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Clinical Trial Details

Trial ID: L3204
Source ID: NCT00856986
Associated Drug: Liraglutide
Title: The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00856986/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: liraglutide|DRUG: insulin detemir|DRUG: metformin
Outcome Measures: Primary: Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26., Week 0 (Randomisation), week 26 | Secondary: Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group), Week 0, Week 52|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF), Week 0, Week 52|Mean Change From Randomisation in Fasting Plasma Glucose at Week 26, Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Fasting Plasma Glucose at Week 52, Week 0, Week 52|Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26, Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively., Week 0 (Randomisation), Week 26|Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52, Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively., Week 0, Week 52|Mean Change From Randomisation in Fasting Insulin at Week 26, Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Fasting Insulin at Week 52, Week 0 (Randomisation), Week 52|Mean Change From Randomisation in Fasting Pro-insulin at Week 26., Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Fasting Pro-insulin at Week 52, Week 0, Week 52|Mean Change From Randomisation in Fasting C-peptide at Week 26., Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Fasting C-peptide at Week 52., Week 0, Week 52|Mean Changes From Randomisation in Cholesterol Lipids at Week 26., Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C), Week 0 (Randomisation), Week 26|Mean Changes From Randomisation in Cholesterol Lipids at Week 52., Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C), Week 0, Week 52|Mean Change From Randomisation in Lipids: Triglycerides at Week 26, Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Lipids: Triglycerides at Week 52, Week 0, Week 52|Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26, Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52, Week 0, Week 52|Mean Change From Randomisation in Body Weight at Week 26, Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Body Weight at Week 52, Week 0, Week 52|Mean Change From Randomisation in Waist Circumference at Week 26., Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Waist Circumference at Week 52., Week 0, Week 52|Mean Change From Randomisation in Hip Circumference at Week 26, Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Hip Circumference at Week 52, Week 0, week 52|Mean Change From Randomisation in Waist to Hip Ratio at Week 26, Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference, Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Waist to Hip Ratio at Week 52, Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference, Week 0, Week 52|Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26., Week 0 (Randomisation), Week 26|Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52., Week 0, Week 52|Adverse Events From Run-in (Week -12) to Week 52, Run-in (week -12) to Week 52|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26, Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., weeks 0-26|Hypoglycaemic Episodes Weeks 0-52, Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., Week 0-52
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 987
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-03
Completion Date: 2010-11
Results First Posted: 2011-05-13
Last Update Posted: 2017-03-08
Locations: Novo Nordisk Investigational Site, Alexander City, Alabama, 35010, United States|Novo Nordisk Investigational Site, Birmingham, Alabama, 35294, United States|Novo Nordisk Investigational Site, Encino, California, 91436, United States|Novo Nordisk Investigational Site, Fullerton, California, 92835, United States|Novo Nordisk Investigational Site, Inglewood, California, 90301, United States|Novo Nordisk Investigational Site, La Jolla, California, 92037, United States|Novo Nordisk Investigational Site, Los Gatos, California, 95032, United States|Novo Nordisk Investigational Site, Montclair, California, 91763, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Tustin, California, 92780, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Waterbury, Connecticut, 06712, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Clearwater, Florida, 