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

April 7, 2017 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sitagliptin 25 mg
Drug: Sitagliptin
25 mg (one 25-mg tablet) once daily
Other Names:
  • 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 Names:
  • Glucotrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline / Week 54
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.
54 Week Treatment Period + 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
54 Week Treatment Period + 28 days
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.
Baseline / Week 54
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.
Baseline / Week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2007

Primary Completion (Actual)

March 14, 2011

Study Completion (Actual)

March 14, 2011

Study Registration Dates

First Submitted

July 27, 2007

First Submitted That Met QC Criteria

July 27, 2007

First Posted (Estimate)

July 31, 2007

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-073
  • 2007_550 (Other Identifier: Merck Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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