Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2; End-Stage Kidney Disease
Intervention: Sitagliptin (Drug); Glipizide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Hemoglobin A1c After Sitagliptin TreatmentNumber of Participants With Clinical Adverse Events
Secondary outcome: Number of Participants With Symptomatic Hypoglycemic Adverse EventsChange From Baseline in Fasting Plasma Glucose (FPG) Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: October 2007
Last updated: March 23, 2015
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