Type 2 DiabetesPhase 4LiratimeNCT01499108
Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes
A Phase 4 study testing liraglutide in people with Type 2 Diabetes, run by Peter Rossing at 1 site in Denmark.
Trial summary
Background: Preclinical blood pressure (BP) data from studies of hypoglycemic effects of liraglutide treatment (the LEAD program), revealed a significant antihypertensive potential. The time course and the mechanism behind this effect are unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Male or female patients > 18 years with type 2 diabetes (WHO criteria).
- 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.
- eGFR ≥ 60 ml/min/1.73 m2 (estimated by MDRD formula)
- 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
- 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
- Patients must be on stable hypoglycemic medication for at least two weeks before the first visit.
- Must be able to communicate with the investigator
Who cannot join
- Ongoing insulin therapy
- BP > 170/105 mm Hg at baseline
- Type 1 diabetes mellitus
- Chronic pancreatitis / previous acute pancreatitis
- Known or suspected hypersensitivity to trial product(s) or related products.
- 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
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- 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
- Inflammatory bowel disease
- 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
- Previous bowel resection
- Body mass index <18.5 kg/m2
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
- Clinical signs of diabetic gastroparesis
- Impaired liver function (transaminases > two times upper reference levels)
Trial locations and contacts
1 site in 1 country.
About this study
Background: Preclinical blood pressure (BP) data from studies of hypoglycemic effects of liraglutide treatment (the LEAD program), revealed a significant antihypertensive potential. The time course and the mechanism behind this effect are unknown.
Objectives: To evaluate the time course of the antihypertensive effect of liraglutide treatment in patients with type 2 diabetes
Read more
Design: Open-label study with intervention and subsequent washout period
Patient Population: 35 hypertensive (SBP ≥130 mm Hg and DBP ≥80 mmHg) patients with type 2 diabetes.
Intervention: All patients will be treated with liraglutide 0.6 mg once daily for 7 days and will then be titrated to 1.2 mg once daily for 14 days and then titrated to 1.8 mg once daily for 4 weeks. This is followed by a washout period of 3 weeks without liraglutide treatment.
Endpoints: 24-hour blood pressure, natriuresis, extra cellular volume (ECV
Read the detailed description
Hypotheses Primary hypothesis • Liraglutide treatment causes a reduction in 24h BP
Secondary hypothesis:
- The effect on BP may be mediated by an increase in natriuresis, thereby affecting ECV
- The effect on BP may be mediated by a decrease in arterial stiffness and central aortic pressure
Purpose Primary purpose
- To assess how quickly the antihypertensive effect of liraglutide treatment set in after initiation in patients with type 2 diabetes
Secondary objectives
- To measure the effect of liraglutide treatment on natriuresis.
- To measure the effect of liraglutide treatment on ECV
- To measure the effect of liraglutide treatment on arterial stiffness
- To measure weight change after initiation of liraglutide treatment
- Conditions
- Type 2 Diabetes
- Being tested
- liraglutide
- Keywords
- type 2 diabetes, hypertension, liraglutide, kidney function
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Also called Victoza
Subcutaneous injection of liraglutide at doses of 0.6, 1.2, and 1.8 mg once daily during the 49 days duration of the study
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | single-group study were participants recieve Liraglutide Receives: Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ambulatory blood pressure
Change in 24h BP from day 1 to day 49 (baseline to end of treatment) and time to statistically significant change in BP 24h after initiation of or increased dose of liraglutide
Measured: 50 days
Secondary outcomes (2)
Change in ECV
Changes in ECV (measured by GFR), urinary sodium, weight, arterial stiffness and daily home-BP, from day 1 to day 49 (baseline to end of treatment).
