DelfaGLP-1 Atlas

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CompletedPhase 3

A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy

Lead sponsor

Hoffmann-La Roche

Asset

Taspoglutide

Subcutaneous · GLP-1 agonist

Listed sites

210

Recruiting sites

—

Enrollment

1,072

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 IDNCT00755287
Org study IDBC20965
Secondary ID2008-001855-23

Timeline

Milestones

Study first posted2008-09-18estimated
Last update posted2016-07-29estimated
Study start2008-11 (month precision)
Primary completion2010-12actual (month precision)
Study completion2010-12actual (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 treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
•C-peptide (fasting) >=1.0ng/mL;
•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;
•symptomatic poorly controlled diabetes;
•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 (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
2
Safety / tolerability / PK
1
Other (unclassified)
1

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

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

Time frame:24 weeks

percent change from baseline, improvement

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%); incidence of hypoglycemia; change from baseline in lipid profile.

Time frame:24 weeks

descriptive

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.