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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002173-22 | EudraCT Number | ||
| U1111-1143-1206 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the effects of semaglutide on ß-cell function in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | Total of 12 visits |
|
| Placebo | Placebo Comparator | Total of 12 visits |
|
| Healthy subjects | No Intervention | Total of 2 visits |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin concentration time curve from 0 to 10 minutes after a 25 g glucose bolus i.v. infusion (IVGTT,intravenous glucose tolerance test) over 2 minutes | Day -1, day 86 | |
| Area under the serum insulin concentration time curve from 10-120 minutes after a 25 g glucose bolus i.v. infusion (IVGTT). | Day -1, day 86 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. glucose challenge | Day -1, day 86 | |
| Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge | Day -1, day 86 |
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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 |
|---|---|---|---|
| 28526920 | Result | Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
|---|---|
| C000591245 | semaglutide |
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| placebo | Drug | Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks. |
|
| 24-hour plasma glucose, glucagon, serum insulin, and C-peptide measured as total AUC0-24h during a test day with 3 standardised meals | Day -1, day 85 |
| Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. arginine application; ISR will be derived from the C-peptide concentration profile | Day -1, day 86 |
| Area under the ISR curve over the 5-12 mmol/L (90-216 mg/dL) glucose interval; ISR will be derived from the C-peptide concentration profile | Day -1, day 87 |
| Slope of the ISR vs. glucose curve (dose-response relationship) | Day -1, day 87 |