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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00263276

Enrollment

389

Registered

2005-12-08

Start date

2005-12-31

Completion date

2007-02-28

Last updated

2016-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief 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

Interventions

DRUGdapagliflozin

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

DRUGplacebo

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

DRUGmetformin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in HbA1c compared to placebo.	at 12 weeks

Secondary

Measure	Time frame
Mean change from baseline in fasting plasma glucose, evaluate proportion of subjects who achieve a therapeutic response (HbA1c <7%); change from baseline in urinary glucose excretion	at Weeks 6 and 12

Countries

Canada, Mexico, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026