At a glance
ClinicalIndex Comparison Record- ✓Age at least 18 years
- ✓Type 2 diabetes mellitus diagnosis
- ✓Chronic renal insufficiency (inadequate kidney function)
- ✕Heart attack, chest pain, or stroke within the past 6 months
- ✕Any condition or therapy deemed not in the patient's best interest by the investigator
- ✕Pregnant or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Sitagliptin Study in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
In Brief
A Phase 3 clinical trial evaluating sitagliptin, Placebo to Sitagliptin, and 2 other interventions for Diabetes Mellitus, Type 2 and Chronic Renal Insufficiency. Completed, enrolled 91 participants.
Detailed Summary
The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).
Study Details
Timeline
Interventions
One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily.
One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily.
One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.
One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.