Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
- Conditions
- -E14 Unspecified diabetes mellitusUnspecified diabetes mellitusE14
- Registration Number
- PER-074-08
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Subjects must be willing and able to give their signed and dated written informed consent.
• Patients must have type 2 diabetes with inadequate glycemic control, defined as an A1C from the central laboratory > 7,0% y < 11,0%.
• Patients must have been receiving stable anti-diabetic treatment. A stable antidiabetic regimen is defined as a therapy consisting solely of diet and exercise, or in combination with a regimen of any approved antidiabetic medication, including insulin, in which doses of oral antidiabetic medications, exenatide or pramiintide, do not have changed during the 6 weeks prior to enrollment; or the doses of long-acting insulin or intermediate-acting insulin have not changed more than 20% during the 6 weeks prior to enrollment.
• Patients with moderate renal impairment. The degree of renal deterioration is defined by the estimated GFR, according to the MDRD study equation, abbreviated reexpressed (four variables). Moderate renal impairment is defined as eTFG between 30 ml / min / 1.73m2 and 53 ml / min / 1.73m2.
• BMI <45.0 kg / m2 at the enrollment visit.
• Men and women, 18 years of age at the time of the enrollment visit.
• Women of childbearing age who are unwilling or unable to use an acceptable method of contraception throughout the entire study.
• Pregnant or lactating women.
• Women with a positive result in the pregnancy test performed at the time of enrollment or before the administration of the investigational product.
• Aspartate Aminotransferase (AST)> 3 x normal upper limit (LSN).
• Alanine Aminotransferase (ALT)> 3 x ULN.
• Total bilirubin (BT)> 2 mg / dl (34.2 umol / l).
• Serum potassium (K)> 5.5 meq / l
• Serum phosphorus (P)> 6.5 mg / dl.
• Serum calcium (Ca) <8 mg / dl or> LSN.
• Positive for hepatitis B surface antigen.
• Positive for antibodies against hepatitis C virus
• Hemoglobin <9.0 g / dl (90 g / l) for men; hemoglobin <8.0 g / dl (80 g / l) for women.
• Creatine kinase (CK)> 3 X LSN.
• Abnormal values of free T4. An abnormal value of thyroid stimulating hormone (TSH) in the enrollment will be subsequently evaluated with free T4. Patients with abnormal free T4 values will be excluded.
• History of diabetes insipidus.
• Symptoms of poorly controlled diabetes that would exclude participation in this trial including, among others, polyuria and polydipsia marked with more than 10% weight loss during the three months prior to enrollment, or other signs and symptoms.
• History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
• Severe non-controlled hypertension defined as SBP> 180 mmHg and / or DBP> 110mmHg.
• myocardial infarction.
• Cardiac or revascularization surgery (GABG / PTCA).
• Unstable angina.
• Unstable congestive heart failure (CHF).
• ICC class III or IV of the New York Heart Association (NYHA).
• Transient ischemic attack (TIA) or significant cerebrovascular disease.
• Unstable or undiagnosed arrhythmia.
• History of unstable or rapidly progressive kidney disease.
• History of lupus nephritis.
• History of renal or systemic vasculitis.
• Antecedents of congenital renal glucosuria.
• History of stenosis of the renal artery, with renovascular hypertension or ischemic nephropathy.
• History of kidney transplant
• Hemodialysis, ultrafiltration therapy or peritoneal dialysis, within 6 months prior to enrollment.
• Significant liver disease, including but not limited to, among others, chronic active hepatitis and / or severe hepatic insufficiency.
• Documented history of hepatotoxicity with any medication.
• History of hemoglobinopathy, with the exception of sickle cell trait (SA) or thalassemia minor; or chronic or recurrent hemolysis.
• Donation of blood or blood products to a blood bank, blood transfusion, or participation in a cylindrical study that required the withdrawal of> 400 ml of blood during the 6 weeks prior to the enrollment visit.
• Malignancy within 5 years of the enrollment visit (with the exception of treated basal cell carcinoma or treated squamous cell carcinoma).
• State of known immunocompromise, including among others, individuals who have undergone organ transplants or who are positive for the human immunodeficiency virus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Measurement of the A1C performed in the central laboratory during the study.<br>Measure:Variation in A1C during the short-term treatment period<br>Timepoints:24 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Measurements of the central laboratory of the GPA throughout the period of short-term treatment.<br>Measure:Variation in fasting plasma glucose levels<br>Timepoints:24 weeks<br>;<br>Outcome name:The total body weight will be measured throughout the study at specified times. Weight measurements should be performed with the patient wearing underwear, without shoes and empty bladder Patients should be weighed with the same scale on all visits.<br>Measure:Variation in total body weight<br>Timepoints:During the study<br>