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A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

NCT00313313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 768

Last updated 2015-05-04

Study results available
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Summary

The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

Conditions

Interventions

DRUG

Saxagliptin

Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\])

DRUG

Saxagliptin

Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).

DRUG

Glyburide

Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)

DRUG

Placebo

Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)

DRUG

Glyburide

Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)

DRUG

Metformin

Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
77 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-09-30
Completion
2008-09-30

Countries

  • United States
  • Argentina
  • Brazil
  • Hong Kong
  • Israel
  • Mexico
  • Peru
  • Philippines
  • Puerto Rico
  • Singapore
  • South Africa
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00313313 on ClinicalTrials.gov