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Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

NCT00121641 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1035

Last updated 2015-04-03

Study results available
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Summary

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Saxagliptin

Tablets, Oral, 2.5 mg, Once daily (24 weeks short term \[ST\], 42 months long term \[LT\])

DRUG

Saxagliptin

Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)

DRUG

Saxagliptin

Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)

DRUG

Placebo matching Saxagliptin

Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT)

DRUG

Metformin

Tablets, Oral, 500 mg, daily (42 months LT)

DRUG

Placebo matching Metformin

Tablets, Oral, 0 mg, daily (42 months LT)

DRUG

Saxagliptin

Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label

DRUG

Metformin

Tablets, Oral, 500-2000 mg (as needed for rescue)

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
2005-07-31
Primary Completion
2006-08-31
Completion
2010-02-28

Countries

  • United States
  • Australia
  • Canada
  • Mexico
  • Puerto Rico
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT00121641 on ClinicalTrials.gov