Have a diagnosis of generalized chronic plaque and/or guttate psoriasis;
2. Are male or female aged between 18 and 75 years inclusive;
3. Have a psoriasis area and severity index (PASI) greater than 7 at screening or baseline;
4. Have a diagnosis of type 2 diabetes;
5. Have a glycated haemoglobin (HbA1c) level between 48mmol/mol and 80mmol/mol;
6. Are able and willing to stop sulphonylurea, dipeptidyl peptidase-4 [DPP-4] inhibitor and glucagon-like peptide-1 [GLP-1] analogue therapy for the duration of the study;
7. Have a negative pregnancy test at screening (women of child bearing potential only); and
8. Are willing to voluntarily sign a statement of informed consent to participate in the study.

E.4

Principal exclusion criteria

People with any of the following conditions will be excluded from the study:
1. Allergy or hypersensitivity to Januvia® or Diamicron®;
2. Current or recent (within 8 weeks) receipt of phototherapy;
3. Type 1 diabetes;
4. Severe kidney disease, as defined as an estimated glomerular filtration rate of less than <15ml/min/1.73 m2;
5. Severe heart or liver disease;
6. Any other contraindications, as stated in the SPCs for Januvia® or Diamicron®;
7. Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception or abstinence during participation in the study;
8. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial;
9. Previous randomisation into this study;
10. Concurrent participation in another clinical trial; and
11. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit).

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint of the study is the change in the psoriasis area and severity index in psoriasis patients with type 2 diabetes after sixteen weeks of treatment.

E.5.1.1

Timepoint(s) of evaluation of this end point

After a 16 week treatment period

E.5.2

Secondary end point(s)

The secondary efficacy endpoints are:
1. Change in psoriasis area and severity index after 32 weeks of treatment;
2. Incidence of adverse events within 16 and 32 weeks of treatment commencement;
3. Incidence of discontinuation of one of the study investigational medicinal products (IMPs) within 16 and 32 weeks of treatment commencement;
4. Changes in validated quality of life scores (DLQI, EQ-5D, HADS, and HAQ-8) after 16 and 32 weeks;
5. Proportion of patients who achieve a greater than 50% reduction in PASI from baseline (PASI-50) within 16 and 32 weeks;
6. Proportion of participants who achieve PASI-75 and PASI-90 within 16 and 32 weeks;
7. Times taken to achievement of PASI-50, PASI-75 and PASI-90;
8. Changes in levels of cardiovascular disease risk factors (blood pressure, glycaemic measures lipid fractions, weight etc) after 16 and 32 weeks;
9. Changes in serum concentrations of cytokines (CRP, IL-6, TNFα, IL-1β, IL-10 etc) after 16 and 32 weeks;
10. Changes in serum concentrations of hormones (GLP-1, PYY etc) after 16 and 32 weeks; and
11. Changes in peripheral blood mononuclear cell expression of immune proteins (IL-6, TNFα, IL-10, IL-27, IFNγ, IL-17, TLR-4, TLR-2, JNK-1 MCP-1 etc) after 16 and 32 weeks.

E.5.2.1

Timepoint(s) of evaluation of this end point

After 16 and 32 weeks treatment.

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

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

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

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

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

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

The definition of the end of this trial is the last visit of the last subject undergoing the trial.

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)

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

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)

The research participants involvement in this study will end following the completion of the End of Study Visit (or early withdrawal visit if
applicable). Once participants have completed their involvement in this study they will be provided with standard treatment by their usual
healthcare providers.

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

2013-03-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-01

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-01-15

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