GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 3

A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

A Multi-center, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naive 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

Recruiting sites

—

Enrollment

370

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 IDNCT01051011

Org study IDZC22565

Timeline

Milestones

Study first posted2010-01-18estimated

Last update posted2016-11-02estimated

Study start2010-01 (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 mellitus, treated with stable dose of metformin and sulfonylurea for >/= 12 weeks prior to screening

•HbA1c 7-10% at screening

•body weight stable (+/-5%) for >/= 12 weeks prior to screening

•fasting C-peptide >/=1ng/ml

•treatment-naïve for insulin

Exclusion criteria

•diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes

•acute metabolic diabetic complications or evidence of clinically significant diabetic complications

•clinically symptomatic gastrointestinal disease

•history of chronic pancreatitis or acute idiopathic pancreatitis

•>3 episodes of severe hypoglycemia within 6 months prior to screening

•miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening

•any treatment with exenatide, exendin analogues, GLP-1 or its analogues

Endpoints (5)

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/low confidence

Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)

Time frame:week 24

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Glycemic control assessed by HbA1c

Time frame:week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c

Time frame:week 24

descriptive

Secondary/protocol endpoint

Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values

Time frame:week 24

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters

Time frame:throughout study, laboratory assessments weeks 12, 24, 32 and 52

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.