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Clinical Trial Details

Trial ID: L6855
Source ID: NCT02725593
Associated Drug: Dapagliflozin
Title: Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02725593/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Dapagliflozin|DRUG: Dapagliflozin placebo
Outcome Measures: Primary: Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24, Baseline to Week 24 | Secondary: Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Baseline to Week 24|Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control, Baseline to Week 24|Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24, Baseline to Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Parexel|Q2 Solutions|PRA Health Sciences|Covance
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 72
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-06-22
Completion Date: 2020-04-06
Results First Posted: 2020-12-02
Last Update Posted: 2022-02-23
Locations: Research Site, New Haven, Connecticut, 06514-3434, United States|Research Site, Washington, District of Columbia, 20010, United States|Research Site, Gainesville, Florida, 32610, United States|Research Site, Homestead, Florida, 33032, United States|Research Site, Miami, Florida, 33015, United States|Research Site, Boston, Massachusetts, 02215, United States|Research Site, Bronx, New York, 10467, United States|Research Site, Buffalo, New York, 14222, United States|Research Site, Columbus, Ohio, 43205, United States|Research Site, Philadelphia, Pennsylvania, 19104, United States|Research Site, Greenville, South Carolina, 29615, United States|Research Site, Memphis, Tennessee, 38116, United States|Research Site, Memphis, Tennessee, 38119, United States|Research Site, Lampasas, Texas, 76550, United States|Research Site, McAllen, Texas, 78503, United States|Research Site, Budapest, 1023, Hungary|Research Site, Nyíregyháza, 4400, Hungary|Research Site, Beer Sheva, 84101, Israel|Research Site, Haifa, 91096, Israel|Research Site, Jerusalem, 91120, Israel|Research Site, Ramat Gan, 5265601, Israel|Research Site, Zerifin, 70300, Israel|Research Site, Culiacan, 80230, Mexico|Research Site, Guadalajara, 44670, Mexico|Research Site, Merida, 97134, Mexico|Research Site, Monterrey, 64460, Mexico|Research Site, México, D.F., 11410, Mexico|Research Site, Zapopan, 45116, Mexico|Research Site, Oradea, 410169, Romania|Research Site, Timisoara, 300011, Romania|Research Site, Izhevsk, 426009, Russian Federation|Research Site, Krasnoyarsk, 660022, Russian Federation|Research Site, Moscow, 117036, Russian Federation|Research Site, Novosibirsk, 630087, Russian Federation|Research Site, Pyatigorsk, 357500, Russian Federation|Research Site, Rostov-on-Don, 344022, Russian Federation|Research Site, Samara, 443079, Russian Federation|Research Site, Saratov, 410054, Russian Federation|Research Site, St. Petersburg, 194100, Russian Federation|Research Site, Tomsk, 634050, Russian Federation|Research Site, Kent, CT9 4AN, United Kingdom|Research Site, Leicester, LE15WW, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02725593

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details