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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1111-9256 | Other Identifier | WHO | |
| 2010-021057-39 | EudraCT Number |
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This trial is conducted in Europe and the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of multiple doses of liraglutide in the pediatric population (children).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I.a | Experimental |
| |
| I.b | Placebo Comparator |
| |
| II.a | Experimental |
| |
| II.b | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and type of adverse events | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the plasma concentration vs. time curve | within dosing interval | |
| Pharmacodynamics: Fasting Plasma Glucose (FPG) and insulin | throughout study duration (pre-, during and post-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 | Cypress | California | 90630 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25036533 | Result | Klein DJ, Battelino T, Chatterjee DJ, Jacobsen LV, Hale PM, Arslanian S; NN2211-1800 Study Group. Liraglutide's safety, tolerability, pharmacokinetics, and pharmacodynamics in pediatric type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Diabetes Technol Ther. 2014 Oct;16(10):679-87. doi: 10.1089/dia.2013.0366. Epub 2014 Jul 18. | |
| 25603819 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Increasing dose for self-injection subcutaneously (under the skin) daily over 5 weeks (0.3 - 1.8 mg) |
|
| liraglutide | Drug | Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg). |
|
| placebo | Drug | Increasing dose for self-injection subcutaneously (under the skin) daily over 3 to 4 weeks (0.6 - 1.8 mg). |
|
| Los Angeles |
| California |
| 90036 |
| United States |
| Novo Nordisk Investigational Site | Los Angeles | California | 90048-1869 | United States |
| Novo Nordisk Investigational Site | Aurora | Colorado | 80045 | United States |
| Novo Nordisk Investigational Site | Iowa City | Iowa | 52242 | United States |
| Novo Nordisk Investigational Site | Louisville | Kentucky | 40202 | United States |
| Novo Nordisk Investigational Site | Kansas City | Missouri | 64108-4619 | United States |
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45229 | United States |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44106 | United States |
| Novo Nordisk Investigational Site | Toledo | Ohio | 43606 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15224 | United States |
| Novo Nordisk Investigational Site | Memphis | Tennessee | 38103-2800 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75235 | United States |
| Novo Nordisk Investigational Site | Brussels | 1090 | Belgium |
| Novo Nordisk Investigational Site | Ljubljana | 1525 | Slovenia |
| Novo Nordisk Investigational Site | Birmingham | B4 6NH | United Kingdom |
| Novo Nordisk Investigational Site | Manchester | M13 9WL | United Kingdom |
| Novo Nordisk Investigational Site | Nottingham | NG7 2UH | United Kingdom |
| Novo Nordisk Investigational Site | Sheffield | S102TH | United Kingdom |
| 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. |
| 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 |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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