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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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

Key facts

Study ID

NCT00263276

Run by

AstraZeneca

People needed

389

Starts

2005-12-01

Expected to finish

2007-02-01

Last updated by the study team

2016-11-17

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. HbA1c >= 7% and <=10%.
• Patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
• C-peptide > 1.0 ng/ml
• Body Mass Index <= 40 kg/m2
• Serum creatinine < 1.5 mg/dL for men or < 1.4 mg/dL for women.
• No overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g

You may not qualify if…

• Unstable renal disease
• Patients with significant liver disease including chronic active hepatitis
• Within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable CHF,NYHA Class III or IV CHF, TIA, unstable arrhythmia or cardiac revascularization surgery.
• Subjects with clinically significant anemia

Where it is running

• Local Institution — Birmingham, Alabama, United States
• Local Institution — Huntsville, Alabama, United States
• Local Institution — Mobile, Alabama, United States
• Local Institution — Chandler, Arizona, United States
• Local Institution — Tucson, Arizona, United States
• Local Institution — Fayetteville, Arkansas, United States
• Local Institution — Hot Springs, Arkansas, United States
• Local Institution — Beverly Hills, California, United States
• Local Institution — Long Beach, California, United States
• Local Institution — Los Gatos, California, United States
• Local Institution — Mission Viejo, California, United States
• Local Institution — Orange, California, United States
• Local Institution — Redondo Beach, California, United States
• Local Institution — San Diego, California, United States
• Local Institution — Torrance, California, United States
• Local Institution — Colorado Springs, Colorado, United States
• Local Institution — Denver, Colorado, United States
• Local Institution — Boynton Beach, Florida, United States
• Local Institution — Brandon, Florida, United States
• Local Institution — Delray Beach, Florida, United States
• Local Institution — Holly Hill, Florida, United States
• Local Institution — Jacksonville, Florida, United States
• Local Instiuttion — Jacksonville, Florida, United States
• Local Institution — New Port Richey, Florida, United States
• Local Institution — Bayou La Batre, Alabama, United States

Full record on ClinicalTrials.gov

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