Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1127-4819 | 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 the impact of low blood sugar during the night on sleep in subjects with type 2 diabetes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normoglycaemia followed by hypoglycaemia | Other |
| |
| Hypoglycaemia followed by normoglycaemia | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucose clamp | Other | Each subject will complete one adaptation night visit followed by two experimental night visits, one normoglycaemic and one hypoglycaemic, in randomised order. While subjects are asleep, sleep patterns will be monitored online using polysomnographic recordings during a hypoglycaemic and a normoglycaemic clamp (using constant intravenous (i.v.) infusion of human soluble insulin (Actrapid®)). Plasma glucose will be monitored. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of electroencephalogram (EEG) identified arousals | During the first four hours (0-4 hours) after reaching sleep stage N2 |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in the different sleep stages (% of total sleep time): Sleep stage N1, Sleep stage N2, Sleep stage N3 and Rapid Eye Movement (REM) sleep | During the first four hours (0-4 hours) after reaching sleep stage N2 | |
| Total sleep time | 0-8 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26407587 | Result | Jennum P, Stender-Petersen K, Rabol R, Jorgensen NR, Chu PL, Madsbad S. The Impact of Nocturnal Hypoglycemia on Sleep in Subjects With Type 2 Diabetes. Diabetes Care. 2015 Nov;38(11):2151-7. doi: 10.2337/dc15-0907. Epub 2015 Sep 25. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
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 |
|---|---|
| D015309 | Glucose Clamp Technique |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D003933 | Diagnosis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |