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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011269-95 | EudraCT Number | ||
| U1111-1111-8859 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068.
The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Active Comparator |
| |
| D | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/liraglutide | Drug | Single, simultaneous dose of NN9068, injected s.c. (under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes | assessed 0-96 hours after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the NN2211 concentration-time curve after single-dose | assessed 0-72 hours after trial product administration | |
| The area under the NN1250 concentration-time curve after single-dose | assessed 0-96 hours after trial product administration |
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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 | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25998481 | Result | Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 10.1002/jcph.549. Epub 2015 Jul 14. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000613158 | IDegLira |
| C571886 | insulin degludec |
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| insulin degludec | Drug | Single, simultaneous dose of NN1250, injected s.c. (under the skin) |
|
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| liraglutide | Drug | Single, simultaneous dose of NN2211, injected s.c. (under the skin) |
|
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| placebo | Drug | Single, simultaneous dose of placebo, injected s.c. (under the skin) |
|
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |