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Clinical Trial Details

Trial ID: L4166
Source ID: NCT01617434
Associated Drug: Liraglutide
Title: The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01617434/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: liraglutide|DRUG: placebo
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26, The estimated mean change from baseline in HbA1c after 26 weeks of treatment., Week 0 to Week 26 | Secondary: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26, The estimated mean change from baseline in FPG after 26 weeks of treatment., Week 0 to Week 26|Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26, The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment., Week 0 to Week 26|Change in Body Weight From Baseline to Week 26, The estimated mean change in body weight after 26 weeks of treatment., Week 0 to Week 26|Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target), Number of subjects achieving HbA1c below 7.0% (American Diabetes Association \[ADA\] target) after 26 weeks of treatment, At Week 26|Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target), Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists \[AACE\] target) after 26 weeks of treatment., At Week 26|Number of Adverse Events (AEs) During The Randomised Treatment Period, An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events., Week 0 to Week 26 + 7 days follow up|Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period, A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL)., Week 0 to Week 26 + 7 days follow up|Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period, Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions., Week 0 to Week 26 + 7 days follow up
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 451
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-09
Completion Date: 2013-10
Results First Posted: 2014-10-28
Last Update Posted: 2017-03-08
Locations: Novo Nordisk Investigational Site, Phoenix, Arizona, 85020, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Fresno, California, 93726, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, San Mateo, California, 94401, United States|Novo Nordisk Investigational Site, San Ramon, California, 94583, United States|Novo Nordisk Investigational Site, Tustin, California, 92780-7045, United States|Novo Nordisk Investigational Site, Ventura, California, 93003, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, Gurnee, Illinois, 60031, United States|Novo Nordisk Investigational Site, Greenfield, Indiana, 46140, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Methuen, Massachusetts, 01844, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68114, United States|Novo Nordisk Investigational Site, Newington, New Hampshire, 03801, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27401-1023, United States|Novo Nordisk Investigational Site, McMurray, Pennsylvania, 15317, United States|Novo Nordisk Investigational Site, Spartanburg, South Carolina, 29303, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78215, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78224, United States|Novo Nordisk Investigational Site, Sugarland, Texas, 77478, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84107, United States|Novo Nordisk Investigational Site, Midlothian, Virginia, 23114, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23219, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Martinsburg, West Virginia, 25401, United States|Novo Nordisk Investigational Site, Buenos Aires, C1425AGC, Argentina|Novo Nordisk Investigational Site, Caba, C1179AAB, Argentina|Novo Nordisk Investigational Site, Caba, C1180AAX, Argentina|Novo Nordisk Investigational Site, Córdoba, X5016KEH, Argentina|Novo Nordisk Investigational Site, Coquitlam, British Columbia, V3K 3P4, Canada|Novo Nordisk Investigational Site, Vancouver, British Columbia, V5Z 1M9, Canada|Novo Nordisk Investigational Site, Burlington, Ontario, L7M 4Y1, Canada|Novo Nordisk Investigational Site, Hamilton, Ontario, L8M 1K7, Canada|Novo Nordisk Investigational Site, Hamilton, Ontario, L8N 3Z5, Canada|Novo Nordisk Investigational Site, Mississauga, Ontario, L5M 2V8, Canada|Novo Nordisk Investigational Site, Ottawa, Ontario, K1K 4L2, Canada|Novo Nordisk Investigational Site, Smiths Falls, Ontario, K7A 4W8, Canada|Novo Nordisk Investigational Site, Thunder Bay, Ontario, P7A 4V7, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M3J 1N2, Canada|Novo Nordisk Investigational Site, Westmount, Quebec, H3Z 1E5, Canada|Novo Nordisk Investigational Site, Helsinki, FI-00100, Finland|Novo Nordisk Investigational Site, Kerava, FI-04200, Finland|Novo Nordisk Investigational Site, Tampere, 33520, Finland|Novo Nordisk Investigational Site, Turku, FI-20520, Finland|Novo Nordisk Investigational Site, Ylitornio, FI-95600, Finland|Novo Nordisk Investigational Site, Aschaffenburg, 63739, Germany|Novo Nordisk Investigational Site, Bad Lauterberg, 37431, Germany|Novo Nordisk Investigational Site, Berlin, 10117, Germany|Novo Nordisk Investigational Site, Berlin, 13055, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Gelnhausen, 63571, Germany|Novo Nordisk Investigational Site, Gifhorn, 38518, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Mannheim, 68163, Germany|Novo Nordisk Investigational Site, Mayen, 56727, Germany|Novo Nordisk Investigational Site, Oldenburg, 23758, Germany|Novo Nordisk Investigational Site, Visakhapatnam, Andhra Pradesh, 530002, India|Novo Nordisk Investigational Site, Rohtak, Haryana, 124001, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560034, India|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, 452010, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400012, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302006, India|Novo Nordisk Investigational Site, Kolkatta, West Bengal, 700031, India|Novo Nordisk Investigational Site, Hyderabad, 600034, India|Novo Nordisk Investigational Site, Kolkata, 700017, India|Novo Nordisk Investigational Site, Thriruvananthapuram, 695 032, India|Novo Nordisk Investigational Site, Pachuca, Hidalgo, 42084, Mexico|Novo Nordisk Investigational Site, Mexico, D.F., México, D.F., 03800, Mexico|Novo Nordisk Investigational Site, Almere, 1315 RA, Netherlands|Novo Nordisk Investigational Site, Breda, 4811 SW, Netherlands|Novo Nordisk Investigational Site, Eindhoven, 5616 GB, Netherlands|Novo Nordisk Investigational Site, Groningen, 9728 NT, Netherlands|Novo Nordisk Investigational Site, Hoogeveen, 7909 AA, Netherlands|Novo Nordisk Investigational Site, Leiden, 2333 ZA, Netherlands|Novo Nordisk Investigational Site, Rotterdam, 3021 HC, Netherlands|Novo Nordisk Investigational Site, Velp, 6883 ES, Netherlands|Novo Nordisk Investigational Site, Venlo, 5912 BL, Netherlands|Novo Nordisk Investigational Site, Zoetermeer, 2724 EK, Netherlands|Novo Nordisk Investigational Site, Zwijndrecht, 3331 LZ, Netherlands|Novo Nordisk Investigational Site, Nis, 18000, Serbia
URL: https://clinicaltrials.gov/show/NCT01617434

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress