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Clinical Trial Details

Trial ID: L2902
Source ID: NCT01620489
Associated Drug: Liraglutide
Title: Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01620489/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: liraglutide|DRUG: placebo
Outcome Measures: Primary: Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin), Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model., Week 0, Week 26 | Secondary: Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment, Calculated as estimated percentage of subjects achieving HbA1c \<7.0% and no weight gain after 26 weeks of treatment based on the statistical model., At week 26|Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment, Calculated as estimated percentage of subjects achieving HbA1c \<7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model., At week 26|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles, SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model., Week 0, week 26|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI), Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model., Week 0, week 26|Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula), Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model., Week 0, week 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 279
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-06-14
Completion Date: 2013-08-20
Results First Posted: 2014-10-30
Last Update Posted: 2019-03-19
Locations: Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, La Jolla, California, 92037, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Monterey, California, 93940, United States|Novo Nordisk Investigational Site, San Diego, California, 92111, United States|Novo Nordisk Investigational Site, San Ramon, California, 94583, United States|Novo Nordisk Investigational Site, Torrance, California, 90502, United States|Novo Nordisk Investigational Site, Tustin, California, 92780, United States|Novo Nordisk Investigational Site, Ventura, California, 93003, United States|Novo Nordisk Investigational Site, Golden, Colorado, 80401, United States|Novo Nordisk Investigational Site, Boynton Beach, Florida, 33472, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33027, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, Saint Petersburg, Florida, 33711, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30303, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Avon, Indiana, 46123, United States|Novo Nordisk Investigational Site, Franklin, Indiana, 46131, United States|Novo Nordisk Investigational Site, Greenfield, Indiana, 46140, United States|Novo Nordisk Investigational Site, Muncie, Indiana, 47304, United States|Novo Nordisk Investigational Site, Slidell, Louisiana, 70461-4231, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Springfield, Massachusetts, 01199, United States|Novo Nordisk Investigational Site, Buckley, Michigan, 49620, United States|Novo Nordisk Investigational Site, Southfield, Michigan, 48034-7661, United States|Novo Nordisk Investigational Site, Great Falls, Montana, 59405, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Rosedale, New York, 11422, United States|Novo Nordisk Investigational Site, Staten Island, New York, 10301, United States|Novo Nordisk Investigational Site, Greenville, North Carolina, 27834, United States|Novo Nordisk Investigational Site, Mooresville, North Carolina, 28117, United States|Novo Nordisk Investigational Site, Franklin, Ohio, 45005, United States|Novo Nordisk Investigational Site, Mason, Ohio, 45040-6815, United States|Novo Nordisk Investigational Site, Wadsworth, Ohio, 44281-9236, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73104, United States|Novo Nordisk Investigational Site, McMurray, Pennsylvania, 15317, United States|Novo Nordisk Investigational Site, Norristown, Pennsylvania, 19401, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19107, United States|Novo Nordisk Investigational Site, East Providence, Rhode Island, 02914, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404-1192, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Lubbock, Texas, 79423, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77479, United States|Novo Nordisk Investigational Site, Newport News, Virginia, 23606, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23219, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23294, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23298, United States|Novo Nordisk Investigational Site, Winchester, Virginia, 22601, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Brest, 29609, France|Novo Nordisk Investigational Site, LA ROCHE-sur-YON cedex 9, 85295, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Pointe À Pitre, 97159, France|Novo Nordisk Investigational Site, Strasbourg, 67000, France|Novo Nordisk Investigational Site, Bialystok, 15-381, Poland|Novo Nordisk Investigational Site, Bialystok, 15-435, Poland|Novo Nordisk Investigational Site, Gdansk, 80-546, Poland|Novo Nordisk Investigational Site, Katowice, 40-767, Poland|Novo Nordisk Investigational Site, Krakow, 31-261, Poland|Novo Nordisk Investigational Site, Poznan, 60-111, Poland|Novo Nordisk Investigational Site, Poznan, 60-569, Poland|Novo Nordisk Investigational Site, Zabrze, 41-800, Poland|Novo Nordisk Investigational Site, Barnaul, 656045, Russian Federation|Novo Nordisk Investigational Site, Kazan, 420043, Russian Federation|Novo Nordisk Investigational Site, Kursk, 305035, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Moscow, 123448, Russian Federation|Novo Nordisk Investigational Site, Moscow, 127411, Russian Federation|Novo Nordisk Investigational Site, Nizhniy Novgorod, 603126, Russian Federation|Novo Nordisk Investigational Site, Penza, 440026, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194358, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 195257, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 199034, Russian Federation|Novo Nordisk Investigational Site, Samara, 443067, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410031, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410039, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410053, Russian Federation|Novo Nordisk Investigational Site, Smolensk, 214019, Russian Federation|Novo Nordisk Investigational Site, Volgograd, 400138, Russian Federation|Novo Nordisk Investigational Site, Kharkiv, 61000, Ukraine|Novo Nordisk Investigational Site, Kiev, 04053, Ukraine|Novo Nordisk Investigational Site, Kyiv, 04114, Ukraine|Novo Nordisk Investigational Site, Vinnytsia, 21010, Ukraine|Novo Nordisk Investigational Site, Zaporizhia, 69600, Ukraine|Novo Nordisk Investigational Site, Bristol, BS10 5NB, United Kingdom|Novo Nordisk Investigational Site, Dundee, DD1 9SY, United Kingdom|Novo Nordisk Investigational Site, Edinburgh, EH4 2XU, United Kingdom|Novo Nordisk Investigational Site, Hull, HU3 2RW, United Kingdom|Novo Nordisk Investigational Site, Leicester, LE5 4PW, United Kingdom|Novo Nordisk Investigational Site, Letchworth, SG6 4UB, United Kingdom|Novo Nordisk Investigational Site, London, E1 2EF, United Kingdom|Novo Nordisk Investigational Site, London, SE5 9RT, United Kingdom|Novo Nordisk Investigational Site, Swansea, SA6 6NL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01620489

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress