Birmingham, AL (PRWEB) April 30, 2013
*Achieve Clinical Research conducts Clinical Studies in Alabama. For more information about participating in this Diabetic Neuropathy Clinical Trial, please visit our website or contact us directly at (205) 380-6434.
Type 2 Diabetes accounts for 90 to 95% of all cases of diabetes and is an increasingly prevalent disease with an estimated 180 million affected people worldwide, and its incidence is expected to double during the next 20 years. Complications induced by hyperglycaemia are currently the most frequent cause of adult-onset loss of vision, renal failure, and amputation in the Industrialized World. Diabetes is also associated with macrovascular complications with a 2- to 4-fold increase in cardiovascular disease risk.
The high frequency of complications leads to a significant reduction of life expectancy. Albumin is an abundant serum protein, which under normal clinical conditions is not detectable in urine. Therefore, increased urinary albumin excretion is an early clinical manifestation of diabetic nephropathy. In addition to being a possible marker of early diabetic nephropathy, albuminuria is also associated with cardiovascular disease in both diabetic and nondiabetic patients.
Moreover, (micro) albuminuria is often present at diagnosis in patients with type 2 diabetes and may reflect both, underlying cardiovascular disease and diabetic nephropathy. Albuminuria is hence an established biomarker that identifies patients with type 2 diabetes at increased risk for vascular complications. Glucose-lowering strategies in these patients aim to reduce the risk for long-term vascular complications of type 2 diabetes.
Although several blood glucose-lowering compounds have been developed to improve glucose control and attenuate the metabolic derangements that accompany uncontrolled type 2 diabetes mellitus, none of these compounds has been able to maintain long-term glycaemic control.
The objective of the current study is to investigate the glycemic efficacy and safety of a new drug given orally once daily for 24 weeks to type 2 diabetes patients with albuminuria (urinary albumin-to-creatinine ratio 30-3000 mg/g creatinine) on top of current standard therapy for diabetic nephropathy (ACEi or ARB).
As a key secondary aim the study will address anti-albuminuric potentials of a new drug in patients at early stages of diabetic nephropathy with micro- or macroalbuminuria.
1. Diagnosis of type 2 diabetes mellitus prior to informed consent.
2. Male and female patients on diet and exercise regimen who are drug-naïve, defined as absence of any oral antidiabetic therapy or already treated by mono or dual oral andiabetic therapy with or without the combination with basal insulin. Diet and exercise regime and antidiabetic therapy (and respective dosing) has to be unchanged for 10 weeks prior to informed consent. The following treatments are allowed as background therapy: Metformin, SU or glinides, alpha-glucosidase inhibitors (AGI), basal insulin. Unchanged therapy prior to informed consent is defined as continuous diet and exercise for treatment naive patients and for patients being drug-treated, no dose change in oral antidiabetic treatments and less than 10% dose change in basal insulin.
3. HbA1c between 7% and 10% at initial visit (screening).
4. Current standard therapy for diabetic nephropathy with either ACEi or ARB (with or without additional background anti-hypertensive therapy). All anti-hypertensive medications at stable dose for 10 weeks prior to informed consent.
5. Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the previous 12 months or detected at Visit 1 (screening). Prior to randomization albuminuria needs to be confirmed by a mean geometric UACR of 30-3000mg/g creatinine at Visit 2. If patients meet UACR criteria at screening, but fail to confirm albuminuria with 3 urine samples at Visit 2 this patient is considered as screening failure.
6. Estimated glomerular filtration rate, eGFR greater than or equal to 30 ml/min, based on the MDRD formula, as determined at Visit 1 (screening)
7. Age 18 to 80 years at Visit 1 (screening).
8. BMI (body mass index) less than or equal to 40 kg/m2 at Visit 1 (screening).
9. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.
*For information about how to participate in a Diabetic Neuropathy Clinical Trial, visit Achieve Clinical Research on the web or contact us directly at (205) 380-6434.