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Clinical Trial Details

Trial ID: L1937
Source ID: NCT03687827
Associated Drug: Insulin Degludec
Title: A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study
Acronym: SWITCH PRO
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03687827/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin degludec|DRUG: Insulin glargine
Outcome Measures: Primary: Percentage of Time Spent in Glycaemic Target Range 70-180 mg/dL (3.9-10.0 mmol/L) Both Inclusive, Using Flash Glucose Monitoring (FGM), The percentage of time spent in glycaemic target range was calculated as the number of recorded measurements in glycaemic target range (70-180 milligrams per deciliter \[mg/dL\] (3.9-10.0 millimoles per litre \[mmol/L\]), both inclusive) divided by the total number of recorded measurements. The endpoint is based on data recorded by FGM system. It was required that at least 70% of the planned FGM measurements during weeks 16-17 and weeks 34-35 were available for endpoint data to be included in the analysis., During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2) | Secondary: Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring, The percentage of time spent in tight glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, during the 2-week maintenance periods using FGM (visit 9-21 (week 16-17) and visit 37-39 (week 34-35))., During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).|Time Spent in Nocturnal Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, in the Nocturnal Period (00:01 am - 05:59 am Both Inclusive) Using Flash Glucose Monitoring, Percentage of time spent in nocturnal glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, in the nocturnal period (00:01 am - 05:59 am both inclusive) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35))., During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).|Level of Glycated Haemoglobin (HbA1c) - Percentage, Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35))., After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).|Level of Glycated Haemoglobin (HbA1c) - mmol/Mol, Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35))., After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).|Mean Glucose Levels Using Flash Glucose Monitoring (FGM), Mean glucose levels (mmol/L) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35))., During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 498
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-10-02
Completion Date: 2019-12-27
Results First Posted: 2021-01-12
Last Update Posted: 2021-01-12
Locations: Novo Nordisk Investigational Site, Chandler, Arizona, 85224, United States|Novo Nordisk Investigational Site, Tucson, Arizona, 85741, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Lancaster, California, 93534, United States|Novo Nordisk Investigational Site, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, Poway, California, 92064, United States|Novo Nordisk Investigational Site, Van Nuys, California, 91405, United States|Novo Nordisk Investigational Site, Hamden, Connecticut, 06517, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Cooper City, Florida, 33024, United States|Novo Nordisk Investigational Site, Hollywood, Florida, 33024, United States|Novo Nordisk Investigational Site, New Port Richey, Florida, 34652, United States|Novo Nordisk Investigational Site, Orlando, Florida, 32825, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33027, United States|Novo Nordisk Investigational Site, Skokie, Illinois, 60077, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Louisville, Kentucky, 40213, United States|Novo Nordisk Investigational Site, Boston, Massachusetts, 02115-5804, United States|Novo Nordisk Investigational Site, Boston, Massachusetts, 02118, United States|Novo Nordisk Investigational Site, Kalispell, Montana, 59901, United States|Novo Nordisk Investigational Site, New Windsor, New York, 12553, United States|Novo Nordisk Investigational Site, Greenville, North Carolina, 27834, United States|Novo Nordisk Investigational Site, Statesville, North Carolina, 28625, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45245, United States|Novo Nordisk Investigational Site, Toledo, Ohio, 43614, United States|Novo Nordisk Investigational Site, Pelzer, South Carolina, 29669, United States|Novo Nordisk Investigational Site, Dakota Dunes, South Dakota, 57049, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37203, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Kerrville, Texas, 78028, 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, San Antonio, Texas, 78228-6205, United States|Novo Nordisk Investigational Site, Calgary, Alberta, T2H 2G4, Canada|Novo Nordisk Investigational Site, Victoria, British Columbia, V8V 4A1, Canada|Novo Nordisk Investigational Site, Concord, Ontario, L4K 4M2, Canada|Novo Nordisk Investigational Site, Etobicoke, Ontario, M9R 4E1, Canada|Novo Nordisk Investigational Site, London, Ontario, N5W 6A2, Canada|Novo Nordisk Investigational Site, Markham, Ontario, L3P 7P2, Canada|Novo Nordisk Investigational Site, Oakville, Ontario, L6M 1M1, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M4G 3E8, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M6G 1M2, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, H4A 2C6, Canada|Novo Nordisk Investigational Site, Bialystok, 15-351, Poland|Novo Nordisk Investigational Site, Bialystok, 15-404, Poland|Novo Nordisk Investigational Site, Gdansk, 80-858, Poland|Novo Nordisk Investigational Site, Lublin, 20-538, Poland|Novo Nordisk Investigational Site, Warsaw, 00-465, Poland|Novo Nordisk Investigational Site, Ponce, 00716, Puerto Rico|Novo Nordisk Investigational Site, Bratislava, 831 01, Slovakia|Novo Nordisk Investigational Site, Bratislava, 851 01, Slovakia|Novo Nordisk Investigational Site, Bytca, 014 01, Slovakia|Novo Nordisk Investigational Site, Levice, 93401, Slovakia|Novo Nordisk Investigational Site, Malacky, 901 01, Slovakia|Novo Nordisk Investigational Site, Nove Mesto nad Vahom, 915 01, Slovakia|Novo Nordisk Investigational Site, Nove Zamky, 940 59, Slovakia|Novo Nordisk Investigational Site, Trebisov, 07501, Slovakia|Novo Nordisk Investigational Site, Trnava, 91701, Slovakia|Novo Nordisk Investigational Site, Zilina, 010 01, Slovakia|Novo Nordisk Investigational Site, Port Elizabeth, Eastern Cape, 6045, South Africa|Novo Nordisk Investigational Site, Bloemfontein, Free State, 9301, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1827, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1829, South Africa|Novo Nordisk Investigational Site, Lenasia, Gauteng, 1827, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0044, South Africa|Novo Nordisk Investigational Site, Cape Town, Western Cape, 7130, South Africa
URL: https://clinicaltrials.gov/show/NCT03687827

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress