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Clinical Trial Details

Trial ID: L7159
Source ID: NCT01907854
Associated Drug: Liraglutide
Title: Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin
Acronym: LIRA-SWITCH™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01907854/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: liraglutide|DRUG: sitagliptin|DRUG: placebo|DRUG: placebo
Outcome Measures: Primary: Change in HbA1c (Glycosylated Haemoglobin), Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM)., From baseline to week 26 | Secondary: Change in Body Weight, Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM., From baseline to week 26|Change in Fasting Plasma Glucose, Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM., From baseline to week 26|Change in Fasting Blood Lipids, Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein \[LDL\], very low density lipoprotein \[VLDL\], high density lipoprotein \[HDL\], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data., From baseline to week 26|Change in Systolic Blood Pressure and Diastolic Blood Pressure, Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM., From baseline to week 26|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n), Number of subjects who achieve HbA1c \<7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM., After 26 weeks of treatment|Number of Treatment Emergent Adverse Events (TEAEs), A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period., During 26 weeks of treatment plus one week follow-up period.
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 407
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-12-02
Completion Date: 2015-06-15
Results First Posted: 2016-07-01
Last Update Posted: 2018-10-02
Locations: Novo Nordisk Investigational Site, Phoenix, Arizona, 85018, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85027, United States|Novo Nordisk Investigational Site, Tucson, Arizona, 85704, United States|Novo Nordisk Investigational Site, Tucson, Arizona, 85724, United States|Novo Nordisk Investigational Site, Escondido, California, 92025, United States|Novo Nordisk Investigational Site, Mission Viejo, California, 92691, United States|Novo Nordisk Investigational Site, Roseville, California, 95661, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80909, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80922, United States|Novo Nordisk Investigational Site, Chiefland, Florida, 32626, United States|Novo Nordisk Investigational Site, Fort Lauderdale, Florida, 33308, United States|Novo Nordisk Investigational Site, Hialeah, Florida, 33012, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32207, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32258, United States|Novo Nordisk Investigational Site, Miami, Florida, 33183, United States|Novo Nordisk Investigational Site, North Miami, Florida, 33181, United States|Novo Nordisk Investigational Site, Port Charlotte, Florida, 33952, United States|Novo Nordisk Investigational Site, Johns Creek, Georgia, 30097, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Blackfoot, Idaho, 83221, United States|Novo Nordisk Investigational Site, Arlington Heights, Illinois, 60005-4144, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60604, United States|Novo Nordisk Investigational Site, Peoria, Illinois, 61602, United States|Novo Nordisk Investigational Site, Skokie, Illinois, 60077, United States|Novo Nordisk Investigational Site, Avon, Indiana, 46123, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47714, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47725, United States|Novo Nordisk Investigational Site, Council Bluffs, Iowa, 51501, United States|Novo Nordisk Investigational Site, Bangor, Maine, 04401, United States|Novo Nordisk Investigational Site, Fall River, Massachusetts, 02720, United States|Novo Nordisk Investigational Site, Troy, Michigan, 48085-5524, United States|Novo Nordisk Investigational Site, Saint Peters, Missouri, 63376, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89119, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Berlin, New Jersey, 08009, United States|Novo Nordisk Investigational Site, Elizabeth, New Jersey, 07202, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28210, United States|Novo Nordisk Investigational Site, Salisbury, North Carolina, 28144, United States|Novo Nordisk Investigational