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Clinical Trial Details

Trial ID: L6655
Source ID: NCT00318461
Associated Drug: Liraglutide
Title: To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Acronym: LEAD-2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00318461/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: liraglutide|DRUG: metformin|DRUG: glimepiride|DRUG: placebo|DRUG: placebo|DRUG: liraglutide|DRUG: liraglutide
Outcome Measures: Primary: Change in Glycosylated A1c (HbA1c) at Week 26, Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Glycosylated A1c (HbA1c) at Week 104, Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation), week 0, week 104 | Secondary: Change in Body Weight at Week 26, Change in body weight from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Body Weight at Week 104, Change in body weight from baseline (week 0) to 104 weeks (end of treatment), week 0, week 104|Change in Fasting Plasma Glucose (FPG) at Week 26, Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation), week 0, week 26|Change in Fasting Plasma Glucose (FPG) at Week 104, Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment), week 0, week 104|Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26, Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three., week 0, week 26|Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104, Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three., week 0, week 104|Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26, Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three., week 0, week 26|Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104, Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three., week 0, week 104|Change in Beta-cell Function at Week 26, Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5)., week 0, week 26|Change in Beta-cell Function at Week 104, Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5)., week 0, week 104|Hypoglycaemic Episodes at Week 26, Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., weeks 0-26|Hypoglycaemic Episodes at Week 104, Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., weeks 0-104
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1091
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-05
Completion Date: 2008-11
Results First Posted: 2010-03-12
Last Update Posted: 2017-03-07
Locations: Novo Nordisk Investigational Site, Ciudad Autonoma de Bs As, C1405CWB, Argentina|Novo Nordisk Investigational Site, Ciudad Autónoma de Bs As, C1426ABP, Argentina|Novo Nordisk Investigational Site, Ciudad Autónoma de BsAs, C1406FWY, Argentina|Novo Nordisk Investigational Site, Junín, 6000, Argentina|Novo Nordisk Investigational Site, Broadmeadow, New South Wales, 2292, Australia|Novo Nordisk Investigational Site, Penrith, New South Wales, 2751, Australia|Novo Nordisk Investigational Site, St Leonards, New South Wales, 2065, Australia|Novo Nordisk Investigational Site, Daw Park, South Australia, 5041, Australia|Novo Nordisk Investigational Site, East Ringwood, Victoria, 3135, Australia|Novo Nordisk Investigational Site, Fremantle, Western Australia, 6160, Australia|Novo Nordisk Investigational Site, Adelaide, 5000, Australia|Novo Nordisk Investigational Site, Adelaide, SA 5035, Australia|Novo Nordisk Investigational Site, Auckland, Australia|Novo Nordisk Investigational Site, Bankstown, 2200, Australia|Novo Nordisk Investigational Site, Box Hill, 3128, Australia|Novo Nordisk Investigational Site, Cairns, 4870, Australia|Novo Nordisk Investigational Site, Camperdown, 2050, Australia|Novo Nordisk Investigational Site, Christchurch, 8011, Australia|Novo Nordisk Investigational Site, Clayton, 3168, Australia|Novo Nordisk Investigational Site, Fitzroy, 3065, Australia|Novo Nordisk Investigational Site, Garran, 2605, Australia|Novo Nordisk Investigational Site, Hornsby, 2077, Australia|Novo Nordisk Investigational Site, Malvern, 3144, Australia|Novo Nordisk Investigational Site, Perth, 6000, Australia|Novo Nordisk Investigational Site, Westmead, 2145, Australia|Novo Nordisk Investigational Site, Woodville, 5011, Australia|Novo Nordisk Investigational Site, Arlon, 6700, Belgium|Novo Nordisk Investigational Site, Bonheiden, 2820, Belgium|Novo Nordisk Investigational Site, Gent, 9000, Belgium|Novo Nordisk Investigational Site, Huy, 4500, Belgium|Novo Nordisk Investigational Site, La Louvière, 7100, Belgium|Novo Nordisk Investigational Site, Leuven, 3000, Belgium|Novo Nordisk Investigational Site, Sofia, 1431, Bulgaria|Novo Nordisk Investigational Site, Zagreb, 10 000, Croatia|Novo Nordisk Investigational Site, Aalborg, 9000, Denmark|Novo Nordisk Investigational