Clinical trial NCT00509236: Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
End-Stage Kidney Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-07-31
Enrollment: 129
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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 \<2 kg weight loss in 2 months), or intends to be involved in weight loss intervention outside that prescribed by the study.
* Participant has a clinically significant hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
* Participant has cirrhosis or active liver disease.
* Participant has been on dialysis for \< 6 months.
* Participant has been diagnosed with a significant cardiovascular disorder and has new or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent.
* Participant has severe active peripheral vascular disease.
* Participant has a history of malignancy ≤ 5 years prior to signing informed consent, or \> 5 years without documentation of remission/cure.
* Participant is under treatment for hyperthyroidism.
* Participant has a hypersensitivity or contraindication to glipizide.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment
timeFrame: Baseline / Week 54
measure: Number of Participants With Clinical Adverse Events
timeFrame: 54 Week Treatment Period + 28 days
Secondary outcomes:
measure: Number of Participants With Symptomatic Hypoglycemic Adverse Events
timeFrame: 54 Week Treatment Period + 28 days
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Baseline / Week 54
measure: Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment
timeFrame: Baseline / Week 54
Other outcomes:
Locations:
Study officials:
References:
citation: Arjona Ferreira JC, Corry D, Mogensen CE, Sloan L, Xu L, Golm GT, Gonzalez EJ, Davies MJ, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial. Am J Kidney Dis. 2013 Apr;61(4):579-87. doi: 10.1053/j.ajkd.2012.11.043. Epub 2013 Jan 24.