Clinical Trials Register

Summary
EudraCT Number:	2008-003575-47
Sponsor's Protocol Code Number:	BP21572
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:	2008-09-26
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2008-003575-47

A.3

Full title of the trial

A randomized, double-blind, placebo controlled, parallel group study to investigate the effect of Taspoglutide on gastric emptying measured by a paracetamol test after single dose and after multiple doses in patients with Type 2 diabetes

A.3.2

Name or abbreviated title of the trial where available

Gastric Emptying Study

A.4.1

Sponsor's protocol code number

BP21572

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	F. Hoffmann-La Roche Ltd
B.1.3.4	Country	Switzerland
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Taspoglutide
D.3.2	Product code	RO5073031
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Taspoglutide
D.3.9.1	CAS number	275371-94-3
D.3.9.2	Current sponsor code	RO5073031/F04-04
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	10
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	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	Taspoglutide
D.3.2	Product code	RO5073031
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Taspoglutide
D.3.9.1	CAS number	275371-94-3
D.3.9.2	Current sponsor code	RO5073031/F04-01
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	20
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with Type 2 diabetes

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10012601
E.1.2	Term	Diabetes mellitus

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 evaluate the effect of taspoglutide on gastric emptying (as assessed by the pharmacokinetics of paracetamol) after first and multiple dose of taspoglutide.

E.2.2

Secondary objectives of the trial

– To explore the relationship between plasma taspoglutide concentrations and gastric emptying (as measured by the pharmacokinetics of paracetamol).
– To assess the safety and tolerability of taspoglutide and placebo (diluent).
– To assess the effect of taspoglutide on renal function parameters after single and multiple dose of taspoglutide.
– To assess the multiple dose pharmacokinetics of taspoglutide.
– To assess the effect of taspoglutide on fasting plasma glucose and HbA1c.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or Female subject, 18 through 75 years of age, inclusive.
2. Type 2 diabetes mellitus patient.
• Fasting plasma glucose ≤ 240 mg/dL (13.3 mmol/L) at screening.
• HbA1c ≤ 9.5% at screening.
•Patients treated with acceptable (not excluded) stable oral antidiabetic drug therapy for at least 3 months prior to screening
3. Subject must have a Body Mass Index (BMI) > 25 kg/ m2 and ≤ 45 kg/m2 at screening.
4. Stable weight ± 10% for at least 3 months before screening.
5. Female subject must be either postmenopausal (at least one year after the cessation of menses and confirmed by FSH > 50 UI/L or postmenopausal for more than 1 year (2 years after the cessation of menses)) or surgically sterilized (by means of hysterectomy, bilateral oophorectomies or tubal ligations) or if of childbearing potential use two medically approved birth control methods (e.g. hormonal contraceptives, IUD, barrier contraception) and be willing to use the same method of contraception during the whole course of the study and for at least 3 months after the last dose.
6. Patients able to participate and to comply with the study restrictions and have given written informed consent.

E.4

Principal exclusion criteria

1. Type 1 diabetes mellitus.
2. Acute gastrointestinal symptoms at the time of screening and/or Day -1 (e.g. nausea, vomiting, diarrhea, heartburn).
3. Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases (except autonomic and/ or sensomotoric neuropathy) inclusive history of chronic pancreatitis or idiopathic acute pancreatitis.
4. Serious illness, such as active cancer, major active infection or known inflammatory process, severe psychiatric disorders at the time of the screening examination.
5. Clinically significant GI disease including but not limited to inflammatory bowel disease, irritable bowel syndrome, celiac disease, dyspepsia or surgery of the gastrointestinal tract (except appendectomy/cholecystectomy) and history of gastric bypass or antrectomy or small bowel resection.
6. History of ketoacidosis or lactic acidosis.
7. History of unstable hypertension (SBP > 170 mmHg and/or DBP > 105 mmHg), within the past 12 weeks prior to screening.
8. Known proliferative diabetic retinopathy.
9. Known hemoglobinopathy or chronic anemias.
10. Renal disease or renal dysfunction (as suggested by serum creatinine ≥ 132 µmol/L (1.5 mg/dL) males, ≥ 123 µmol/L (1.4 mg/dL) females at screening.
11. Clinically relevant QTc prolongation (e.g. QTc > 450 ms), family history of Long QT Syndrome, or concomitant use of Class I antiarrhythmic drugs (e.g. disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone).
12. Any clinically relevant abnormal laboratory test results or ECG (including positive test results for drugs of abuse and alcohol test) prior to first dosing, which precludes safe involvement in the study as judged by the investigator.
13. Impaired liver function (ALT or AST > 3 x ULN) at screening.
14. Subjects who test positive for HIV I and II, Hepatitis B or Hepatitis C.
15. Pregnant or lactating women.
16. History of active substance abuse (including alcohol) within the past 2 years.
17. Alcohol consumption of more than 21 or 18 units (1 unit = 10 mL of pure alcohol [UK unit]) per week for males and females respectively, or a history of alcoholism.
18. Smoking of more than 15 cigarettes a day or the equivalent amount of tobacco.
19. Treatment with exenatide or exendin analogues, GLP-1 or GLP-1 analogues at anytime during the past.
20. Treatment with weight lowering agents (e.g. orlistat, sibutramine, rimonabant, phentermine) during the last 12 weeks prior to screening.
21. Current sulfonylurea antidiabetics, acarbose, DPPIV-inhibitors.
22. Treatment with any additional oral anti-diabetic medication apart from the stable therapy (see inclusion criteria 2) and/or herbal/over the counter preparations that may affect glycemic control within 12 weeks prior to screening.
23. Treatment with insulin for more than one week within 6 months prior to screening.
24. Subjects who use drugs (including herbal drugs) known to affect gastrointestinal motility within two weeks before the first drug administration (e.g. prokinetics such as domperidone and metoclopramide, anticholinergics such as scopolamine etc.)
25. Corticosteroid treatment (>7 consecutive days of treatment) within 4 weeks prior to screening.
26. Treatment with thyroid hormones within which are not on a stable dose for at least 12 weeks prior to screening.
27. Known hypersensitivity to taspoglutide or any of the components of its formulation.
28. Participation in an investigational drug study within 60 days (or five half-lives, whichever is longer) prior to screening.
29. Blood loss or donation of more than 500 mL in the 3 months prior to screening.
30. Vulnerable subjects (e.g. persons kept in detention)

E.5 End points

E.5.1

Primary end point(s)

Tmax, log(AUC0-∞) and log(Cmax) of paracetamol

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

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

Yes

E.6.13.1

Other scope of the trial description

renal funtion, BSR (biomarker sample repository)

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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 months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-09-26.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	30
F.4.2	For a multinational trial
F.4.2.1	In the EEA	60
F.4.2.2	In the whole clinical trial	60

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

2008-10-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-07-27

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials