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Completed

NCT Number: NCT00509262

Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.

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Key information

Conditions

Diabetes Mellitus, Type 2 Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases 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

  • Has type 2 diabetes mellitus
  • Has moderate or severe renal insufficiency

Exclusion criteria

  • Has type 1 diabetes mellitus or a history of ketoacidosis
  • Is on a new weight loss program
  • Has active liver disease
  • Is on dialysis or is likely to need dialysis during the study

Treatment and study plan

Sitagliptin

Drug

Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily

Other names: MK-0431, Januvia

Glipizide

Drug

Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)

Other names: Glucotrol

Placebo for Sitagliptin

Drug

Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily

Placebo for Glipizide

Drug

Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54

    Time frame: Baseline to Week 54

    A1C represents percentage of glycosylated hemoglobin.

  2. Percentage of Participants With Hypoglycemic Events

    Time frame: Baseline up to 28 days following the last dose of study therapy

    Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54

    Time frame: Baseline to Week 54

  2. Change From Baseline in Body Weight at Week 54

    Time frame: Baseline to Week 54

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 Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency 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.

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