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Clinical Trial Details

Trial ID: L6738
Source ID: NCT01958671
Associated Drug: Ertugliflozin 5 Mg
Title: A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01958671/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Ertugliflozin 5 mg|DRUG: Ertugliflozin 10 mg|DRUG: Placebo to Ertugliflozin|DRUG: Metformin|DRUG: Placebo to Metformin|DRUG: Glimepiride
Outcome Measures: Primary: Change From Baseline In A1C at Week 26, A1C is measured as percent. The change from baseline is the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy., Baseline and Week 26|Percentage of Participants Experiencing An Adverse Event (AE), An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy., Up to 54 weeks (including 2 weeks following last dose)|Percentage of Participants Discontinuing Study Treatment Due to an AE, An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy., Up to 52 weeks | Secondary: Change From Baseline in FPG at Week 26, The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of glycemic rescue therapy., Baseline and Week 26|Change From Baseline in Body Weight at Week 26, The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy., Baseline and Week 26|Percentage of Participants With A1C <7% (<53 mmol/Mol) at Week 26, A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy., Week 26|Baseline 2-hour Post-prandial Glucose (2-hr PPG) Level, Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the Mixed Meal Tolerance Test (MMTT). Change from baseline in 2-hr PPG level at Week 26 data are presented in the following outcome measure., Baseline|Change From Baseline in 2-hr PPG at Week 26, The change from baseline is the Week 26 2-hr PPG minus the Week 0 2-hr PPG. Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the MMTT. Data presented exclude data following the initiation of rescue therapy., Baseline and Week 26|Baseline Sitting Systolic Blood Pressure (SBP), Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in SBP at Week 26 data are presented in the following outcome measure., Baseline|Change From Baseline in SBP at Week 26, The change from baseline is the Week 26 SBP minus the Week 0 SBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy., Baseline and Week 26|Baseline Sitting Diastolic Blood Pressure (DBP), Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in DBP at Week 26 data are presented in the following outcome measure., Baseline|Change From Baseline in DBP at Week 26, The change from baseline is the Week 26 DBP minus the Week 0 DBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy., Baseline and Week 26
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC | Collaborators: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 461
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-10-09
Completion Date: 2016-07-28
Results First Posted: 2017-09-29
Last Update Posted: 2017-09-29
Locations:
URL: https://clinicaltrials.gov/show/NCT01958671