DelfaGLP-1 Atlas

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CompletedPhase 3

A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea

Lead sponsor

Hoffmann-La Roche

Asset

Taspoglutide

Subcutaneous · GLP-1 agonist

Listed sites

147

Recruiting sites

—

Enrollment

756

actual

Study population

Type 2 diabetes

Key I/E criterion

•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 IDNCT00909597
Org study IDBC21893
Secondary ID2009-009157-24

Timeline

Milestones

Study first posted2009-05-28estimated
Last update posted2016-11-02estimated
Study start2009-05 (month precision)
Primary completion2010-11actual (month precision)
Study completion2010-11actual (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 mellitus;
•treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening;
•HbA1c >=7.0% and <=10% at screening;
•stable weight +/-5% for >=12 weeks prior to screening.

Exclusion criteria

•type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
•clinically significant diabetic complications;
•clinically symptomatic gastrointestinal disease;
•>3 episodes of severe hypoglycemia within 6 months before screening.

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
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint/low confidence

Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose

Time frame:weeks 24, 52 and 104

descriptive, improvement

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

Proportion of patients achieving target HbA1c <=6.5%, <=7%

Time frame:weeks 24, 52 and 104

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse events; laboratory parameters; cardiovascular events

Time frame:At each clinic visit up to 106 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.