Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: July 31, 2007
Last Update Posted: May 12, 2017
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.
|Diabetes Mellitus, Type 2 End-Stage Kidney Disease||Drug: Sitagliptin Drug: Glipizide||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
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.
|Actual Study Start Date:||October 19, 2007|
|Study Completion Date:||March 14, 2011|
|Primary Completion Date:||March 14, 2011 (Final data collection date for primary outcome measure)|
|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
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