33765, United States|Novo Nordisk Investigational Site, Jupiter, Florida, 33458-7200, United States|Novo Nordisk Investigational Site, Miami, Florida, 33136, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, Miami, Florida, 33169, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30308-2253, United States|Novo Nordisk Investigational Site, Decatur, Georgia, 30033, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Savannah, Georgia, 31405, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60616, United States|Novo Nordisk Investigational Site, Quincy, Illinois, 62301, United States|Novo Nordisk Investigational Site, Chicago Heights, Indiana, 60411, United States|Novo Nordisk Investigational Site, Louisville, Kentucky, 40213, United States|Novo Nordisk Investigational Site, Madisonville, Kentucky, 42431, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, 21204, United States|Novo Nordisk Investigational Site, Hyattsville, Maryland, 20782, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Methuen, Massachusetts, 01844, United States|Novo Nordisk Investigational Site, St. Louis, Missouri, 63104, United States|Novo Nordisk Investigational Site, Bronx, New York, 10461-2665, United States|Novo Nordisk Investigational Site, New Hyde Park, New York, 11042, United States|Novo Nordisk Investigational Site, Northport, New York, 11768, United States|Novo Nordisk Investigational Site, Syracuse, New York, 13210, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28277, United States|Novo Nordisk Investigational Site, Durham, North Carolina, 27710, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45226, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45245, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73103, United States|Novo Nordisk Investigational Site, Danville, Pennsylvania, 17822, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19152, United States|Novo Nordisk Investigational Site, State College, Pennsylvania, 16801, United States|Novo Nordisk Investigational Site, Willkes Barre, Pennsylvania, 18702, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Memphis, Tennessee, 38119, United States|Novo Nordisk Investigational Site, Corpus Christi, Texas, 78412, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75235-6233, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, Midland, Texas, 79707, United States|Novo Nordisk Investigational Site, Plano, Texas, 75075, United States|Novo Nordisk Investigational Site, Orem, Utah, 84058, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23249, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23294, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Bonheiden, 2820, Belgium|Novo Nordisk Investigational Site, Leuven, 3000, Belgium|Novo Nordisk Investigational Site, Edmonton, Alberta, T5J 3N4, Canada|Novo Nordisk Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Novo Nordisk Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada|Novo Nordisk Investigational Site, London, Ontario, N6G 2M1, Canada|Novo Nordisk Investigational Site, Mississauga, Ontario, L5M 2V8, Canada|Novo Nordisk Investigational Site, Smiths Falls, Ontario, K7A 4W8, Canada|Novo Nordisk Investigational Site, Ajax, L1S 7K8, Canada|Novo Nordisk Investigational Site, Antibes, 06600, France|Novo Nordisk Investigational Site, BRON cedex, 69677, France|Novo Nordisk Investigational Site, CAHORS cedex 9, 46005, France|Novo Nordisk Investigational Site, Corbeil Essonnes, 91106, France|Novo Nordisk Investigational Site, Haguenau, 67504, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, MARSEILLE cedex 08, 13285, France|Novo Nordisk Investigational Site, Marseille, 13008, France|Novo Nordisk Investigational Site, MONTPELLIER cedex 5, 34295, France|Novo Nordisk Investigational Site, Montpellier, 34070, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, Paris Cedex 10, 75475, France|Novo Nordisk Investigational Site, Paris, 75181, France|Novo Nordisk Investigational Site, PERPIGNAN cedex, 66046, France|Novo Nordisk Investigational Site, Pessac, 33600, France|Novo Nordisk Investigational Site, Poitiers, 86000, France|Novo Nordisk Investigational Site, Reims, 51056, France|Novo Nordisk Investigational Site, SAINT QUENTIN Cédex, 02321, France|Novo Nordisk Investigational Site, Saint-denis de La Reunion, 97405, France|Novo Nordisk Investigational Site, Saint-pierre de La Reunion, 