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Clinical Trial Details

Trial ID: L5488
Source ID: NCT02925559
Associated Drug: Dapagliflozin
Title: Effect of Anti-diabetic Drugs on Glycemic Variability
Acronym: EFFORT
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Dapagliflozin|DRUG: Gliclazide MR
Outcome Measures: Primary: Glycemic Variability, Glycemic Variability defined by the mean amplitude of glycemic excursion (MAGE) measured by CGMS, 12 weeks | Secondary: Glycated hemoglobin A1c (HbA1c) measured as percentage (%), Glycated hemoglobin A1c (HbA1c) measured by HPLC (High Performance Liquid Chromatography), 12 weeks|Fasting plasma glucose (FPG) measured by hexokinase method (mg/dL), Fasting plasma glucose (FPG) measured by hexokinase method after at least 8 hours in fasting state., 12 weeks|Postprandial glucose (PPG) measured by hexokinase method (mg/dL), Postprandial glucose (PPG) measured by hexokinase method 2 hours after lunch, 12 weeks|HbA1c ≤6.5% and <7%, Achievement of HbA1c ≤6.5% and \<7% at the end of the study, 12 weeks|Glycemic variability 2, Glycemic variability defined by the interquartile range (IQR - interval between 25th and 75th percentiles) measured by CGMS, 12 weeks|Glycemic variability 3, Glycemic Variability defined by the Standard Deviation of the mean glycaemia (SD) measured by CGMS, 12 weeks|Glycemic variability 4, Glycemic Variability defined by the Coefficient of Variation (CV) measured by CGMS, 12 weeks|Hypoglycemia, Time spent on hypoglycemic range (glycaemia \<70mg/dL) measured by CGMS, 12 weeks
Sponsor/Collaborators: Sponsor: Centro de Diabetes Curitiba Ltda | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 135
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-10
Completion Date: 2019-01
Results First Posted:
Last Update Posted: 2020-03-04
Locations: Centro de Diabetes Curitiba, Curitiba, Parana, 80810040, Brazil
URL: https://clinicaltrials.gov/show/NCT02925559