Measured: 50 days
Washout analysis
Change in 24h BP, ECV, weight, arterial stiffness from day 49 to day 70th
Measured: 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Rossing
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Peter Rossing, Steno Diabetes Center Copenhagen
- Investigators
- Peter Rossing, MD, Principal investigator, Steno Diabetes Centes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499108
- Sponsor's protocol ID
- 2011-005344-95
- Acronym
- Liratime
- Status last verified
- Jul 2013
- First submitted
- 12 Dec 2011
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
von Scholten BJ, Hansen TW, Goetze JP, Persson F, Rossing P. Glucagon-like peptide 1 receptor agonist (GLP-1 RA): long-term effect on kidney function in patients with type 2 diabetes. J Diabetes Complications. 2015 Jul;29(5):670-4. doi: 10.1016/j.jdiacomp.2015.04.004. Epub 2015 Apr 11.
PubMed 25935863
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course of the Blood Pressure Lowering Effect of Liraglutide Therapy in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01499108
- Acronym / sponsor ID
- Liratime / 2011-005344-95
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, hypertension, liraglutide, kidney function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Peter RossingUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Preclinical blood pressure (BP) data from studies of hypoglycemic effects of liraglutide treatment (the LEAD program), revealed a significant antihypertensive potential. The time course and the mechanism behind this effect are unknown.
Objectives: To evaluate the time course of the antihypertensive effect of liraglutide treatment in patients with type 2 diabetes
Design: Open-label study with intervention and subsequent washout period
Patient Population: 35 hypertensive (SBP ≥130 mm Hg and DBP ≥80 mmHg) patients with type 2 diabetes.
Intervention: All patients will be treated with liraglutide 0.6 mg once daily for 7 days and will then be titrated to 1.2 mg once daily for 14 days and then titrated to 1.8 mg once daily for 4 weeks. This is followed by a washout period of 3 weeks without liraglutide treatment.
Endpoints: 24-hour blood pressure, natriuresis, extra cellular volume (ECV
Detailed description
Hypotheses Primary hypothesis • Liraglutide treatment causes a reduction in 24h BP
Secondary hypothesis:
- The effect on BP may be mediated by an increase in natriuresis, thereby affecting ECV
- The effect on BP may be mediated by a decrease in arterial stiffness and central aortic pressure
Purpose Primary purpose
- To assess how quickly the antihypertensive effect of liraglutide treatment set in after initiation in patients with type 2 diabetes
Secondary objectives
- To measure the effect of liraglutide treatment on natriuresis.
- To measure the effect of liraglutide treatment on ECV
- To measure the effect of liraglutide treatment on arterial stiffness
- To measure weight change after initiation of liraglutide treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: liraglutidesingle-group study were participants recieve Liraglutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Male or female patients > 18 years with type 2 diabetes (WHO criteria).
- 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.
- eGFR ≥ 60 ml/min/1.73 m2 (estimated by MDRD formula)
- 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
Key exclusion criteria (14 listed)
- Ongoing insulin therapy
- BP > 170/105 mm Hg at baseline
- Type 1 diabetes mellitus
- Chronic pancreatitis / previous acute pancreatitis
- Known or suspected hypersensitivity to trial product(s) or related products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideAlso: VictozaSubcutaneous injection of liraglutide at doses of 0.6, 1.2, and 1.8 mg once daily during the 49 days duration of the study | Drug | Liraglutide |
Primary outcome
Change in ambulatory blood pressure
Time frame: 50 days
Change in 24h BP from day 1 to day 49 (baseline to end of treatment) and time to statistically significant change in BP 24h after initiation of or increased dose of liraglutide
2 secondary outcomes
Change in ECV
Time frame: 50 days
Washout analysis
Time frame: 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
- Derived from this study: PubMed 25935863von Scholten BJ, Hansen TW, Goetze JP, Persson F, Rossing P. Glucagon-like peptide 1 receptor agonist (GLP-1 RA): long-term effect on kidney function in patients with type 2 diabetes. J Diabetes Complications. 2015 Jul;29(5):670-4. doi: 10.1016/j.jdiacomp.2015.04.004. Epub 2015 Apr 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rossing, MD principal investigator
Steno Diabetes Centes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing liraglutide in people with Type 2 Diabetes, run by Peter Rossing at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ambulatory blood pressure (time frame: 50 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01499108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2015.