GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.

Lead sponsor

Hoffmann-La Roche

Asset

Taspoglutide

Subcutaneous · GLP-1 agonist

Listed sites

148

Recruiting sites

—

Enrollment

666

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 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 IDNCT00754988

Org study IDBC21713

Secondary ID2008-001854-42

Timeline

Milestones

Study first posted2008-09-18estimated

Last update posted2016-11-04estimated

Study start2008-10 (month precision)

Primary completion2011-03actual (month precision)

Study completion2011-03actual (month precision)

Assets

Investigational agents

Taspoglutide

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 (>=1500mg/day) for at least 12 weeks;

•HbA1c >=7.0% and <=10.0% at screening;

•BMI >=25 (>23 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 mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;

•evidence of clinically significant diabetic complications;

•clinically symptomatic gastrointestinal disease;

•myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;

•known hemoglobinopathy or chronic anemia.

Endpoints (3)

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

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Mean changes in HbA1c

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.

Time frame:Throughout study

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; change from baseline in lipid profile; beta cell function.

Time frame:24 weeks

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.