Clinical Trials Register

Summary
EudraCT Number:	2017-000349-30
Sponsor's Protocol Code Number:	NL60669
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-06-27
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

Netherlands - Competent Authority

A.2

EudraCT number

2017-000349-30

A.3

Full title of the trial

Effect of INtervention with DMR, GLP-1 and lifestyle intensification -in Subjects with insulin dePendent type 2 diabetes- on Insulin Requirement and mEtabolic parameters

Effect van interventie met DMR, GLP-1 en lifestyle intensivering -bij patiënten met insulineafhankelijke type 2 diabetes- op insulinebehoefte en metabole parameters

A.3.1

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

Effect of INtervention with DMR, GLP-1 and lifestyle intensification -in Subjects with insulin dePendent type 2 diabetes- on Insulin Requirement and mEtabolic parameters

Effect van interventie met DMR, GLP-1 en lifestyle intensivering -bij patiënten met insulineafhankelijke type 2 diabetes- op insulinebehoefte en metabole parameters

A.3.2

Name or abbreviated title of the trial where available

INSPIRE study

INPIRE studie

A.4.1

Sponsor's protocol code number

NL60669

A.5.4

Other Identifiers

Name:

ABR nummer

Number:

NL60669

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	Academic Medical Center
B.1.3.4	Country	Netherlands
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	Fractyl Laboraties Inc.
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	Academic Medical Center
B.5.2	Functional name of contact point	Annieke van Baar
B.5.3	Address:
B.5.3.1	Street Address	Meibergdreef 9
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1105AZ
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31205661613
B.5.5	Fax number	+31205669156
B.5.6	E-mail	a.c.vanbaar@amc.nl

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	Victoza (Liraglutide)
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	Netherlands
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	Victoza
D.3.2	Product code	EMA/354054/2016
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	Intradermal use
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 2 diabetes mellitus

Diabetes mellitus type 2

E.1.1.1

Medical condition in easily understood language

Type 2 diabetes

Suikerziekte type 2

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

MedDRA Classification

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 main objective of this pilot study is to evaluate the efficacy of the Duodenal Mucosal Resurfacing procedure combined with GLP-1 administration and lifestyle intervention in subjects with insulindependent type 2 diabetes. Study success is defined as insulin independence at 6 months after DMR with an HbA1c level of ≤ 7.5%.

E.2.2

Secondary objectives of the trial

The second objective of this pilot study is to identify cardiovascular, metabolic and hepatic health benefits accompanied by this changed treatment strategy. The results of this pilot study will be used to estimate an effect size of this combined treatment in previously insulin dependent subjects. This effect size will be used for an adequate sample size calculation for a subsequent randomized controlled trial.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. 28 -75 years of age
2. Treatment with long acting insulin ≤ 2 years
3. On daily long acting insulin dose ≤ 1 U/kg
4. BMI ≥ 24 and ≤ 40 kg/m2
5. HbA1c ≤ 8.0% (64 mmol/mol)
6. Fasting C-peptide ≥ 500 pmol/L (1.5 ng/ml)
7. Willing to comply with study requirements and able to understand and comply with informed consent
8. Willing to sign an informed consent form

E.4

Principal exclusion criteria

1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
2. Fasting C-peptide < 500 pmol/L (1.5 ng/ml)
3. Current use of multiple daily doses insulin or insulin pump
4. Current use of a sulfonylurea derivate or meglitinide
5. Known autoimmune disease, as evidenced by a positive Anti-GAD test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
6. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
7. History of chronic or acute pancreatitis
8. Known active hepatitis or active liver disease
9. Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn’s Disease and Celiac Disease
10. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
11. Use of anticoagulation therapy (such as phenprocoumon and acenocoumarol) and novel oral anticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran) which cannot be discontinued for 7 days before and 14 days after the procedure
12. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed.
13. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
14. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
15. Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
16. Persistent Anemia, defined as Hgb<10 g/dl
17. eGFR or MDRD <30 ml/min/1.73m^2
18. Active systemic infection
19. Active malignancy within the last 5 years
20. Not potential candidates for surgery or general anesthesia
21. Active illicit substance abuse or alcoholism
22. Participating in another ongoing clinical trial of an investigational drug or device
23. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation

E.5 End points

E.5.1

Primary end point(s)

Protocol driven free of insulin at 6 months including and an HbA1c ≤ 7.5%.

E.5.1.1

Timepoint(s) of evaluation of this end point

At 6 months follow-up

E.5.2

Secondary end point(s)

a. HbA1c
b. Change in HbA1c
c. Achieving target HbA1c of 7%
d. FPG
e. Change in FPG
f. Peak and AUC glucose in MMTT
g. Gut hormones in MMTT
h. Pancreatic hormones in MMTT
i. Metabolic profile from MMTT
j. HOMA IR
k. Insulin sensitivity
l. Beta cell function
m. MRFF
n. ALT and AST
o. Change in AST and ALT
p. Fibrosis-4 (FIB-4) score
q. Change in FIB-4 score
r. Urine microalbumin
s. Blood pressure
t. DEXA body scan

E.5.2.1

Timepoint(s) of evaluation of this end point

At 3 (if applicable) and 6 months follow-up

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

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)

Yes

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

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.8.3

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

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

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

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)

Normal care for type 2 diabetes by subjets' own general practicioner.

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

2017-06-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-08-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-12-16

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