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NCT02765399

The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis

Completed Phase 4 Results posted Last updated 12 April 2022
What this trial tests

Phase 4 trial testing Liraglutide in Type 2 Diabetes in 23 participants. Completed in 28 February 2019.

Timeline
1 February 2015
Primary endpoint
28 February 2019
28 February 2019

Quick facts

Lead sponsorHelsinki University Central Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment23
Start date1 February 2015
Primary completion28 February 2019
Estimated completion28 February 2019
Sites1 location across Finland

Drugs / interventions tested

Conditions studied

Sponsor

Helsinki University Central Hospital

Who can join

Adults 30 to 75, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Liver Fat Content Primary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): mean liver fat content was measured by magnetic resonance imaging. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide14.8± 7.4
Placebo16.1± 9.3
16 weeks
GroupValue95% CI
Liraglutide10.7± 6.3
Placebo13.9± 9.7
Plasma Triglyceride (TG) Area Under Curve (AUC) Primary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): postprandial plasma TG summary measured using the trapezoidal rule and expressed as AUC (at fasting and at 0.5, 1, 2, 3, 4, 6 and 8 hours) after oral fat tolerance test. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide22.0± 7.4
Placebo17.5± 4.8
16 weeks
GroupValue95% CI
Liraglutide17.1± 5.0
Placebo19.0± 6.2
Body Weight Primary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): Change in body weight. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide98.6± 11.0
Placebo92.0± 7.4
16 weeks
GroupValue95% CI
Liraglutide96.1± 11.2
Placebo89.8± 6.3
Change in HbA1c Level Primary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): Change in B -Hemoglobiini-A1c level in plasma. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide7.0± 1.0
Placebo6.3± 0.3
16 weeks
GroupValue95% CI
Liraglutide6.4± 0.7
Placebo6.4± 0.5
Change in fP-glucose Level Primary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): concentration of fasting plasma glucose measured using the hexokinase method. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide8.3± 2.4
Placebo6.5± 0.8
16 weeks
GroupValue95% CI
Liraglutide6.4± 1.2
Placebo6.4± 0.9
Change in Insulin Level Primary · Baseline and after16 weeks

Before vs after intervention (Liraglutide or placebo): Concentration of insulin level in plasma measured using electrochemiluminescence. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide13.9± 4.8
Placebo13.8± 6.9
16 weeks
GroupValue95% CI
Liraglutide14.5± 4.9
Placebo14.1± 5.5
Change in Matsuda Index Primary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): Matsuda index was calculated for assessment of insulin sensitivity in plasma at time points 0, 30, 60 and 120 minutes using formula 10,000/square root of \[fasting glucose x fasting insulin\] x \[mean glucose x mean insulin during oral glucose tolerance test\]. The Matsuda index is considered to be the gold standard to determine insulin sensitivity without glucose clamp studies (Matsuda M, DeFronzo RA. Diabetes Care. 22:1462-70). Subjects who don't have insulin resistance have values of Matsuda Index of 2.5 or higher (Kerman WN et al. Stro

Baseline
GroupValue95% CI
Liraglutide2.5± 1.0
Placebo3.1± 1.7
16 weeks
GroupValue95% CI
Liraglutide3.5± 1.8
Placebo3.1± 1.3
Change in VAT Area Primary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): visceral adipose tissue area measured by magnetic resonance imaging (MRI). Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide3403± 941
Placebo2710± 836
16 weeks
GroupValue95% CI
Liraglutide3185± 1014
Placebo2600± 825
Change in SAT Area Primary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): subcutaneous adipose tissue area measured by magnetic resonance imaging (MRI). Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide4043± 1129
Placebo5400± 1598
16 weeks
GroupValue95% CI
Liraglutide3792± 1185
Placebo5161± 1653
Change in ApoCIII Level Primary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): apolipoprotein CIII concentration in plasma measured by using turbidimetric immunoassay. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide12.0± 4.4
Placebo9.7± 2.8
16 weeks
GroupValue95% CI
Liraglutide9.9± 3.7
Placebo8.6± 1.8
Change in Hepatic de Novo Lipogenesis Secondary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): Hepatic DNL is calculated from enrichment of deuterated water ingested during the kinetic study at specified time points (0, 4 and 8 hrs.). Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide15.4± 7.4
Placebo12.6± 7.5
16 weeks
GroupValue95% CI
Liraglutide19.1± 13.1
Placebo13.8± 11.2
Change in Systolic RR Secondary · Baseline and after 16 weeks

Before vs after intervention (Liraglutide or placebo): systolic blood pressure measurements. Results from Matikainen et al. Diabetes Obes Metab 21:84-94; 2019.

Baseline
GroupValue95% CI
Liraglutide135± 14
Placebo145± 10
16 weeks
GroupValue95% CI
Liraglutide139± 11
Placebo137± 11

Adverse events — posted to ClinicalTrials.gov

Time frame: During 16 weeks of Liraglutide therapy. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Liraglutide
Serious: 0/16 (0%)
Deaths: 0/16
Placebo
Serious: 0/7 (0%)
Deaths: 0/7
Other adverse events (1 terms — click to expand)

ReactionSystemLiraglutidePlacebo
NauseaGeneral disorders

Data from ClinicalTrials.gov NCT02765399 adverse events section.

Sponsor's own description

This study aims to evaluate the mechanisms underlying the effect of incretin therapy on lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of liraglutide on hepatic de novo lipogenesis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Liraglutide treatment improves postprandial lipid metabolism and cardiometabolic risk factors in humans with adequately controlled type 2 diabetes: A single-centre randomized controlled study.
    Matikainen N, Söderlund S, Björnson E, Pietiläinen K, et al · · 2019 · cited 91× · PMID 30073766 · DOI 10.1111/dom.13487

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