The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who do not have adequate glycemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
129
25 mg (one 25-mg tablet) once daily
2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg
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.
Time frame: 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.
Time frame: 54 Week Treatment Period + 28 days
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline / Week 54
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