Site, Frederiksberg, 2000, Denmark|Novo Nordisk Investigational Site, Herlev, 2730, Denmark|Novo Nordisk Investigational Site, Hjørring, 9800, Denmark|Novo Nordisk Investigational Site, Hvidovre, 2650, Denmark|Novo Nordisk Investigational Site, København S, 2300, Denmark|Novo Nordisk Investigational Site, København, 2400, Denmark|Novo Nordisk Investigational Site, Odense, 5000, Denmark|Novo Nordisk Investigational Site, Viborg, Denmark|Novo Nordisk Investigational Site, Århus C, 8000, Denmark|Novo Nordisk Investigational Site, Aschaffenburg, 63739, Germany|Novo Nordisk Investigational Site, Bad Heilbrunn, 83670, Germany|Novo Nordisk Investigational Site, Bad Kreuznach, 55545, Germany|Novo Nordisk Investigational Site, Bad Lauterberg, 37431, Germany|Novo Nordisk Investigational Site, Bad Mergentheim, 97980, Germany|Novo Nordisk Investigational Site, Bad Neuenahr-Ahrweiler, 53474, Germany|Novo Nordisk Investigational Site, Beckum, 59269, Germany|Novo Nordisk Investigational Site, Bensheim, 64625, Germany|Novo Nordisk Investigational Site, Berlin, 10115, Germany|Novo Nordisk Investigational Site, Berlin, 12203, Germany|Novo Nordisk Investigational Site, Berlin, 12687, Germany|Novo Nordisk Investigational Site, Darmstadt, 64283, Germany|Novo Nordisk Investigational Site, Diez, 65582, Germany|Novo Nordisk Investigational Site, Dormagen, 41539, Germany|Novo Nordisk Investigational Site, Dresden, 01219, Germany|Novo Nordisk Investigational Site, Dresden, 01307, Germany|Novo Nordisk Investigational Site, Flensburg, 24939, Germany|Novo Nordisk Investigational Site, Großheirath, 96269, Germany|Novo Nordisk Investigational Site, Halle, 06114, Germany|Novo Nordisk Investigational Site, Hamburg, 21073, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Kutenholz-Mulsum, 27449, Germany|Novo Nordisk Investigational Site, Köln, 50858, Germany|Novo Nordisk Investigational Site, Ludwigshafen, 67059, Germany|Novo Nordisk Investigational Site, Marburg, 35037, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Neuwied, 56564, Germany|Novo Nordisk Investigational Site, Oberhausen, 46145, Germany|Novo Nordisk Investigational Site, Pirna, 01796, Germany|Novo Nordisk Investigational Site, Pohlheim, 35415, Germany|Novo Nordisk Investigational Site, Regensburg, 93059, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Saaldorf-Surheim, 83416, Germany|Novo Nordisk Investigational Site, Saarbrücken, 66121, Germany|Novo Nordisk Investigational Site, Speyer, 67346, Germany|Novo Nordisk Investigational Site, St. Ingbert, 66386, Germany|Novo Nordisk Investigational Site, Stuttgart, 70184, Germany|Novo Nordisk Investigational Site, Sulzbach-Rosenberg, 92237, Germany|Novo Nordisk Investigational Site, Tübingen, 72072, Germany|Novo Nordisk Investigational Site, Viersen, 41751, Germany|Novo Nordisk Investigational Site, Völklingen, 66333, Germany|Novo Nordisk Investigational Site, Würzburg, 97072, Germany|Novo Nordisk Investigational Site, Budapest, 1041, Hungary|Novo Nordisk Investigational Site, Debrecen, 4043, Hungary|Novo Nordisk Investigational Site, Gyula, 5700, Hungary|Novo Nordisk Investigational Site, Nyíregyháza, 4400, Hungary|Novo Nordisk Investigational Site, Pecs, 7631, Hungary|Novo Nordisk Investigational Site, Szekszárd, 7100, Hungary|Novo Nordisk Investigational Site, Zalaegerszeg, 8900, Hungary|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500082, India|Novo Nordisk Investigational Site, Kochi, Kerala, 682041, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400012, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600086, India|Novo Nordisk Investigational Site, Bangalore, 560034, India|Novo Nordisk Investigational Site, Dublin, DUBLIN 15, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 7, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 8, Ireland|Novo Nordisk Investigational Site, Waterford, Ireland|Novo Nordisk Investigational Site, Bari, 70124, Italy|Novo Nordisk Investigational Site, Catania, 95126, Italy|Novo Nordisk Investigational Site, Firenze, 50141, Italy|Novo Nordisk Investigational Site, Milano, 20122, Italy|Novo Nordisk Investigational Site, Milano, 20132, Italy|Novo Nordisk Investigational Site, Monza, 20052, Italy|Novo Nordisk Investigational Site, Orbassano, 10043, Italy|Novo Nordisk Investigational Site, Padova, 35128, Italy|Novo Nordisk Investigational Site, Palermo, 90127, Italy|Novo Nordisk Investigational Site, Rimini, 47900, Italy|Novo Nordisk Investigational Site, Roma, 00161, Italy|Novo Nordisk Investigational Site, Sassari, 07100, Italy|Novo Nordisk Investigational Site, Torino, 10154, Italy|Novo Nordisk Investigational Site, Verona, 37126, Italy|Novo