ADELANTE

WithdrawnPhase 4

A Long-term Trial to Compare the Effects of Liraglutide and Sulphonylurea (Glimepiride) Both in Combination With Metformin on Clinical, Endothelial and Image Markers of Cardiovascular Risk in Patients With Type 2 Diabetes

A Long-term, Randomized, Open-labeled, Parallel-group Trial to Compare the Effects of Liraglutide and Sulphonylurea (Glimepiride) Both in Combination With Metformin on Clinical, Endothelial and Image Markers of Cardiovascular Risk in Patients With Type 2 Diabetes

Lead sponsor

Fundación Fernández-Cruz

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-9%

Primary endpoint

•Assess the effect of treatment with liraglutide

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 IDNCT01593137

Org study IDFFC-0001

Secondary ID2012-000311-87

Timeline

Milestones

Study first posted2012-05-07estimated

Last update posted2013-07-02estimated

Study start2012-05 (month precision)

Primary completion2013-12estimated (month precision)

Study completion2014-12estimated (month precision)

Assets

Investigational agents

Liraglutide

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

•Informed written consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject).

•Male or female patients between 18 and 75 years old;

•Subjects diagnosed with type 2 diabetes for more than 1 year

•Insulin naïve subjects (Allowed are: Previous short term insulin treatment < 28 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods < 14 days in total)

•Subjects previously treated with metformin at a minimum dose of 1500 mg/day

•HbA1c from 7% to 9%

•Adherence to injection therapy

Exclusion criteria

•Type 1 diabetic patients;

•Use of a GLP-1 receptor agonist (exenatide, liraglutide or other), pramlintide, thiazolidinediones or any DPP-4 inhibitor within the 3 months prior to screening;

•Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (or their partners). Adequate contraceptive measures are considered the use of hormonal based contraceptives in combination with a barrier contraception,

•Patients with a clinical history of serious cardiovascular events in the last 3 months (myocardial infarction, unstable angina, cerebral infarction, TIA, peripheral arteriopathic event);

•Suspected or confirmed acute pancreatitis;

•Personal history of medullary thyroid carcinoma;

•Patients with congestive heart failure (NYHA I-IV);

•Moderate or severe renal failure (creatinine clearance < 60 ml/min);

•Patients with hepatic failure. This is AST or ALT > 3 times the upper limit of normal, history of cirrhosis or hepatitis;

•Patients with cancer in the last 10 years;

•Patients with terminal diseases;

•Patients unlikely to comply with trial procedures;

•Known psychiatric disease which may interfere with study procedure;

•Any other pathology which may interfere with the study results at the investigator's discretion;

•Known or suspected contraindications to or history of hypersensitivity to the trial product or related products;

•Previous participation in this trial i.e. randomised;

•The receipt of any investigational product within 30 days.

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

Other (unclassified)

Cardiometabolic biomarkers

Safety / tolerability / PK

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint/low confidence

assess the efficacy of liraglutide compared to glimepiride, as add-on to metformin, with regards to other surrogate biomarkers of cardiovascular risk: IMT, Central BP, CD40L, hsCRP, Lp-PLA2, BNP.

Time frame:1 year

change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety parameters of glycaemic control: HbA1c, FPG

Time frame:1 year

descriptive

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

assess the effect of treatment with liraglutide compared to glimepiride, as add-on to metformin, for one year on circulating levels of EPCs in patients with type 2 diabetes poorly controlled.

Time frame:1 year

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Relationship between EPC levels and all these biomarkers in patients treated with liraglutide compared to those treated with glimepiride.

Time frame:1 year

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.