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CompletedPhase 3

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

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

Lead sponsor

Hoffmann-La Roche

Asset

Taspoglutide

Subcutaneous · GLP-1 agonist

Listed sites

3

Recruiting sites

Enrollment

60

actual

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoint

Tmax, log (AUC), log(Cmax)of paracetamol

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00809705
Org study IDBP21572
Secondary ID2008-003575-47

Timeline

Milestones

Study first posted2008-12-17estimated
Last update posted2016-11-02estimated
Study start2008-12 (month precision)
Primary completion2009-10actual (month precision)
Study completion2009-10actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
3
Renal / kidney
1

Renal / kidney

1 endpoint
Secondary/protocol endpoint

renal function (creatinine clearance, urine volume and electrolytes)

Time frame:Throughout study

descriptive

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Tmax, log (AUC), log(Cmax)of paracetamol

Time frame:Days -1, 1, 5, 29, 33, 78 and 82

Tmax

concentration, descriptive

Secondary/protocol endpoint

Adverse events, laboratory parameters, vital signs

Time frame:Throughout study

descriptive

Secondary/protocol endpoint

Multiple dose pharmacokinetics of Taspoglutide

Time frame:Throughout study

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.