Nordisk Investigational Site, Apeldoorn, 7334 DZ, Netherlands|Novo Nordisk Investigational Site, Groningen, 9728 NT, Netherlands|Novo Nordisk Investigational Site, Rotterdam, 3045 PM, Netherlands|Novo Nordisk Investigational Site, Sliedrecht, 3361 XV, Netherlands|Novo Nordisk Investigational Site, Bekkestua, 1357, Norway|Novo Nordisk Investigational Site, Bergen, NO-5012, Norway|Novo Nordisk Investigational Site, Elverum, 2408, Norway|Novo Nordisk Investigational Site, Gjøvik, NO-2819, Norway|Novo Nordisk Investigational Site, Hamar, 2317, Norway|Novo Nordisk Investigational Site, Kongsberg, NO-3602, Norway|Novo Nordisk Investigational Site, Kongsvinger, 2212, Norway|Novo Nordisk Investigational Site, Stavanger, 4011, Norway|Novo Nordisk Investigational Site, Tromsø, 9038, Norway|Novo Nordisk Investigational Site, Trondheim, NO-7030, Norway|Novo Nordisk Investigational Site, Cluj Napoca, Cluj, 400006, Romania|Novo Nordisk Investigational Site, Constanta, 900591, Romania|Novo Nordisk Investigational Site, Iasi, 700111, Romania|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Moscow, 119435, Russian Federation|Novo Nordisk Investigational Site, Moscow, 127486, Russian Federation|Novo Nordisk Investigational Site, Moscow, 129090, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194354, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 198013, Russian Federation|Novo Nordisk Investigational Site, Bratislava, 83 299, Slovakia|Novo Nordisk Investigational Site, Bratislava, 831 01, Slovakia|Novo Nordisk Investigational Site, Bratislava, 833 05, Slovakia|Novo Nordisk Investigational Site, Kosice, 04-001, Slovakia|Novo Nordisk Investigational Site, Moldava nad Bodvou, 045 01, Slovakia|Novo Nordisk Investigational Site, Presov, 080 01, Slovakia|Novo Nordisk Investigational Site, Trencin, 91 101, Slovakia|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1829, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 27 11, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4001, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4091, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4092, South Africa|Novo Nordisk Investigational Site, Cape Town, Western Cape, 7130, South Africa|Novo Nordisk Investigational Site, Benoni, 1500, South Africa|Novo Nordisk Investigational Site, Alcazar de San Juan, 13600, Spain|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Barcelona, 08017, Spain|Novo Nordisk Investigational Site, Bilbao, 48013, Spain|Novo Nordisk Investigational Site, Cádiz, 11009, Spain|Novo Nordisk Investigational Site, Girona, 17007, Spain|Novo Nordisk Investigational Site, Granada, 18012, Spain|Novo Nordisk Investigational Site, La Coruña, 15006, Spain|Novo Nordisk Investigational Site, La Laguna, 38320, Spain|Novo Nordisk Investigational Site, Málaga, 29010, Spain|Novo Nordisk Investigational Site, Mérida, 06800, Spain|Novo Nordisk Investigational Site, San Juan, 03550, Spain|Novo Nordisk Investigational Site, Santa Cruz de Tenerife, 38010, Spain|Novo Nordisk Investigational Site, Santander, 39008, Spain|Novo Nordisk Investigational Site, Sevilla, 41009, Spain|Novo Nordisk Investigational Site, Falun, 791 82, Sweden|Novo Nordisk Investigational Site, Karlstad, 651 85, Sweden|Novo Nordisk Investigational Site, Linköping, 581 85, Sweden|Novo Nordisk Investigational Site, Lund, 221 85, Sweden|Novo Nordisk Investigational Site, Malmö, 205 02, Sweden|Novo Nordisk Investigational Site, Stockholm, 118 83, Sweden|Novo Nordisk Investigational Site, Stockholm, 171 76, Sweden|Novo Nordisk Investigational Site, Umeå, 901 85, Sweden|Novo Nordisk Investigational Site, Abergavenny, NP7 7EG, United Kingdom|Novo Nordisk Investigational Site, Bath, BA1 2SR, United Kingdom|Novo Nordisk Investigational Site, Bath, BA2 1NH, United Kingdom|Novo Nordisk Investigational Site, Berkshire, RG7 3SQ, United Kingdom|Novo Nordisk Investigational Site, Cardiff, CF23 8SQ, United Kingdom|Novo Nordisk Investigational Site, Coventry, CV2 2DX, United Kingdom|Novo Nordisk Investigational Site, Dundee, DD1 9SY, United Kingdom|Novo Nordisk Investigational Site, East Horsley, KT24 6QT, United Kingdom|Novo Nordisk Investigational Site, Frome, BA11 1EZ, United Kingdom|Novo Nordisk Investigational Site, Llanelli, SA14 8QF, United Kingdom|Novo Nordisk Investigational Site, Oxford, OX3 7LE, United Kingdom|Novo Nordisk Investigational Site, Plymouth, PL6 8BQ, United Kingdom|Novo Nordisk Investigational Site, Sheffield, S3 9DA, United Kingdom|Novo Nordisk Investigational Site, Sunbury on Thames, TW16 6RH, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00318461

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