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The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes This trial is conducted in Europe and North America.
The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.
The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes. A 26 week, randomised, open-label, parallel-group, multicentre, multinational Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.
• Insulin detemir + Lira 1.8 (Experimental): Disclaimer:This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice ofa healthcare professional and should not be construed as providing advice or making a recommendation. The information onthis site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specificproduct is correct for a particular patient. If you have questions regarding any information contained on this site you shouldconsult a physician.
Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.
Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a • Non-Randomised Lira 1.8 (Experimental): Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.
Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.
Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.
Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a • Subjects diagnosed with type 2 diabetes, • Previous treatment with insulin (except for insulin naïve and treated with metformin as monotherapy for at least 3 months prior to intercurrent illness at the discretion of the screening, at a stable dose of at least 1500 • Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in Disclaimer:This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice ofa healthcare professional and should not be construed as providing advice or making a recommendation. The information onthis site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specificproduct is correct for a particular patient. If you have questions regarding any information contained on this site you shouldconsult a physician.
dose), both at a stable dose for at least 3 months prior to screening. Previous short- term insulin treatment in connection with • Uncontrolled treated/untreated hypertension • Cancer or any clinically significant disease or subjects on metformin in combination with a • Previous participation in the run-in phase of • History of chronic pancreatitis or idiopathic Week 52 (for intensified subjects in original Week 52 (Values before Intensification as • Mean change from Randomisation in Fasting • Mean change from Randomisation in Fasting • Mean Change from Randomisation in 7-point Plasma Glucose Profile (self-measured) at • Mean Change from Randomisation in 7-point Plasma Glucose Profile (self-measured) at Disclaimer:This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice ofa healthcare professional and should not be construed as providing advice or making a recommendation. The information onthis site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specificproduct is correct for a particular patient. If you have questions regarding any information contained on this site you shouldconsult a physician.
• Mean Change from Randomisation in Fasting • Mean Change from Randomisation in Fasting • Mean Change from Randomisation in Fasting • Mean Change from Randomisation in Fasting • Mean Change from Randomisation in Fasting • Mean Change from Randomisation in Fasting • Mean Change from Randomisation in Lipids: • Mean Change from Randomisation in Lipids: • Mean Change from Randomisation in Lipids: • Mean Change from Randomisation in Lipids: • Mean Change from Randomisation in Body Disclaimer:This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice ofa healthcare professional and should not be construed as providing advice or making a recommendation. The information onthis site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specificproduct is correct for a particular patient. If you have questions regarding any information contained on this site you shouldconsult a physician.
• Mean Change from Randomisation in Body • Mean Change from Randomisation in Waist • Mean Change from Randomisation in Waist • Mean Change from Randomisation in Hip • Mean Change from Randomisation in Hip • Mean Change from Randomisation in Waist • Mean Change from Randomisation in Waist • Mean Change from Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.
• Mean Change from Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.
• Adverse Events from Run-in (week -12) to • Hypoglycaemic Episodes (Excluding Outlier Disclaimer:This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice ofa healthcare professional and should not be construed as providing advice or making a recommendation. The information onthis site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specificproduct is correct for a particular patient. If you have questions regarding any information contained on this site you shouldconsult a physician.
Belgium: Federal Agency for Medicines and Health Products France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medicinal Devices Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration For trials conducted in the US: (+1) 866-867-7178 Novo Nordisk affiliation: Novo Nordisk A/S • Sustained glycemic control and weight reduction in type 2 diabetes after sequential addition of liraglutide and then insulin detemir to metformin. Diabetes Complications 2013; • Devries J Hans, Bain Stephen C, Rodbard Helena W, Seufert Jochen, D'Alessio David, Thomsen Anne B, Zychma Marcin, Rosenstock Julio. Sequential Intensification of Metformin Treatment in Type 2 Diabetes With Liraglutide Followed by Randomized Addition of Basal Insulin Prompted by A1C Targets. Diabetes care 2012; http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&m url=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125 • US: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ Protocol Information Published: 05.Mar.2009 Protocol Information Last Updated: 04.Jul.2013 Disclaimer:This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice ofa healthcare professional and should not be construed as providing advice or making a recommendation. The information onthis site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specificproduct is correct for a particular patient. If you have questions regarding any information contained on this site you shouldconsult a physician.
Disclaimer:This document contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice ofa healthcare professional and should not be construed as providing advice or making a recommendation. The information onthis site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specificproduct is correct for a particular patient. If you have questions regarding any information contained on this site you shouldconsult a physician.

Source: http://srv131.novo.dk/Website/pdf/registry/nn22111842.pdf