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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509236
• Other study ID #: 0431-073
• Secondary ID: 2007_550
• Status: Completed
• Phase: Phase 3
• First received: July 27, 2007
• Last updated: March 23, 2015
• Start date: October 2007
• Est. completion date: March 2011

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• End-Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Sitagliptin
25 mg (one 25-mg tablet) once daily
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 Di — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment	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 / Week 54	No
Primary	Number of Participants With Clinical Adverse Events	Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.	54 Week Treatment Period + 28 days	Yes
Secondary	Number of Participants With Symptomatic Hypoglycemic Adverse Events	A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.	54 Week Treatment Period + 28 days	Yes
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG)	Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.	Baseline / Week 54	No
Secondary	Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment	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.	Baseline / Week 54	No