Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
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|ClinicalTrials.gov Identifier: NCT00509236|
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : May 3, 2012
Last Update Posted : May 12, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 End-Stage Kidney Disease||Drug: Sitagliptin Drug: Glipizide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control|
|Actual Study Start Date :||October 19, 2007|
|Actual Primary Completion Date :||March 14, 2011|
|Actual Study Completion Date :||March 14, 2011|
|Experimental: Sitagliptin 25 mg||
25 mg (one 25-mg tablet) once daily
Other Name: MK-0431
|Active Comparator: Glipizide 2.5 mg - 20 mg||
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
Other Name: Glucotrol
Primary Outcome Measures :
- Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment [ Time Frame: Baseline / Week 54 ]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.
- Number of Participants With Clinical Adverse Events [ Time Frame: 54 Week Treatment Period + 28 days ]Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.
Secondary Outcome Measures :
- Number of Participants With Symptomatic Hypoglycemic Adverse Events [ Time Frame: 54 Week Treatment Period + 28 days ]A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.
- Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline / Week 54 ]Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.
- Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment [ Time Frame: Baseline / Week 54 ]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.
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