Phase 3
Completed N=129
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
Source: ClinicalTrials.gov NCT00509236 ↗Enrolled (actual)
129
Serious AEs
34.9%
Results posted
May 2012
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment — 7.89; 7.15; -0.74 Percent hemoglobin A1c — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment |
7.89; 7.15; -0.74 | <0.001 sig |
| PRIMARY Number of Participants With Clinical Adverse Events |
53; 52 | — |
| SECONDARY Number of Participants With Symptomatic Hypoglycemic Adverse Events |
4; 7 | 0.336 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
160.3; 167.0; 135.8; 134.0; -24.5; -33.0 | <0.001 sig |
| SECONDARY Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment |
-0.72; -0.87 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has T2DM.
- Participant is on dialysis on day of signing informed consent.
- Participant is unlikely to conceive or uses acceptable methods of birth control: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
- Participant has hemoglobin A1c ≥7% and ≤9% measured at or within 2 weeks prior to Visit 4/Week -2.
- Participant is ≥85% compliant with study medication during the single-blind placebo run-in (as determined by tablet/capsule count) and compliant with diet, exercise and other run-in treatments during the run-in period.
Exclusion Criteria
- Participant has a history of type 1 diabetes mellitus or a history of ketoacidosis.
- Participant is losing weight in a weight loss program and is not in the maintenance phase (defined as 5 years without documentation of remission/cure.
- Participant is under treatment for hyperthyroidism.
- Participant has a hypersensitivity or contraindication to glipizide.
Data sourced from ClinicalTrials.gov (NCT00509236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.