| Trial ID: | L1547 |
| Source ID: | NCT00509236
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00509236/results
|
| Conditions: |
Diabetes Mellitus, Type 2|End-Stage Kidney Disease
|
| Interventions: |
DRUG: Sitagliptin|DRUG: Glipizide
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment, Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only., Baseline / Week 54|Number of Participants With Clinical Adverse Events, Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy., 54 Week Treatment Period + 28 days | Secondary: Number of Participants With Symptomatic Hypoglycemic Adverse Events, A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level., 54 Week Treatment Period + 28 days|Change From Baseline in Fasting Plasma Glucose (FPG), Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks., Baseline / Week 54|Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment, Change from baseline in least square means hemoglobin A1c after treatment with sitagliptin versus glipizide for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated., Baseline / Week 54
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
129
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-10-19
|
| Completion Date: |
2011-03-14
|
| Results First Posted: |
2012-05-03
|
| Last Update Posted: |
2017-05-12
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00509236
|
