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A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes

NCT ID: NCT00809705

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-10-31

Brief Summary

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This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

taspoglutide

Intervention Type DRUG

10mg sc once weekly for 12 weeks

2

Group Type EXPERIMENTAL

taspoglutide

Intervention Type DRUG

10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

sc once weekly for 12 weeks

Interventions

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Placebo

sc once weekly for 12 weeks

Intervention Type DRUG

taspoglutide

10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks

Intervention Type DRUG

taspoglutide

10mg sc once weekly for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus, treated with stable oral antidiabetic drug therapy for \>=3 months prior to screening;
* stable weight +/-10% for \>=3 months before screening.

Exclusion Criteria

* type 1 diabetes mellitus;
* acute gastrointestinal symptoms at screening and/or day -1;
* clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Berlin, , Germany

Site Status

Neuss, , Germany

Site Status

London, , United Kingdom

Site Status

Countries

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Germany United Kingdom

Other Identifiers

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2008-003575-47

Identifier Type: -

Identifier Source: secondary_id

BP21572

Identifier Type: -

Identifier Source: org_study_id