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Type 2 DiabetesPhase 3LirabolicNCT04057261

Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease

A Phase 3 study testing Liraglutide Pen Injector [Victoza] in people with Type 2 Diabetes and Cardiovascular Diseases, run by RWTH Aachen University at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In an unbiased metabolomics approach with subsequent pathway analyses, the current study seeks to examine the effect of Liraglutide treatment on the metabolic signature in treated patients as well as the effect of Liraglutide on various echocardiographic parameters of cardiac function and rhythm profile, thus paving… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Cardiovascular Diseases
What is being tested?
Liraglutide Pen Injector [Victoza]
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteGermany
Study dates
Nov 2020to Nov 2022
Phase
Phase 3
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

  • Type 2 diabetes
  • Serum levels of HbA1c ≥ 7,0%
  • Age ≥ 18 years
  • Patients with existing cardiovascular disease: coronary heart disease, cerebrovascular disease, peripheral vascular disease, chronic kidney disease of stage III or chronic heart failure of NYHA II or III)
  • Written informed consent prior to study participation

Who cannot join

  • Type 1 diabetes
  • Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within the last 4 weeks
  • Patients with familiar or personal history of multiple endocrine neoplasia-type 2 or medullary C-cell cancer
  • Renal impairment (eGFR < 30 mL/min)
  • Occurrence of acute vascular events within 6 weeks before screening and randomization
  • Known or suspected hypersensitivity to Liraglutide
Show all 13Show fewer
  • Pregnant females as determined by positive (serum or urine) hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
  • Lactating females
  • The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
  • The subject received an investigational drug within 30 days prior to inclusion into this study.
  • The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study.
  • The subject is unwilling or unable to follow the procedures outlined in the protocol.
  • The subject is mentally or legally incapacitated.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Internal Medicine I, University Hospital

    Aachen, 52074

Other trials in Germany

About this study

In an unbiased metabolomics approach with subsequent pathway analyses, the current study seeks to examine the effect of Liraglutide treatment on the metabolic signature in treated patients as well as the effect of Liraglutide on various echocardiographic parameters of cardiac function and rhythm profile, thus paving the way for future research to explain the effects of Liraglutide on cardiovascular mortality and overall mortality in treated patients.

Being tested
Liraglutide Pen Injector [Victoza], Placebo
Keywords
Liraglutide, Type 2 Diabetes, High Cardiovascular Risk, Myocardial Infarction, Metabolic Profile
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liraglutide Pen Injector [Victoza]Drug

    Increasing dose of Liraglutide: 0.6 mg/d for the first week, 1.2 mg/d for the second week aiming for a maximum of 1.8 mg/d beginning with the third week (or highest tolerated dose).Subcutaneous injection once daily via pre-filled pen

  • PlaceboDrug

    Matching Placebo once daily, subcutaneous injection via pre-filled pen.

Study groups in NCT04057261
Study groupRoleWhat they receive
LiraglutideActive comparatorIncreasing dose of Liraglutide: 0.6 mg/d for the first week, 1.2 mg/d for the second week aiming for a maximum of 1.8 mg/d beginning with the third week (or highest tolerated dose).Subcutaneous injection once daily via pre-filled pen.
Receives: Drug: Liraglutide Pen Injector [Victoza]
PlaceboPlacebo comparatorMatching Placebo once daily, subcutaneous injection via pre-filled pen.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months

    Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months measured by a platform including 2 separate reverse phase (RP)/UPLC-MS/MS with positive ion mode electrospray ionization (ESI), (RP)/UPLC-MS/MS with negative ESI, and (HILIC)/UPLC-MS/MS with negative ESI.

    Measured: 3 month

Secondary outcomes (15)

  1. change in left ventricular diastolic function

    change in left ventricular diastolic function between baseline and after 12 weeks as determined by 2D and 3D parameter global Strain Rate E by echocardiography

    Measured: 3 month

  2. change in left ventricular diastolic function

    change in left ventricular diastolic function between baseline and after 12 weeks as determined by standardized parameter E/é and left atrial (LA) volume by echocardiography

    Measured: 3 month

  3. change in left ventricular systolic function

    change in left ventricular systolic function by ejection fraction (EF) by echocardiography

    Measured: 3 month

  4. Changes in systolic and diastolic blood pressure (mmHg)

    Changes in systolic and diastolic blood pressure (mmHg) between Liraglutide treatment group and placebo group after 1 and 3 months.

