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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00509236
First Posted: July 31, 2007
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment [ Time Frame: Baseline / Week 54 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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
Actual Study Start Date: October 19, 2007
Study Completion Date: March 14, 2011
Primary Completion Date: March 14, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00509236     History of Changes
Other Study ID Numbers: 0431-073
2007_550 ( Other Identifier: Merck Study Number )
First Submitted: July 27, 2007
First Posted: July 31, 2007
Results First Submitted: February 13, 2012
Results First Posted: May 3, 2012
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


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 Phosphate
Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action