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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1242-5426 | Other Identifier | World Health Organization (WHO) | |
| 2019-004234-42 | Registry Identifier | European Medicines Agency (EudraCT) |
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COVID19 impact on this trial was evaluated and a delay of at least 6-9 months was expected. In parallel, the development of a new type of pen injector, which was an important part of the trial, was ceased and thus this trial was cancelled.
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This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide 0.50 mg | Experimental | Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.50 mg. |
|
| Semaglutide 0.25 mg | Active Comparator | Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.25 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycosylated haemoglobin (HbA1c) | Percent-point | From baseline (week 0) to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting plasma glucose | mmol/L | From baseline (week 0) to week 12 |
| Change in body weight | Kg | From baseline (week 0) to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor & Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Buena Park | California | 90620 | United States | ||
| Novo Nordisk Investigational Site |
According to the Novo Nordisk disclosure commitment on novonordisk-trials. com
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| Number of treatment emergent adverse events (TEAEs) | Count | From baseline (week 0) to week 12 |
| Number of treatment emergent gastrointestinal adverse events | Count | From baseline (week 0) to week 12 |
| Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes | Count | From baseline (week 0) to week 12 |
| Change in pulse rate | Beats per minute (bpm) | From baseline (week 0) to week 12 |
| Number of treatment emergent adverse events (TEAEs) | Count | From week 12 to week 17 |
| Fresno |
| California |
| 93720 |
| United States |
| Novo Nordisk Investigational Site | San Jose | California | 95148 | United States |
| Novo Nordisk Investigational Site | Walnut Creek | California | 94598 | United States |
| Novo Nordisk Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Novo Nordisk Investigational Site | Honolulu | Hawaii | 96814 | United States |
| Novo Nordisk Investigational Site | Idaho Falls | Idaho | 83404-7596 | United States |
| Novo Nordisk Investigational Site | Indianapolis | Indiana | 46260 | United States |
| Novo Nordisk Investigational Site | Troy | Michigan | 48098 | United States |
| Novo Nordisk Investigational Site | Albany | New York | 12206 | United States |
| Novo Nordisk Investigational Site | West Seneca | New York | 14224 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75390-9302 | United States |
| Novo Nordisk Investigational Site | Round Rock | Texas | 78681 | United States |
| Novo Nordisk Investigational Site | Sugar Land | Texas | 77478 | United States |
| Novo Nordisk Investigational Site | Graz | 8036 | Austria |
| Novo Nordisk Investigational Site | Stockerau | 2000 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1090 | Austria |
| Novo Nordisk Investigational Site | Vienna | 1130 | Austria |
| Novo Nordisk Investigational Site | Jyväskylä | 40100 | Finland |
| Novo Nordisk Investigational Site | Kuopio | 70100 | Finland |
| Novo Nordisk Investigational Site | Lahti | 15100 | Finland |
| Novo Nordisk Investigational Site | Raisio | 21200 | Finland |
| Novo Nordisk Investigational Site | Seinäjoki | 60220 | Finland |
| Novo Nordisk Investigational Site | Gothenburg | 413 45 | Sweden |
| Novo Nordisk Investigational Site | Malmö | 205 02 | Sweden |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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