GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.

A Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Lead sponsor

Hoffmann-La Roche

Asset

Taspoglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

306

actual

Study population

Type 2 diabetes

Key I/E criterion

—

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 IDNCT00423501

Org study IDBC20688

Timeline

Milestones

Study first posted2007-01-18estimated

Last update posted2016-11-02estimated

Study start2007-02 (month precision)

Primary completion2007-11actual (month precision)

Study completion2007-11actual (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, with stable metformin treatment for >=3 months;

•stable weight +/-10% for >=3 months before screening.

Exclusion criteria

•type 1 diabetes mellitus;

•treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;

•use of weight-lowering medications in the last 3 months;

•uncontrolled hypertension.

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

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Absolute change from baseline in HbAlc

Time frame:Week 8

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.

Time frame:Week 8

Fasting glucose, change

change from baseline, improvement

componentsFasting glucose, change, C-peptide AUC

LOINC 1558-6

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Changes in lipid profile

Time frame:Week 8

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

AEs, laboratory parameters, primary pharmacokinetic parameters

Time frame:Throughout study

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

Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study.
Diabetes care2009 Jul (month)PMID19366970doi:10.2337/dc08-1961via clinicaltrials gov reference derived + pubmed nct search

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.