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This trial is conducted in Europe. The aim of this trial is to establish the dose response relationship on glycaemic control of five dose levels of NNC90-1170.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 0.045 mg | Experimental |
| |
| 0.225 mg | Experimental |
| |
| 0.45 mg | Experimental |
| |
| 0.60 mg | Experimental |
| |
| 0.75 mg | Experimental |
| |
| Glim | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Once daily injection, under the skin (s.c.) for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycosylated haemoglobin) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | ||
| Fructosamine | ||
| 7-point blood glucose profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452), MD | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Århus C | 8000 | Denmark | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15161785 | Result | Madsbad S, Schmitz O, Ranstam J, Jakobsen G, Matthews DR; NN2211-1310 International Study Group. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Diabetes Care. 2004 Jun;27(6):1335-42. doi: 10.2337/diacare.27.6.1335. | |
| 25504028 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| liraglutide |
| Drug |
Once daily injection, under the skin (s.c.) for 12 weeks |
|
|
| glimepiride | Drug | Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response |
|
| Adverse events |
| Copenhagen |
| 2400 |
| Denmark |
| Novo Nordisk Investigational Site | Hvidovre | 2650 | Denmark |
| Novo Nordisk Investigational Site | Kolding | 6000 | Denmark |
| Novo Nordisk Investigational Site | Køge | 4600 | Denmark |
| Novo Nordisk Investigational Site | Thisted | 7700 | Denmark |
| Novo Nordisk Investigational Site | Bekkestua | 1357 | Norway |
| Novo Nordisk Investigational Site | Elverum | 2408 | Norway |
| Novo Nordisk Investigational Site | Harstad | 9480 | Norway |
| Novo Nordisk Investigational Site | Oslo | 0370 | Norway |
| Novo Nordisk Investigational Site | Gothenburg | 413 45 | Sweden |
| Novo Nordisk Investigational Site | Grästorp | 467 22 | Sweden |
| Novo Nordisk Investigational Site | Lund | 221 85 | Sweden |
| Novo Nordisk Investigational Site | Örebro | 701 85 | Sweden |
| Novo Nordisk Investigational Site | Uppsala | 751 85 | Sweden |
| Novo Nordisk Investigational Site | Ayrsh | KA2 0BE | United Kingdom |
| Novo Nordisk Investigational Site | Church Village | CF38 1AB | United Kingdom |
| Novo Nordisk Investigational Site | Edinburgh | EH16 4SA | United Kingdom |
| Novo Nordisk Investigational Site | Enfield | EN2 8JL | United Kingdom |
| Novo Nordisk Investigational Site | Hull | HU3 2JZ | United Kingdom |
| Novo Nordisk Investigational Site | Leicester | LE5 4PW | United Kingdom |
| Novo Nordisk Investigational Site | Liverpool | L7 8XP | United Kingdom |
| Novo Nordisk Investigational Site | Northampton | NN1 5BD | United Kingdom |
| Novo Nordisk Investigational Site | Nottingham | NG7 2UH | United Kingdom |
| Novo Nordisk Investigational Site | Oxford | OX2 6HE | United Kingdom |
| Novo Nordisk Investigational Site | Plymouth | PL8 8DQ | United Kingdom |
| Novo Nordisk Investigational Site | Rugby | CV22 5PX | United Kingdom |
| Novo Nordisk Investigational Site | Sheffield | S5 7AU | United Kingdom |
| Novo Nordisk Investigational Site | Worksop | S81 OBD | United Kingdom |
| Result |
| Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. |
| 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 |
| C057619 | glimepiride |
| 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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