CompletedPhase 2

A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.

A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Lead sponsor

Hoffmann-La Roche

Asset

Taspoglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

133

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 7-9.5%

Primary endpoint

•Discontinuation due to AE

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00460941

Org study IDBC20728

Timeline

Milestones

Study first posted2007-04-17estimated

Last update posted2016-11-02estimated

Study start2007-04 (month precision)

Primary completion2008-01actual (month precision)

Study completion2008-01actual (month precision)

Assets

Investigational agents

Taspoglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;

•type 2 diabetes mellitus, with stable metformin treatment for >=3 months;

•HbA1c >=7.0% and <=9.5% at screening;

•stable weight +/-10% for >=3 months before screening.

Exclusion criteria

•type 1 diabetes mellitus;

•clinically significant gastrointestinal disease;

•treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;

•use of weight-lowering medications in the last 3 months;

•uncontrolled hypertension;

•previous exposure to GLP-1 or GLP-1 analogues.

Endpoints (2)

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

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Percentage of patients withdrawn because of gastrointestinal effects

Time frame:Week 9

Discontinuation due to AE

threshold achievement, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Mean changes in 24h blood glucose Area Under the Curve (AUC), Fasting Plasma Glucose (FPG), fructosamine, Hemoglobin A1c (HbA1c), body weight, Adverse Events (AEs), laboratory parameters.

Time frame:Week 9

change from baseline, descriptive

componentsPostprandial glucose, Fasting glucose, change, HbA1c, change, Body weight, absolute change (kg), Treatment-emergent AEs (any)

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

Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study.
Diabetic medicine : a journal of the British Diabetic Association2010 May (month)PMID20536952doi:10.1111/j.1464-5491.2010.02990.xvia clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.