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Clinical Trial Details

Trial ID: L4466
Source ID: NCT01999218
Associated Drug: Ertugliflozin 5 Mg
Title: Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01999218/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Ertugliflozin 5 mg|DRUG: Ertugliflozin 10 mg|DRUG: Glimerpiride|DRUG: Placebo to Ertugliflozin|DRUG: Placebo to Glimepiride|DRUG: Metformin|DRUG: Sitagliptin
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach, A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The primary study objective was the MK-8835 15 mg vs. glimepiride comparison; the MK-8835 5mg vs glimerpiride comparison was a secondary study objective., Baseline and Week 52|Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to Week 106|Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to Week 104 | Secondary: Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 52: Excluding Rescue Approach, Symptomatic hypoglycemia was an event with clinical symptoms reported by the investigator as hypoglycemia (biochemical documentation not required). Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication., Up to Week 52|Change From Baseline in Body Weight at Week 52 Excluding Rescue Approach, This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication., Baseline and Week 52|Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 Excluding Rescue Approach, This change from baseline reflects the Week 52 SBP minus the Week 0 SBP. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication., Baseline and Week 52
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC | Collaborators: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1326
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-12-16
Completion Date: 2017-04-18
Results First Posted: 2018-05-11
Last Update Posted: 2019-04-02
Locations:
URL: https://clinicaltrials.gov/show/NCT01999218