97448, France|Novo Nordisk Investigational Site, Strasbourg, 67000, France|Novo Nordisk Investigational Site, Sète, 34200, France|Novo Nordisk Investigational Site, Tours, 37044, France|Novo Nordisk Investigational Site, Augsburg, 86150, Germany|Novo Nordisk Investigational Site, Bad Kreuznach, 55545, Germany|Novo Nordisk Investigational Site, Bad Mergentheim, 97980, Germany|Novo Nordisk Investigational Site, Bad Nauheim, 61231, Germany|Novo Nordisk Investigational Site, Berlin, 10789, Germany|Novo Nordisk Investigational Site, Berlin, 12163, Germany|Novo Nordisk Investigational Site, Berlin, 13055, Germany|Novo Nordisk Investigational Site, Bremen, 28213, Germany|Novo Nordisk Investigational Site, Dresden, 01219, Germany|Novo Nordisk Investigational Site, Dresden, 01307, Germany|Novo Nordisk Investigational Site, Duisburg, 47051, Germany|Novo Nordisk Investigational Site, Eisenach, 99817, Germany|Novo Nordisk Investigational Site, Erfurt, 99085, Germany|Novo Nordisk Investigational Site, Esslingen, 73728, Germany|Novo Nordisk Investigational Site, Frankfurt, 60388, Germany|Novo Nordisk Investigational Site, Freiburg, 79106, Germany|Novo Nordisk Investigational Site, Fulda, 36037, Germany|Novo Nordisk Investigational Site, Gifhorn, 38518, Germany|Novo Nordisk Investigational Site, Grevenbroich, 41515, Germany|Novo Nordisk Investigational Site, Hamburg, 21073, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Jena, 07743, Germany|Novo Nordisk Investigational Site, Leipzig, 04103, Germany|Novo Nordisk Investigational Site, Leipzig, 04275, Germany|Novo Nordisk Investigational Site, Limburg, 65549, Germany|Novo Nordisk Investigational Site, Mainz-Ebersheim, 55129, Germany|Novo Nordisk Investigational Site, Mainz, 55131, Germany|Novo Nordisk Investigational Site, Mannheim, 68163, Germany|Novo Nordisk Investigational Site, München, 81925, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Neuwied, 56564, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Rosenheim, 83022, Germany|Novo Nordisk Investigational Site, Schkeuditz, 04435, Germany|Novo Nordisk Investigational Site, Sinsheim, 74889, Germany|Novo Nordisk Investigational Site, St. Ingbert, 66386, Germany|Novo Nordisk Investigational Site, Stuttgart, 70184, Germany|Novo Nordisk Investigational Site, Wangen, 88239, Germany|Novo Nordisk Investigational Site, Ancona, 60100, Italy|Novo Nordisk Investigational Site, Caserta, 81100, Italy|Novo Nordisk Investigational Site, Catanzaro Lido, Italy|Novo Nordisk Investigational Site, Catanzaro, 88100, Italy|Novo Nordisk Investigational Site, Chiavari, 16043, Italy|Novo Nordisk Investigational Site, Cosenza, 87100, Italy|Novo Nordisk Investigational Site, Ferrara, Italy|Novo Nordisk Investigational Site, Lanciano, Italy|Novo Nordisk Investigational Site, Matera (mt), 75100, Italy|Novo Nordisk Investigational Site, Milano, 20162, Italy|Novo Nordisk Investigational Site, Milano, Italy|Novo Nordisk Investigational Site, Monserrato, Cagliari, 09042, Italy|Novo Nordisk Investigational Site, Monza, 20052, Italy|Novo Nordisk Investigational Site, Palermo, 90127, Italy|Novo Nordisk Investigational Site, Piacenza, 29100, Italy|Novo Nordisk Investigational Site, Primo Piano Palazzina Ambulato, 40133, Italy|Novo Nordisk Investigational Site, Ravenna, 48121, Italy|Novo Nordisk Investigational Site, Reggio Calabria, 89122, Italy|Novo Nordisk Investigational Site, Roma, 00133, Italy|Novo Nordisk Investigational Site, Terni, 05100, Italy|Novo Nordisk Investigational Site, Treviglio, Italy|Novo Nordisk Investigational Site, Amersfoort, 3816 CP, Netherlands|Novo Nordisk Investigational Site, Amsterdam, 1091 HA, Netherlands|Novo Nordisk Investigational Site, Amsterdam, 1105 AZ, Netherlands|Novo Nordisk Investigational Site, Beek, 6191JW, Netherlands|Novo Nordisk Investigational Site, Delft, 2625 AD, Netherlands|Novo Nordisk Investigational Site, Doetinchem, 7001 GW, Netherlands|Novo Nordisk Investigational Site, Eindhoven, 5616 GB, Netherlands|Novo Nordisk Investigational Site, Groningen, 9728 NT, Netherlands|Novo Nordisk Investigational Site, Heerlen, 6419 PC, Netherlands|Novo Nordisk Investigational Site, Hoofddorp, 2134 TM, Netherlands|Novo Nordisk Investigational Site, Hoogeveen, 7909 AA, Netherlands|Novo Nordisk Investigational Site, Leiden, 2334 CK, Netherlands|Novo Nordisk Investigational Site, Leiderdorp, 2352 RA, Netherlands|Novo Nordisk Investigational