Phase 4
N=23
The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02765399 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Change in Liver Fat Content — 14.8; 16.1; 10.7; 13.9 fat % — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Liraglutide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Helsinki University Central Hospital
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Liver Fat Content |
14.8; 16.1; 10.7; 13.9 | 0.001 sig |
| PRIMARY Plasma Triglyceride (TG) Area Under Curve (AUC) |
22.0; 17.5; 17.1; 19.0 | 0.011 sig |
| PRIMARY Body Weight |
98.6; 92.0; 96.1; 89.8 | 0.002 sig |
| PRIMARY Change in HbA1c Level |
7.0; 6.3; 6.4; 6.4 | 0.005 sig |
| PRIMARY Change in fP-glucose Level |
8.3; 6.5; 6.4; 6.4 | 0.001 sig |
| PRIMARY Change in Insulin Level |
13.9; 13.8; 14.5; 14.1 | 0.532 |
| PRIMARY Change in Matsuda Index |
2.5; 3.1; 3.5; 3.1 | 0.017 sig |
| PRIMARY Change in VAT Area |
3403; 2710; 3185; 2600 | 0.047 sig |
| PRIMARY Change in SAT Area |
4043; 5400; 3792; 5161 | 0.004 sig |
| PRIMARY Change in ApoCIII Level |
12.0; 9.7; 9.9; 8.6 | 0.018 sig |
| SECONDARY Change in Hepatic de Novo Lipogenesis |
15.4; 12.6; 19.1; 13.8 | 0.152 |
| SECONDARY Change in Systolic RR |
135; 145; 139; 137 | 0.173 |
| SECONDARY Mean Total Production of apoB48 |
490; 570; 329; 530 | 0.002 sig |
| SECONDARY Mean Production Rate of apoB48 in CM |
284; 190; 113; 160 | <0.001 sig |
| SECONDARY Mean apoB48 FTR to VLDL1 Particles |
12; 34; 26; 30 | <0.001 sig |
| SECONDARY Mean TG Fractional Catabolic Rates in CM |
33; 64; 46; 59 | 0.011 sig |
| SECONDARY Mean CM FDC of apoB48 |
9; 4.4; 0.8; 3.2 | <0.001 sig |
| SECONDARY Change in Direct CM-apoB48 Clearance |
106; 20; 3.8; 17 | <0.001 sig |
| SECONDARY Mean CM-apoB48 Transfer Rates to VLDL1 |
127; 170; 110; 150 | 0.017 sig |
| SECONDARY Mean VLDL1-TG Production Rates |
51; 43; 35; 35 | 0.017 sig |
| SECONDARY Mean Fractional Catabolic Rate of VLDL2-apoB100 |
6.7; 4.5; 5.6; 5.1 | 0.068 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects with type 2 diabetes treated with a lifestyle or metformin (any dose)
- waist circumference > 88 cm in women and > 92 cm in men
- BMI 27-40 kg/m2
- triglycerides between 1.0 - 4.0 mmol/L
- LDL 3x ULN
- GFR 25 mg / day)
- Blood pressure > 160 mmHg systolic and/or > 105 diastolic
- History of pancreatitis or stomach / other major bleeding, thyroid neoplasia, persistent hypothyroidism or persistent hyperthyroidism
- Any medical condition that puts the patient in the risk of dehydration
- Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
- Females of childbearing potential who are not using adequate contraceptive methods
- Subjects who have experienced side-effects previously from GLP-1 agonists
- Non-compliance or withdrawal of consent
- Any information or clinical event described in liraglutide SPC that is a contraindication for the use of liraglutide
Data sourced from ClinicalTrials.gov (NCT02765399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.