Clinical Trials Register

Summary
EudraCT Number:	2014-000936-40
Sponsor's Protocol Code Number:	PUNiDIA-2014
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:	2014-05-06
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

2014-000936-40

A.3

Full title of the trial

pilot study to investigate the effect of e.-coli-nissle as probiotic adjuvant to antidiabetic standard care in patients with diabetic mellitus type 2

Pilotstudie zur Untersuchung der Wirkung von E.-coli-Nissle als probiotisches Adjuvans zur antidiabetischen Standardtherapie bei Patienten mit Typ-2 Diabetes mellitus

A.3.1

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

Investigation of the effect of E.-coli-Nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type 2

Untersuchung der Wirkung von E.-coli-Nissle als Unterstützung der Routinetherapie bei Patienten mit Diabetes Mellitus Typ 2

A.3.2

Name or abbreviated title of the trial where available

PUNiDIA

A.4.1

Sponsor's protocol code number

PUNiDIA-2014

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	GWT-TUD GmbH
B.1.3.4	Country	Germany
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	ARDEYPHARM GmbH
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	GWT-TUD GmbH
B.5.2	Functional name of contact point	Medical Consulting
B.5.3	Address:
B.5.3.1	Street Address	Blasewitzer Str. 43
B.5.3.2	Town/ city	Dresden
B.5.3.3	Post code	01307
B.5.3.4	Country	Germany
B.5.4	Telephone number	0049035125933100
B.5.5	Fax number	004935125933111
B.5.6	E-mail	medical.consulting@gwtonline.de

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	Mutaflor
D.2.1.1.2	Name of the Marketing Authorisation holder	ARDEYPHARM GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Mutaflor
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	Yes
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	ESCHERICHIA COLI NISSLE 1917
D.3.9.3	Other descriptive name	ESCHERICHIA COLI STRAIN NISSLE 1917
D.3.9.4	EV Substance Code	SUB76233
D.3.10	Strength
D.3.10.1	Concentration unit	CFU/ml colony forming unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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

Diabetes mellitus type 2

Diabetes mellitus Typ 2

E.1.1.1

Medical condition in easily understood language

Diabetes type 2

Diabetes Typ 2

E.1.1.2

Therapeutic area

Body processes [G] - Metabolic Phenomena [G03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10067585
E.1.2	Term	Type 2 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

Decrease in HbA1c levels within baseline and end of treatment

Senkung des HbA1c zwischen Baseline und End of treatment

E.2.2

Secondary objectives of the trial

-change in insulin resistance/secretion
- change in lipid parameters
- change in parameters of oxidative stress
- change in parameters of inflammation
- change in gastrointestinal condition
- tolerance of therapy

-Änderung der Insulinresistenz/sekretion
-Änderung der Lipidparameter
-Änderung des oxidativen Stresses
-Änderung des Entzündungsstatus
-Änderung der subjektiven gastrointestinalen Befindlichkeit
-Verträglichkeit der Behandlung

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Diabetes mellitus type 2
- HbA1c >7% (stable for 6 months)
- oral antidiabetic therapie for 6 months with Metformin, Vildagliptin, Gliniden or without Oral antidiabetic medication
- age between 45 and 80 years

-Manifester Typ-2 Diabetes mellitus; HbA1c > 7% (53 mmol/mol), ≤ 8,5% (69,4 mmol/mol)
-HbA1c 6 Monate stabil (Schwankung < ± 0,5%)
-Stabile orale antidiabetische Therapie mindestens 6 Monaten mit Metformin, Vildagliptin, Gliniden oder ohne orale Antidiabetika
-Männer und Frauen im Alter von 45 bis <80 Jahre

E.4

Principal exclusion criteria

-Myocardial infarction or stroke within the last 5 years
- insulin therapy
-Therapy with arcabose
-Acute periphere arterial disease within the last 12 months
-Insable metabolic situation
-Uncontrolled hypertension
-Body-Mass-Index ≥ 35 kg/m²
-Smokers
-Daily consumption of probiotic food
-Malignant disease within the last 5 years
-Status post transplantation
-Immunosuppressive therapy within the last 3 months
-Therapy with antibiotics
-Macroalbuminuria
-Severe liver disease

-Anamnese für Myokardinfarkt oder Schlaganfall vor <5 Jahren
-Insulintherapie
-Therapie mit Acarbose
-akute periphere arterielle Verschlusskrankheit innerhalb der letzten 12 Monate
-Instabile metabolische Situation
-Unkontrollierte Hypertonie (RR > 180/100 mmHg)
-Body-Mass-Index ≥ 35 kg/m²
-Aktuelles Rauchen
-Täglicher Genuss probiotischer Lebensmittel
-Maligne Erkrankungen innerhalb der letzten 5 Jahre
-Zustand nach Transplantation
-Immunsuppressive Therapie innerhalb der letzten 3 Monate
-Aktuelle Antibiotikatherapie
-Makroalbuminurie
-Schwere Leberstörungen (-GT und/oder ALAT > 2 µmol/L×s)

E.5 End points

E.5.1

Primary end point(s)

Decrease in HbA1c levels within baseline and end of treatment

Senkung des HbA1c zwischen Baseline und End of treatment

E.5.1.1

Timepoint(s) of evaluation of this end point

for patients: 26 weeks (2 weeks screening phase + 24 weeks treatment phase)

for trial: 12 months

for patients: 26 Wochen ( 2 Wochen Screeningphase + 24 Wochen Behandlungsphase)

für Gesamtstudie: 12 Monate

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

for patients: 26 weeks (2 weeks screening phase + 24 weeks treatment phase)

for trial: 12 months

for patients: 26 Wochen ( 2 Wochen Screeningphase + 24 Wochen Behandlungsphase)

für Gesamtstudie: 12 Monate

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

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

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

E.8.1.1

Randomised

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

Yes

E.8.1.7.1

Other trial design description

Pilotstudie

pilot study

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

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

letzte Visite des letzten Patienten

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

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

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)

standard care

Standardtherapie

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

2014-06-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-12-15

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