Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5279
Source ID: NCT00949442
Associated Drug: Insulin Glargine (Hoe901) [Lantus]
Title: Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment
Acronym: LANCELOT
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin Glargine (HOE901) [Lantus]|DRUG: Glimepiride|DRUG: human insulin [NPH]
Outcome Measures: Primary: HbA1c, Recorded at baseline (week 0), week 12, week 24 and week 36 | Secondary: Self-monitored fasting plasma glucose (FPG), Before baseline (week 0), weeks 12, 24 and 36|8-points profiles, The week before baseline, at 12, 24 and 36 weeks|Episodes of hypoglycemia, From the week -2 to the week 36|Daily doses of insulin, At week 1, week 2, week 3, week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 20, week 24, week 28, week 32, week 36|Need of additional prandial insulin, At week 24
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 708
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-07
Completion Date: 2012-07
Results First Posted:
Last Update Posted: 2012-08-21
Locations: Investigational Site Number 076-001, Fortaleza, 60115-282, Brazil|Investigational Site Number 076-006, Fortaleza, 60430-370, Brazil|Investigational Site Number 076-005, Porto Alegre, 90035-170, Brazil|Investigational Site Number 076-007, Rio de Janeiro, 202110340, Brazil|Investigational Site Number 076-004, São Paulo, 01221-000, Brazil|Investigational Site Number 076-003, São Paulo, 01244-030, Brazil|Investigational Site Number 076-002, São Paulo, 04024-002, Brazil|Investigational Site Number 203003, Beroun, 26601, Czech Republic|Investigational Site Number 203008, Ceske Budejovice, 37001, Czech Republic|Investigational Site Number 203011, Ceske Budejovice, 37007, Czech Republic|Investigational Site Number 203001, Chrudim III, 53701, Czech Republic|Investigational Site Number 203006, Hodonin, 69501, Czech Republic|Investigational Site Number 203002, Hranice I - Mesto, 75301, Czech Republic|Investigational Site Number 203010, Liberec, 46001, Czech Republic|Investigational Site Number 203009, Moravsky Pisek, 39701, Czech Republic|Investigational Site Number 203004, Praha 10, 10000, Czech Republic|Investigational Site Number 203005, Praha 10, 10000, Czech Republic|Investigational Site Number 203007, Praha 6, 16300, Czech Republic|Investigational Site Number 818001, Menoufiya, Egypt|Investigational Site Number 250-002, Aix En Provence, 13100, France|Investigational Site Number 250-001, Antibes, 06600, France|Investigational Site Number 250-005, Bordeaux, 33200, France|Investigational Site Number 250-004, Jarny, 54800, France|Investigational Site Number 250-003, NARBONNE Cedex, 11018, France|Investigational Site Number 250-006, Strasbourg, 67000, France|Investigational Site Number 380001, Perugia, 06156, Italy|Investigational Site Number 410005, Daegu, Korea, Republic of|Investigational Site Number 410002, Gyeonggi-Do, 420-717, Korea, Republic of|Investigational Site Number 410006, Incheon, 400-711, Korea, Republic of|Investigational Site Number 410001, Seoul, 137-701, Korea, Republic of|Investigational Site Number 410003, Seoul, Korea, Republic of|Investigational Site Number 410004, Seoul, Korea, Republic of|Investigational Site Number 414001, Kuwait, Kuwait|Investigational Site Number 484003, Guadalajara, 44150, Mexico|Investigational Site Number 484005, Guadalajara, 44650, Mexico|Investigational Site Number 484001, Monterrey, 64710, Mexico|Investigational Site Number 484008, Pachuca, 042090, Mexico|Investigational Site Number 484009, Pachuca, 42086, Mexico|Investigational Site Number 484002, Puebla, 72190, Mexico|Investigational Site Number 528006, Almelo, 7600SZ, Netherlands|Investigational Site Number 528005, Apeldoorn, 7314 ET, Netherlands|Investigational Site Number 528001, Beek, 6191JW, Netherlands|Investigational Site Number 528002, Hoogeveen, 7909AA, Netherlands|Investigational Site Number 528004, Hoogezand, 9603AE, Netherlands|Investigational Site Number 528003, Rotterdam, 3053CD, Netherlands|Investigational Site Number 616004, Gdansk, 80-211, Poland|Investigational Site Number 616003, Kraków, 31-262, Poland|Investigational Site Number 616002, Lublin, 20-954, Poland|Investigational Site Number 616001, Zabrze, 41-800, Poland|Investigational Site Number 642001, Bucharest, Romania|Investigational Site Number 642002, Bucharest, Romania|Investigational Site Number 642009, Cluj-Napoca, Romania|Investigational Site Number 642003, Craiova, Romania|Investigational Site Number 642005, Iasi, Romania|Investigational Site Number 642010, Oradea, Romania|Investigational Site Number 642011, Oradea, Romania|Investigational Site Number 642007, Ploiesti, Romania|Investigational Site Number 642004, Resita, Romania|Investigational Site Number 642008, Targu-Mures, Romania|Investigational Site Number 642012, Timisoara, Romania|Investigational Site Number 643-001, Moscow, Russian Federation|Investigational Site Number 643-006, Samara, Russian Federation|Investigational Site Number 643-005, Saratov, Russian Federation|Investigational Site Number 643-002, St-Petersburg, 195257, Russian Federation|Investigational Site Number 643-003, St-Petersburg, Russian Federation|Investigational Site Number 643-004, St-Ptetersburg, 194354, Russian Federation|Investigational Site Number 643-007, Tyumen, 625046, Russian Federation|Investigational Site Number 703005, Banská Bystrica, 97517, Slovakia|Investigational Site Number 703003, Bratislava, 81102, Slovakia|Investigational Site Number 703007, Bratislava, 82606, Slovakia|Investigational Site Number 703004, Kosice, 04001, Slovakia|Investigational Site Number 703006, Kosice, 04001, Slovakia|Investigational Site Number 703002, Kosice, 04011, Slovakia|Investigational Site Number 703008, Levice, 93401, Slovakia|Investigational Site Number 703001, Martin, 03659, Slovakia|Investigational Site Number 752004, Lund, 22361, Sweden|Investigational Site Number 752002, Malmö, 21120, Sweden|Investigational Site Number 752003, Skene, 51162, Sweden|Investigational Site Number 752001, Stockholm, 17176, Sweden|Investigational Site Number 756001, Geneve, 1205, Switzerland|Investigational Site Number 764004, Bangkok, 10330, Thailand|Investigational Site Number 764001, Bangkok, 10400, Thailand|Investigational Site Number 764002, Chiangmai, 50002, Thailand|Investigational Site Number 764003, Khon Kaen, 40002, Thailand|Investigational Site Number 764006, Nakhonratchasima, 30000, Thailand|Investigational Site Number 764005, Pathumthani, 12120, Thailand|Investigational Site Number 784-001, Dubai, 4545, United Arab Emirates
URL: https://clinicaltrials.gov/show/NCT00949442

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress