The present study will assess the effect of a new form of therapy on glycemic and lipidemic parameters when incorporated into an existing diabetes treatment (http://www.availclinical.com/
Over 6 weeks of combined therapy administration, early signs of efficacy are anticipated to be observed in weighted mean daily glucose (WMDG, the primary endpoint); fasting plasma glucose (FPG) and early changes in HbA1c will serve as secondary endpoints. The data of this study in combination with other Phase 2 clinical studies (http://www.availclinical.com/
BACKGROUND & RATIONALE
Diabetes mellitus (http://www.availclinical.com/
Approximately 85% of patients with T2DM are obese or overweight, a key factors underlying the development and maintenance of insulin resistance. Individuals with T2DM have an increased risk of developing both microvascular (nephropathy, neuropathy, retinopathy)
To evaluate the effect on glycemic control (mean glucose) with 200 mg of the new new diabetes drug administered twice-daily over a 6 week study period in adult subjects with T2DM on canagliflozin background therapy.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative)
Subjects who have been diagnosed with T2DM by a medical professional according to the ADA guidelines and are treated with metformin monotherapy at stable doses (greater than or equal to 1000 mg) over the past 3 months and are willing to be switched from treatment with metformin to canagliflozin as background therapy.
While in the study, subjects may continue taking medications prescribed for the treatment of other chronic conditions often associated with diabetes.
Male or female subjects between the ages of 18 and 65 years, both inclusive, at screening.
Male subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A male subject is of childbearing potential if, in the opinion of the investigator, he is biologically capable of having children and is sexually active.
Female subjects must be of non-childbearing potential (NCBP) and must meet at least one of the following criteria:
Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory’s reference range for postmenopausal females;
Have undergone a documented hysterectomy and/or bilateral oophorectomy. Alternatively this may be confirmed by ultrasound;
Have medically confirmed ovarian failure
All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
Body Mass Index (BMI): 25 kg/m2 and a total body weight >50 kg (110 lbs).
HbA1c at screening (with one repeat if necessary): 7.0 and 10.0%.
C-peptide >1.0 ng/mL in fasting state at screening.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Avail Clinical Research conducts a variety of Clinical Research Studies in Florida (http://www.availclinical.com/