Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)

NCT ID: NCT00509236

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-19
• Study Completion Date: 2011-03-14

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.

Conditions

Diabetes Mellitus, Type 2; End-Stage Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sitagliptin 25 mg

Group Type: EXPERIMENTAL

Sitagliptin

Intervention Type: DRUG

25 mg (one 25-mg tablet) once daily

Glipizide 2.5 mg - 20 mg

Group Type: ACTIVE_COMPARATOR

Glipizide

Intervention Type: DRUG

2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg

Interventions

Sitagliptin

25 mg (one 25-mg tablet) once daily

Intervention Type: DRUG

Glipizide

2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg

Intervention Type: DRUG

Other Intervention Names

MK-0431; Glucotrol

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 23352379 (View on PubMed)

Other Identifiers

2007_550

Identifier Type: OTHER

Identifier Source: secondary_id

0431-073

Identifier Type: -

Identifier Source: org_study_id