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Clinical Trial Details

Trial ID: L4445
Source ID: NCT02034513
Associated Drug: Insulin Degludec
Title: A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes
Acronym: SWITCH 1
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02034513/results
Conditions: Diabetes|Diabetes Mellitus, Type 1
Interventions: DRUG: insulin degludec|DRUG: insulin glargine|DRUG: insulin aspart
Outcome Measures: Primary: Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period, Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)., A 16-week treatment period. | Secondary: Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period, Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment., After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period, Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration., After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|Incidence of Treatment Emergent Adverse Events, Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment., During 32 weeks of treatment for each treatment period|Change From Baseline in HbA1c (Glycosylated Haemoglobin), Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c absolute value was considered as baseline for calculating change from baseline in HbA1c at week 64., Week 32, Week 64|FPG (Fasting Plasma Glucose), Fasting plasma glucose values at week 32 and week 64., Week 32 and Week 64
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 501
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-01-05
Completion Date: 2016-01-11
Results First Posted: 2017-05-15
Last Update Posted: 2019-01-02
Locations: Novo Nordisk Investigational Site, Birmingham, Alabama, 35215-7502, United States|Novo Nordisk Investigational Site, Goodyear, Arizona, 85395, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Escondido, California, 92025, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, La Jolla, California, 92037, United States|Novo Nordisk Investigational Site, Long Beach, California, 90807, United States|Novo Nordisk Investigational Site, Rancho Cucamonga, California, 91730-3063, 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, Santa Monica, California, 90404, United States|Novo Nordisk Investigational Site, Upland, California, 91786, United States|Novo Nordisk Investigational Site, Ventura, California, 93003, United States|Novo Nordisk Investigational Site, Denver, Colorado, 80220, United States|Novo Nordisk Investigational Site, Cooper City, Florida, 33024, United States|Novo Nordisk Investigational Site, Fleming Island, Florida, 32003, United States|Novo Nordisk Investigational Site, Fort Lauderdale, Florida, 33312, United States|Novo Nordisk Investigational Site, Hialeah, Florida, 33012, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32204, 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, 32256, United States|Novo Nordisk Investigational Site, Miami Springs, Florida, 33166, United States|Novo Nordisk Investigational Site, Miami, Florida, 33130, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, Miami, Florida, 33175, United States|Novo Nordisk Investigational Site, New Port Richey, Florida, 34652, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33026, United States|Novo Nordisk Investigational Site, Port Charlotte, Florida, 33952, United States|Novo Nordisk Investigational Site, Port Orange, Florida, 32127, United States|Novo Nordisk Investigational Site, Lawrenceville, Georgia, 30046, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Arlington Heights, Illinois, 60005-4144, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60611, United States|Novo Nordisk Investigational Site, Crystal Lake, Illinois, 60012, United States|Novo Nordisk Investigational Site, Skokie, Illinois, 60077, United States|Novo Nordisk Investigational Site, Anderson, Indiana, 46011, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46234, United States|Novo Nordisk Investigational Site, Council Bluffs, Iowa, 51501, United States|Novo Nordisk Investigational Site, West Des Moines, Iowa, 50265, United States|Novo Nordisk Investigational Site, Lenexa, Kansas, 66219, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Livonia, Michigan, 48152, United States|Novo Nordisk Investigational Site, Hazelwood, Missouri, 63042, United States|Novo Nordisk Investigational Site, Jefferson City, Missouri, 65109, United States|Novo Nordisk Investigational Site, Kansas City, Missouri, 64106, United States|Novo Nordisk Investigational Site, Billings, Montana, 59101, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68114, United States|Novo Nordisk Investigational Site, Henderson, Nevada, 89052-2649, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89148, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Hamilton, New Jersey, 08690, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Harrison, New York, 10528, United States|Novo Nordisk Investigational Site, Mineola, New York, 11501, United States|Novo Nordisk Investigational Site, Syracuse, New York, 13210, United States|Novo Nordisk Investigational Site, Asheville, North Carolina, 28803, United States|Novo Nordisk Investigational Site, Greenville, North Carolina, 27834, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557, United States|Novo Nordisk Investigational Site, Raleigh, North Carolina, 27609, United States|Novo Nordisk Investigational Site, Toledo, Ohio, 43614, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73104, United States|Novo Nordisk Investigational Site, Jenkintown, Pennsylvania, 19046, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19107, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, 15224-2215, 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, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Austin, Texas, 78758, United States|Novo Nordisk Investigational Site, Carrollton, Texas, 75007, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, El Paso, Texas, 79912, United States|Novo Nordisk Investigational Site, Houston, Texas, 77024, United States|Novo Nordisk Investigational Site, Houston, Texas, 77079, United States|Novo Nordisk Investigational Site, Katy, Texas, 77450, United States|Novo Nordisk Investigational Site, Mesquite, Texas, 75149, United States|Novo Nordisk Investigational Site, Richardson, Texas, 75080, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78229, United States|Novo Nordisk Investigational Site, Schertz, Texas, 78154, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84102, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84107, United States|Novo Nordisk Investigational Site, Chesapeake, Virginia, 23321, United States|Novo Nordisk Investigational Site, Norfolk, Virginia, 23510, United States|Novo Nordisk Investigational Site, Federal Way, Washington, 98003, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Richland, Washington, 99352, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99208, United States|Novo Nordisk Investigational Site, Walla Walla, Washington, 99362-4445, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Bialystok, 15-435, Poland|Novo Nordisk Investigational Site, Gdansk, 80-546, Poland|Novo Nordisk Investigational Site, Gdansk, 80-858, Poland|Novo Nordisk Investigational Site, Szczecin, 70-506, Poland|Novo Nordisk Investigational Site, Warszawa, 04-736, Poland|Novo Nordisk Investigational Site, Zabrze, 41-800, Poland|Novo Nordisk Investigational Site, Manati, 00674, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT02034513

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress