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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003228-44 | EudraCT Number | ||
| U1111-1111-9119 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this clinical trial is to investigate the effect of liraglutide on gastric emptying, energy expenditure and appetite, and to evaluate liraglutide pharmacokinetics in non-diabetic obese volunteers. The trial is designed as a two-period, six-sequenced, crossover trial where the trial participant will enter two treatment periods with a wash-out period of 6-8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Experimental |
| |
| E | Experimental |
| |
| F | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | High dose liraglutide treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol | after 35 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles | after 35 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Maastricht | 6229 ER | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23999198 | Result | van Can J, Sloth B, Jensen CB, Flint A, Blaak EE, Saris WH. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults. Int J Obes (Lond). 2014 Jun;38(6):784-93. doi: 10.1038/ijo.2013.162. Epub 2013 Sep 3. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| liraglutide | Drug | Low dose liraglutide treatment (1.8 mg) followed by high dose liraglutide treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening. |
|
| liraglutide | Drug | Low dose liraglutide treatment (1.8 mg) followed by high placebo treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening. |
|
| liraglutide | Drug | High placebo treatment (3.0 mg) followed by low dose liraglutide treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening. |
|
| liraglutide | Drug | High dose liraglutide treatment (3.0) followed by low placebo treatment (1.8 mg). Injected s.c. (under the skin) once daily in the evening. |
|
| liraglutide | Drug | Low placebo treatment (1.8 mg) followed by high dose liraglutide treatment (3.0 mg). Injected s.c. (under the skin) once daily in the evening. |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |