Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003229-18 | EudraCT Number | ||
| U1111-1111-9161 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Europe. The aim of this trial is to investigate whether a new compound, liraglutide, reduces the level of lipids (fat), including cholesterol, in the blood of type 2 diabetics, following a meal with high fat content.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | In the first 3-week period, the treatment will be one week with 0.6 mg, one week with 1.2 mg and one week with 1.8 mg liraglutide. Subsequently, a wash-out period of 3 to 9 weeks occurs and then a second period of 3 weeks' treatment with placebo. At the end of each of the 2 treatment periods, a high fat meal test will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-8h (triglyceride), the area under the triglyceride-concentration-time curve in the interval 0-8 hours following a meal with a high fat content | after 3 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| FFA (Free Fatty Acid), VLDL (Very Low Density), and apoB48: AUC0-8 hours after meal with a high fat content | after 3 weeks of treatment | |
| Glucose, insulin, C-peptide and glucagon: AUC0-8 hours after meal with a high fat content | after 3 weeks of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23683069 | Result | Hermansen K, Baekdal TA, During M, Pietraszek A, Mortensen LS, Jorgensen H, Flint A. Liraglutide suppresses postprandial triglyceride and apolipoprotein B48 elevations after a fat-rich meal in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, cross-over trial. Diabetes Obes Metab. 2013 Nov;15(11):1040-8. doi: 10.1111/dom.12133. Epub 2013 Jun 11. | |
| 26225223 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo | Drug | In the first 3-week period, the treatment will be with placebo. Subsequently, a wash-out period of 3 to 9 weeks occurs and then a second period of one week with 0.6 mg, one week with 1.2 mg and one week with 1.8 mg of liraglutide. At the end of each of the 2 treatment periods, a high fat meal test will be performed. |
|
| Result |
| Roge RM, Klim S, Ingwersen SH, Kjellsson MC, Kristensen NR. The Effects of a GLP-1 Analog on Glucose Homeostasis in Type 2 Diabetes Mellitus Quantified by an Integrated Glucose Insulin Model. CPT Pharmacometrics Syst Pharmacol. 2015 Jan;4(1):e00011. doi: 10.1002/psp4.11. Epub 2014 Dec 30. |
| 25603819 | Derived | Petri KC, Jacobsen LV, Klein DJ. Comparable liraglutide pharmacokinetics in pediatric and adult populations with type 2 diabetes: a population pharmacokinetic analysis. Clin Pharmacokinet. 2015 Jun;54(6):663-70. doi: 10.1007/s40262-014-0229-z. |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |