GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.

Lead sponsor

Hoffmann-La Roche

Asset

Taspoglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

305

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 30-50•HbA1c 6.5-9.5%

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 IDNCT00823992

Org study IDBC22092

Secondary ID2008-005809-20

Timeline

Milestones

Study first posted2009-01-16estimated

Last update posted2016-07-28estimated

Study start2009-01 (month precision)

Primary completion2010-05actual (month precision)

Study completion2010-05actual (month precision)

Assets

Investigational agents

Taspoglutide

Study populations

Who this study enrolls

Obesity / overweightType 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, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks;

•HbA1c >=6.5% and <=9.5% at screening;

•BMI >=30 and <=50 kg/m2 at screening;

•stable weight +/-5% for at least 12 weeks prior to screening.

Exclusion criteria

•history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;

•evidence of clinically significant diabetic complications;

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

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

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change from baseline in body weight;% of patients achieving >=5% weight loss

Time frame:24 weeks

composite event, improvement

componentsBody weight, absolute change (kg), ≥5% weight-loss responders

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Absolute change from baseline in HbA1c

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

% of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function

Time frame:24 weeks

descriptive, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

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

Time frame:At planned clinic visits, for 12 months

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.