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Clinical Trial Details

Trial ID: L2149
Source ID: NCT00789191
Associated Drug: Insulin Detemir
Title: Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00789191/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin detemir|DRUG: sitagliptin|DRUG: metformin|DRUG: sulphonylurea
Outcome Measures: Primary: HbA1c (Glycosylated Haemoglobin A1c), Week 26 | Secondary: Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%, Week 26|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia, Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia, Week 26|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%, Week 26|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia, Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia, Week 26|Change in BMI (Body Mass Index), Week 0, Week 26|Change in Body Weight, Week 0, Week 26|FPG (Fasting Plasma Glucose), Week 26|Hypoglycemic Episodes, Overall: All episodes. Minor: Symptomatic, with PG \< 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L, Weeks 0-26|Hypoglycemic Episodes: Day Time, Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG \< 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L, Weeks 0-26|Hypoglycemic Episodes: Night Time, Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG \< 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L, Weeks 0-26|Self-measured 9-point Plasma Glucose Profile, Week 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 222
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-11
Completion Date: 2009-08
Results First Posted: 2010-12-10
Last Update Posted: 2017-03-14
Locations: Novo Nordisk Investigational Site, Vestavia, Alabama, 35209, United States|Novo Nordisk Investigational Site, Orange, California, 92869, United States|Novo Nordisk Investigational Site, Santa Monica, California, 90404, United States|Novo Nordisk Investigational Site, Dunwoody, Georgia, 30338, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45245, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Norristown, Pennsylvania, 19401, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Coquitlam, British Columbia, V3K 3P4, Canada|Novo Nordisk Investigational Site, New Westminster, British Columbia, V3L 3W5, Canada|Novo Nordisk Investigational Site, St. John's, Newfoundland and Labrador, A1A 3R5, Canada|Novo Nordisk Investigational Site, Cambridge, Ontario, N1R 7L6, Canada|Novo Nordisk Investigational Site, Niagara Falls, Ontario, L2E 7H1, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M3J 1N2, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M9W 4L6, Canada|Novo Nordisk Investigational Site, Sherbrooke, Quebec, J1H 4J6, Canada|Novo Nordisk Investigational Site, St. Romuald, Quebec, G6W 5M6, Canada|Novo Nordisk Investigational Site, Niagara Falls, L2G 5X7, Canada|Novo Nordisk Investigational Site, Helsinki, FI-00350, Finland|Novo Nordisk Investigational Site, Loimaa, FI-32200, Finland|Novo Nordisk Investigational Site, Oulu, FI-90220, Finland|Novo Nordisk Investigational Site, Pieksämäki, 76100, Finland|Novo Nordisk Investigational Site, Pori, FI-28100, Finland|Novo Nordisk Investigational Site, Seinäjoki, FI-60100, Finland|Novo Nordisk Investigational Site, Brest, 29200, France|Novo Nordisk Investigational Site, LA ROCHE-sur-YON cedex 9, 85295, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, Lille, 59037, France|Novo Nordisk Investigational Site, Montigny-les-Metz, 57950, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, Roubaix, 59100, France|Novo Nordisk Investigational Site, Budapest, 1083, Hungary|Novo Nordisk Investigational Site, Budapest, 1125, Hungary|Novo Nordisk Investigational Site, Budapest, H-1212, Hungary|Novo Nordisk Investigational Site, Eger, 3300, Hungary|Novo Nordisk Investigational Site, Pécs, 7623, Hungary|Novo Nordisk Investigational Site, Daegu, 705-717, Korea, Republic of|Novo Nordisk Investigational Site, Incheon, 400-103, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 135-239, Korea, Republic of|Novo Nordisk Investigational Site, Bratislava, 831 01, Slovakia|Novo Nordisk Investigational Site, Bratislava, 851 01, Slovakia|Novo Nordisk Investigational Site, Kosice, 040 01, Slovakia|Novo Nordisk Investigational Site, Lucenec, 98401, Slovakia|Novo Nordisk Investigational Site, Presov, 080 01, Slovakia|Novo Nordisk Investigational Site, Zilina, 01001, Slovakia|Novo Nordisk Investigational Site, Ankara, 06100, Turkey|Novo Nordisk Investigational Site, Istanbul, 34098, Turkey|Novo Nordisk Investigational Site, Istanbul, 34390, Turkey|Novo Nordisk Investigational Site, Kocaeli, 41380, Turkey
URL: https://clinicaltrials.gov/show/NCT00789191

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