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

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2 End-Stage Kidney Disease	Drug: Sitagliptin Drug: Glipizide	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Dialysis Kidney Failure

Drug Information available for: Glipizide Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment [ Time Frame: Baseline / Week 54 ] [ Designated as safety issue: No ]
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.
Number of Participants With Clinical Adverse Events [ Time Frame: 54 Week Treatment Period + 28 days ] [ Designated as safety issue: Yes ]
Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.

Secondary Outcome Measures:

Number of Participants With Symptomatic Hypoglycemic Adverse Events [ Time Frame: 54 Week Treatment Period + 28 days ] [ Designated as safety issue: Yes ]
A symptomatic hypoglycemic adverse event is an episode with clinical symptoms attributed to hypoglycemia, without regard to fingerstick glucose level.
Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline / Week 54 ] [ Designated as safety issue: No ]
Change from baseline in mean Fasting Plasma Glucose after treatment with sitagliptin versus glipizide for 54 weeks.
Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment [ Time Frame: Baseline / Week 54 ] [ Designated as safety issue: No ]
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.

Enrollment:	129
Study Start Date:	October 2007
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sitagliptin 25 mg	Drug: Sitagliptin 25 mg (one 25-mg tablet) once daily Other Name: MK-0431
Active Comparator: Glipizide 2.5 mg - 20 mg	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 Other Name: Glucotrol

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00509236 History of Changes
Other Study ID Numbers:	MK-0431-073, 2007_550
Study First Received:	July 27, 2007
Results First Received:	February 13, 2012
Last Updated:	April 6, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

Sitagliptin
Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013