Skip to main content
OpenTrials
Completed

NCT Number: NCT00509236

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Chronic Disease Diabetes Mellitus Disease Attributes End-stage Kidney Disease Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sitagliptin

Drug

25 mg (one 25-mg tablet) once daily

Other names: MK-0431

Glipizide

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

Other names: Glucotrol

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 31, 2007
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.