Site, Akron, Ohio, 44311, United States|Novo Nordisk Investigational Site, Reading, Pennsylvania, 19606, United States|Novo Nordisk Investigational Site, Moncks Corner, South Carolina, 29461, United States|Novo Nordisk Investigational Site, Orangeburg, South Carolina, 29118, United States|Novo Nordisk Investigational Site, Memphis, Tennessee, 38119, United States|Novo Nordisk Investigational Site, Edinburg, Texas, 78539, United States|Novo Nordisk Investigational Site, Fort Worth, Texas, 76104, United States|Novo Nordisk Investigational Site, Houston, Texas, 77024, United States|Novo Nordisk Investigational Site, Houston, Texas, 77030, United States|Novo Nordisk Investigational Site, Houston, Texas, 77036, United States|Novo Nordisk Investigational Site, Houston, Texas, 77079, United States|Novo Nordisk Investigational Site, Midland, Texas, 79707, United States|Novo Nordisk Investigational Site, New Braunfels, Texas, 78130, United States|Novo Nordisk Investigational Site, North Richland Hills, Texas, 76180, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78245, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Virginia Beach, Virginia, 23454, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99202-3649, United States|Novo Nordisk Investigational Site, Surrey, British Columbia, V3S 2N6, Canada|Novo Nordisk Investigational Site, Brampton, Ontario, L6S 0C6, Canada|Novo Nordisk Investigational Site, Burlington, Ontario, L7M 4Y1, Canada|Novo Nordisk Investigational Site, Concord, Ontario, L4K 4M2, Canada|Novo Nordisk Investigational Site, Etobicoke, Ontario, M9R 4E1, Canada|Novo Nordisk Investigational Site, Grimsby, Ontario, L3M 1P3, Canada|Novo Nordisk Investigational Site, Ottawa, Ontario, K1K 4L2, Canada|Novo Nordisk Investigational Site, Sarnia, Ontario, N7T 4X3, Canada|Novo Nordisk Investigational Site, Strathroy, Ontario, N7G 1Y7, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M3J 1N2, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M4G 3E8, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M9V 4B4, Canada|Novo Nordisk Investigational Site, Drummondville, Quebec, J2B 7T1, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, H4A 3T2, Canada|Novo Nordisk Investigational Site, St. Romuald, Quebec, G6W 5M6, Canada|Novo Nordisk Investigational Site, Trois Rivières, Quebec, G8T 7A1, Canada|Novo Nordisk Investigational Site, Quebec, G3K 2P8, Canada|Novo Nordisk Investigational Site, Budapest, 1042, Hungary|Novo Nordisk Investigational Site, Debrecen, 4043, Hungary|Novo Nordisk Investigational Site, Eger, 3300, Hungary|Novo Nordisk Investigational Site, Gyula, H-5700, Hungary|Novo Nordisk Investigational Site, Salgótarján, 3100, Hungary|Novo Nordisk Investigational Site, Sopron, 9400, Hungary|Novo Nordisk Investigational Site, Szeged, H-6720, Hungary|Novo Nordisk Investigational Site, Tatabánya, 2800, Hungary|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500082, India|Novo Nordisk Investigational Site, Visakhapatnam, Andhra Pradesh, 530002, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380008, India|Novo Nordisk Investigational Site, Gandhinagar, Gujarat, 382428, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560002, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400007, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411040, India|Novo Nordisk Investigational Site, New Delhi, 110060, India|Novo Nordisk Investigational Site, Haifa, 3339419, Israel|Novo Nordisk Investigational Site, Haifa, 35152, Israel|Novo Nordisk Investigational Site, Herzliya, 46851, Israel|Novo Nordisk Investigational Site, Kfar Saba, 44281, Israel|Novo Nordisk Investigational Site, Nahariya, 22100, Israel|Novo Nordisk Investigational Site, Ofakim, 87520, Israel|Novo Nordisk Investigational Site, Tel Aviv, 6937947, Israel|Novo Nordisk Investigational Site, Tel-Aviv, 62038, Israel|Novo Nordisk Investigational Site, San Juan, 00921, Puerto Rico|Novo Nordisk Investigational Site, Badalona, 08916, Spain|Novo Nordisk Investigational Site, El Ferrol, 15405, Spain|Novo Nordisk Investigational Site, Granada, 18003, Spain|Novo Nordisk Investigational Site, Málaga, 29006, Spain|Novo Nordisk Investigational Site, Sanlúcar de Barrameda, 11540, Spain|Novo Nordisk Investigational Site, Sevilla, 41009, Spain
URL: https://clinicaltrials.gov/show/NCT01907854

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress