| Trial ID: | L2050 |
| Source ID: | NCT03267576
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| Associated Drug: |
Canagliflozin 300 Mg
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| Title: |
An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
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| Acronym: |
COMETA
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT03267576/results
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Canagliflozin 300 mg|DRUG: Sitagliptin 100 mg|DRUG: Metformin
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| Outcome Measures: |
Primary: Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1, Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27)|Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2, Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 2 (Days 66 to 71) | Secondary: Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile, Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Change From Baseline in Mean 24-hour Glucose Profile, Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Change From Baseline in Fasting Plasma Glucose Levels, Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels, 2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL, Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL, Percent change from baseline in time during 24 hours within the glucose levels \>140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL, Percent change from baseline in time during 24 hours within the glucose levels \>180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL, Percent change from baseline in time during 24 hours within the glucose levels \< 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL, Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Change From Baseline in Time Spent With Glucose Level > 140 mg/dL, Time spent with the glucose level \> 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Change From Baseline in Time Spent With Glucose Level > 180 mg/dL, Time spent with the glucose level \> 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Change From Baseline in Time Spent With Glucose Level < 70 mg/dL, Time spent with the glucose level \< 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL, The percentage of 2 consecutive glucose readings with \< 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure., Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
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| Sponsor/Collaborators: |
Sponsor: Janssen Research & Development, LLC
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| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
PHASE4
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| Enrollment: |
64
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2017-10-27
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| Completion Date: |
2018-10-01
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| Results First Posted: |
2019-11-29
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| Last Update Posted: |
2019-11-29
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| Locations: |
Consultorio Privado, Guadalajara, 44150, Mexico|Investigación Clínica Especializada, Guadalajara, 44600, Mexico|Consultorio Privado en Unidad de Patología Clínica, Guadalajara, 44650, Mexico|Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán, Mexico City, 14080, Mexico|Hospital Universitario 'Dr. Jose Eleuterio Gonzalez', Monterrey, 64460, Mexico
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| URL: |
https://clinicaltrials.gov/show/NCT03267576
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