Site, Lichtenvoorde, 7131 CM, Netherlands|Novo Nordisk Investigational Site, Lieshout, 5737 CB, Netherlands|Novo Nordisk Investigational Site, Oude Pekela, 9665 AR, Netherlands|Novo Nordisk Investigational Site, Utrecht, 3584 CX, Netherlands|Novo Nordisk Investigational Site, Voorburg, 2275 CX, Netherlands|Novo Nordisk Investigational Site, Wildervank, 9648 BE, Netherlands|Novo Nordisk Investigational Site, Winschoten, 9671 CX, Netherlands|Novo Nordisk Investigational Site, Bayamon, 00961, Puerto Rico|Novo Nordisk Investigational Site, Carolina, 00983, Puerto Rico|Novo Nordisk Investigational Site, Trujillo Alto, 00976, Puerto Rico|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Badajoz, 06080, Spain|Novo Nordisk Investigational Site, Badalona, 08916, Spain|Novo Nordisk Investigational Site, Bilbao, 48013, Spain|Novo Nordisk Investigational Site, Cartagena, 30203, Spain|Novo Nordisk Investigational Site, Cádiz, 11009, Spain|Novo Nordisk Investigational Site, Córdoba, 14004, Spain|Novo Nordisk Investigational Site, Girona, 17007, Spain|Novo Nordisk Investigational Site, Granada, 18012, Spain|Novo Nordisk Investigational Site, Madrid, 28006, Spain|Novo Nordisk Investigational Site, Madrid, 28031, Spain|Novo Nordisk Investigational Site, Madrid, 28040, Spain|Novo Nordisk Investigational Site, Majadahonda, 28222, Spain|Novo Nordisk Investigational Site, Pamplona, 31008, Spain|Novo Nordisk Investigational Site, Pontevedra, 36001, Spain|Novo Nordisk Investigational Site, Pozuelo de Alarcon, 28223, Spain|Novo Nordisk Investigational Site, Salamanca, 37007, Spain|Novo Nordisk Investigational Site, San Juan, 03550, Spain|Novo Nordisk Investigational Site, San Sebastián de los Reyes, 28700, Spain|Novo Nordisk Investigational Site, Santa Cruz de Tenerife, 38010, Spain|Novo Nordisk Investigational Site, Sevilla, 41013, Spain|Novo Nordisk Investigational Site, Tarrasa, 08221, Spain|Novo Nordisk Investigational Site, Valencia, 46010, Spain|Novo Nordisk Investigational Site, Xátiva, 46800, Spain|Novo Nordisk Investigational Site, Zaragoza, 50009, Spain|Novo Nordisk Investigational Site, Aberdeen, AB25 1LD, United Kingdom|Novo Nordisk Investigational Site, Ashton-Under-Lyne, OL6 9RW, United Kingdom|Novo Nordisk Investigational Site, Bath, BA1 3NG, United Kingdom|Novo Nordisk Investigational Site, Belfast, BT12 6BA, United Kingdom|Novo Nordisk Investigational Site, Belfast, BT16 1RH, United Kingdom|Novo Nordisk Investigational Site, Belfast, BT41 2RL, United Kingdom|Novo Nordisk Investigational Site, Blackburn, BB2 3HH, United Kingdom|Novo Nordisk Investigational Site, Bradford, BD9 6RJ, United Kingdom|Novo Nordisk Investigational Site, Bristol, BS2 8HW, United Kingdom|Novo Nordisk Investigational Site, Coventry, CV2 2DX, United Kingdom|Novo Nordisk Investigational Site, Derby, DE22 3NE, United Kingdom|Novo Nordisk Investigational Site, Dundee, DD1 9SY, United Kingdom|Novo Nordisk Investigational Site, Edgbaston, Birmingham, B15 2TH, United Kingdom|Novo Nordisk Investigational Site, Edinburgh, EH4 2XU, United Kingdom|Novo Nordisk Investigational Site, Exeter, EX2 5AX, United Kingdom|Novo Nordisk Investigational Site, Guildford, GU2 7XX, United Kingdom|Novo Nordisk Investigational Site, Hull, HU3 2JZ, United Kingdom|Novo Nordisk Investigational Site, Inverness, IV2 3UJ, United Kingdom|Novo Nordisk Investigational Site, Leicester, LE1 5WW, United Kingdom|Novo Nordisk Investigational Site, Liverpool, L7 8XP, United Kingdom|Novo Nordisk Investigational Site, Liverpool, L9 7AL, United Kingdom|Novo Nordisk Investigational Site, Londonderry, BT47 6SB, United Kingdom|Novo Nordisk Investigational Site, London, E1 2EF, United Kingdom|Novo Nordisk Investigational Site, Manchester, M41 5SL, United Kingdom|Novo Nordisk Investigational Site, Manchester, M8 5RB, United Kingdom|Novo Nordisk Investigational Site, Northampton, NN1 5BD, United Kingdom|Novo Nordisk Investigational Site, Nuneaton, CV10 7DJ, United Kingdom|Novo Nordisk Investigational Site, Oxford, OX3 7LE, United Kingdom|Novo Nordisk Investigational Site, Rugby, CV22 5PX, United Kingdom|Novo Nordisk Investigational Site, Salford, M6 8HD, United Kingdom|Novo Nordisk Investigational Site, Swansea, SA6 6NL, United Kingdom|Novo Nordisk Investigational Site, Welwyn Garden City, AL7 4HQ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00856986

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details