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CompletedPhase 3

A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Hoffmann-La Roche

Assets

Exenatide / Taspoglutide

Listed sites

216

Recruiting sites

Enrollment

1,189

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI ≥25HbA1c 7-10%

Primary endpoint

HbA1c, change

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 IDNCT00717457
Org study IDBC21625
Secondary ID2008-001856-36

Timeline

Milestones

Study first posted2008-07-17estimated
Last update posted2016-11-02estimated
Study start2008-07 (month precision)
Primary completion2011-03actual (month precision)
Study completion2011-03actual (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 receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
HbA1c >=7.0% and <=10% at screening;
BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening;
stable weight +/- 5% for at least 12 weeks prior to screening.

Exclusion criteria

history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
history of acute metabolic diabetic complications within the previous 6 months;
evidence of clinically significant diabetic complications;
known proliferative diabetic retinopathy;
myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
known hemoglobinopathy or chronic anemia;
clinically significant gastrointestinal disease.

Endpoints (5)

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

Glycemic / diabetes
4
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Fasting body weight

Time frame:24 weeks

descriptive

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of patients reaching target HbA1c <=7.0%, <=6.5%

Time frame:24 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.

Time frame:24 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Beta cell function (proinsulin/insulin ratio)

Time frame:24 weeks

ratio, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.