30 and older, any sex, with Diabetes Mellitus, Type 2 or End-Stage Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Hemoglobin A1c After Sitagliptin TreatmentPrimary· 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.
Baseline
Group
Value
95% CI
Sitagliptin 25 mg
7.89
± 0.74
Week 54
Group
Value
95% CI
Sitagliptin 25 mg
7.15
± 0.98
Change from Baseline at Week 54
Group
Value
95% CI
Sitagliptin 25 mg
-0.74
± 0.95
Number of Participants With Symptomatic Hypoglycemic Adverse EventsSecondary· 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.
Group
Value
95% CI
Sitagliptin 25 mg
4
Glipizide 2.5 mg - 20 mg
7
Number of Participants With Clinical Adverse EventsPrimary· 54 Week Treatment Period + 28 days
Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.
Group
Value
95% CI
Sitagliptin 25 mg
53
Glipizide 2.5 mg - 20 mg
52
Change From Baseline in Fasting Plasma Glucose (FPG)Secondary· Baseline / Week 54
Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.
Baseline
Group
Value
95% CI
Sitagliptin 25 mg
160.3
± 48.5
Glipizide 2.5 mg - 20 mg
167.0
± 56.2
Week 54
Group
Value
95% CI
Sitagliptin 25 mg
135.8
± 40.4
Glipizide 2.5 mg - 20 mg
134.0
± 58.2
Change from Baseline to Week 54
Group
Value
95% CI
Sitagliptin 25 mg
-24.5
± 47.5
Glipizide 2.5 mg - 20 mg
-33.0
± 55.9
Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide TreatmentSecondary· 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.
Group
Value
95% CI
Sitagliptin 25 mg
-0.72
-0.95 – -0.48
Glipizide 2.5 mg - 20 mg
-0.87
-1.11 – -0.63
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07417618 — INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
· active not recruiting
NCT07390110 — Comparative Effectiveness of Oral Semaglutide vs Sitagliptin Among Individuals With Heart Failure With Preserved Ejectio
· active not recruiting
NCT06851962 — Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
· Phase 4
· active not recruiting
NCT06246799 — Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
· Phase 3
· recruiting
NCT06659718 — Emulation of the SOUL Diabetes Trial in Healthcare Claims
· completed
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
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· Phase 2
· recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part
· recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use
· NA
· recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
· Phase 1
· recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0
· recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
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· Phase 2
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 12 May 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00509236.