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Completed

NCT Number: NCT00263276

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

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

Placebo

Drug

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

metformin

Drug

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

Primary outcomes

  1. Mean change from baseline in HbA1c compared to placebo.

    Time frame: at 12 weeks

Secondary outcomes

  1. 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

    Time frame: at Weeks 6 and 12

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 8, 2005
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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