    Measured: 3 month

  5. body weight

    Measured: 3 month

  6. Changes in NT-proBNP serum levels (pg/ml)

    Changes in NT-proBNP serum levels (pg/ml) between Liraglutide treatment group versus placebo group after 1 and 3 months.

    Measured: 3 month

  7. Differences of the serum lipid profile between Liraglutide treatment group and placebo group

    Differences of the serum lipid profile including serum levels of triglycerides (mg/dl), total cholesterol (mg/dl), low-density lipoprotein cholesterol (mg/dl) and high-density lipoprotein cholesterol (mg/dl)between Liraglutide treatment group and placebo group after 1 and 3 months

    Measured: 3 month

  8. changes of serum levels of glucose, HbA1c, glucagon, insulin, C-Peptide, β-Hydroxybutyrate between Liraglutide treatment group and placebo group

    Changes in serum levels of glucose (mg/dl), HbA1c (%), glucagon (pg/ml), insulin (ng/ml), C-Peptide (ng/ml), β-Hydroxybutyrate (mmol/l) between Liraglutide treatment group and placebo group after 1 and 3 months

    Measured: 3 month

  9. Heart rate variability

    Differences in heart rate variability measured by 24 hour ECG between Liraglutide treatment group and placebo group after 3 month including the following parameters: mean heart rate (bpm), maximum/minimum heart rate (bpm) and long-term variation of RR intervals (defined as standard deviation over 24 hours of per-minute means of RR intervals).

    Measured: 3 month

  10. Resting energy expenditure

    Resting energy expenditure measured by indirect calorimetry [CardioCoach CO2]

    Measured: 3 month

  11. Respiratory Exchange Ratio

    Respiratory Exchange Ratio measured by indirect calorimetry [CardioCoach CO2]

    Measured: 3 month

  12. Differences in gut microbiome composition measured by 16S rRNA targeted gene sequencing of feces between Liraglutide treatment group and placebo group

    Differences in gut microbiome composition measured by 16S rRNA targeted gene sequencing of feces between Liraglutide treatment group and placebo group after 1 and 3 month including the following parameters: alpha diversity (reported as Shannon diversity index) and differences in bacterial composition at different taxonomic levels including genus, family and class of bacteria (reported as relative abundance).

    Measured: 3 month

  13. Albumin excretion

    Albumin excretion by 24 h urine collection

    Measured: 3 month

  14. changes in inflammasome analyses

    Differences in serum levels of inflammatory cytokines including C-reactive protein (mg/ml), Interleukin 6 (pg/ml), Interleukin 1 beta (pg/ml) and tumor necrosis factor alpha (pg/ml) between Liraglutide treatment group and placebo group after 1 and 3 month

    Measured: 3 month

  15. Differences in circulation inflammatory cell composition by flow cytometry analyses (FACS) between Liraglutide treatment group and placebo group

    Differences in circulation inflammatory cell composition by flow cytometry analyses (FACS) between Liraglutide treatment group and placebo group after 1 and 3 month including the following parameters: Numbers of T-cells including T-cell subsets and monocytes including monocyte subsets. Numbers will be reported as percentage of parent, i.e. total pool of CD45+ immune cells).

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2019
  2. Study startNov 2020 (estimated)
  3. Primary completionAug 2022 (estimated)
  4. Study completionNov 2022 (estimated)

Why it stopped: A study start is currently not foreseeable for organizational reasons. Due to the delays, research has also been focused on new compounds, which has reduced the interest in the potential results of the above-mentioned clinical trial.

Resources

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 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single center, prospective, placebo-controlled, double-blind, randomized, 2 arm parallel, interventional, exploratory pilot study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04057261
Sponsor's protocol ID
17-162
Acronym
Lirabolic
Status last verified
Mar 2021
First submitted
18 Jul 2019
Last updated
10 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Liraglutide Pen Injector [Victoza] in people with Type 2 Diabetes and Cardiovascular Diseases, run by RWTH Aachen University at 1 site in Germany.

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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 10 Mar 2021. 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 Germany. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was withdrawn before enrolling participants, so there are no results.

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?

Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months (time frame: 3 month). 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 NCT04057261.

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 10 Mar 2021.

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