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

NCT00509262 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2017-05-12

Study results available
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Summary

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

Conditions

  • Diabetes Mellitus, Type 2
  • Renal Insufficiency, Chronic

Interventions

DRUG

Sitagliptin

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

DRUG

Glipizide

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

DRUG

Placebo for Sitagliptin

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

DRUG

Placebo for Glipizide

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-09
Primary Completion
2011-03-16
Completion
2011-03-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00509262 on ClinicalTrials.gov