A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

NCT00263276 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2016-11-17

No results posted yet for this study

Summary

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied

Conditions

Interventions

DRUG

dapagliflozin

Tablets, Oral, 2.5 mg, Once daily, 12 weeks.

DRUG

dapagliflozin

Tablets, Oral, 5 mg, Once daily, 12 weeks.

DRUG

dapagliflozin

Tablets, Oral, 10 mg, Once daily, 12 weeks.

DRUG

dapagliflozin

Tablets, Oral, 20 mg, Once daily, 12 weeks.

DRUG

dapagliflozin

Tablets, Oral, 50 mg, Once daily, 12 weeks.

DRUG

placebo

Tablets, Oral, 0 mg, Once daily, 12 weeks.

DRUG

metformin

Tablets, Oral, \>/= 1500 mg, Once daily, 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Bristol Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • United States
  • Canada
  • Mexico
  • Puerto Rico

Study Locations

More Related Trials

Entities

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 NCT00263276 on ClinicalTrials.gov