Avail is conducting a 6-week, Phase 2 randomized study to assess the safety, tolerability and pharmacodynamics of a new combination therapy administered to participants with type 2 diabetes mellitus.
Online PR News – 17-April-2014 – DeLand, Florida – To see if you qualify for this Diabetes Clinical Trial in DeLand, visit Avail Clinical Research on the web (http://www.availclinical.com) or contact us directly at (386) 785-2404. There is no cost to participate, no insurance required, and you may receive compensation for time and travel.
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 with a sodium-glucose co-transporter 2 (SGLT2) inhibitor. SGLT2 inhibition induces negative energy balance by promoting urinary glucose excretion resulting in glucose lowering and weight loss. Stimulation of FaOX under conditions of negative energy balance is hypothesized to be more efficacious than under positive energy balance. Under negative energy balance, it is anticipated that a larger fraction of the acetyl-CoA derived from pharmacological stimulation of β-oxidation will enter into the tri-carbocylic acid cycle for complete oxidation rather than accumulating as partially oxidized intermediates, which have been hypothesized to be potentially detrimental. In order to assess the efficacy of this new form of diabetes therapy under negative energy balance, the impact of the agent will be assessed in combination with the combined inhibitor.
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 that may be conducted with this compound, will be used to determine if further investigation of this compound for the treatment of type 2 diabetes (T2DM) is warranted.
BACKGROUND & RATIONALE
Diabetes mellitus is common in the US and worldwide with approximately 90 to 95% of diabetic patients having T2DM and was once mainly seen in adults over the age of 40 years, but there has been a dramatic rise in its prevalence rates, and it is now increasingly diagnosed in younger people in parallel to rising obesity rates. T2DM is characterized by insulin resistance in muscle and liver, a disorder in which cells do not respond effectively to insulin, resulting in higher blood glucose levels. Elevated blood glucose levels signal the need for more insulin over time and with increasing severity of insulin resistance, hyperinsulinemia eventually leads to insulin deficiency as a result of progressive -cell failure in the pancreas.
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) and macrovascular complications, and are 2 to 4 times more likely to die from cardiovascular disease than adults who do not have diabetes. Several studies have found that by improving glycemic control with pharmacological intervention, the risk of microvascular complications can be significantly reduced. Although these therapies, either singly or in combination, may provide effective glycemic control for some patients, many do not achieve the American Diabetes Association (ADA) target HbA1c (glycosylated hemoglobin) level and glucose control tends to deteriorate over time. Therefore, there is a clear need for new and better therapeutic options that provide effective treatment of T2DM, including therapies that have the potential to increase insulin sensitivity.
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) has been informed of all pertinent aspects of the study.
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. For more information about participating in a Diabetes Clinical Trial, please visit our website or contact us directly at (386) 785-2404.