← Trials/Trial dossier/NCT01499108

Liratime

CompletedPhase 4

Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes

Lead sponsor

Peter Rossing

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

32

actual

Study population

Hypertension, Type 2 diabetes

Key I/E criterion

eGFR ≥60

Primary endpoint

Ambulatory blood pressure

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 IDNCT01499108
Org study ID2011-005344-95

Timeline

Milestones

Study first posted2011-12-26estimated
Last update posted2015-02-02estimated
Study start2012-08 (month precision)
Primary completion2013-07actual (month precision)
Study completion2014-08actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

HypertensionType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee

2. Male or female patients > 18 years with type 2 diabetes (WHO criteria).

3. Patients must be on treatment with metformin. Any form of treatment with SU compounds will be discontinued and washed out for two weeks prior to the start of study drug.

4. eGFR ≥ 60 ml/min/1.73 m2 (estimated by MDRD formula)

5. Fertile female patients must use chemical, hormonal and mechanical contraceptives or be in menopause (i.e. must not have had regular menstrual bleeding for at least one year) or have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least six months prior to screening

6. Patients must be on antihypertensive treatment or having elevated blood pressure (SBP ≥130 mm Hg and DBP ≥80 mmHg), lower than 170/105 mm Hg at baseline and the patients must be stable antihypertensive medication for at least 4 weeks prior to baseline

7. Patients must be on stable hypoglycemic medication for at least two weeks before the first visit.

8. Must be able to communicate with the investigator

Exclusion criteria

1. Ongoing insulin therapy

2. BP > 170/105 mm Hg at baseline

3. Type 1 diabetes mellitus

4. Chronic pancreatitis / previous acute pancreatitis

5. Known or suspected hypersensitivity to trial product(s) or related products.

6. Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors which in the Investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening

7. Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial

8. Inflammatory bowel disease

9. Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months

10. Previous bowel resection

11. Body mass index <18.5 kg/m2

12. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods

13. Clinical signs of diabetic gastroparesis

14. Impaired liver function (transaminases > two times upper reference levels)

Endpoints (3)

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

Cardiometabolic biomarkers
2
Renal / kidney
1

Renal / kidney

1 endpoint
Secondary/protocol endpoint/low confidence

Change in ECV

Time frame:50 days

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Primary/protocol endpoint

Change in ambulatory blood pressure

Time frame:50 days

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Washout analysis

Time frame:21

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change, Body weight, absolute change (kg)

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.