Diabetes clinic


"The important thing is not to stop questioning. Curiosity has its own reason for existing. One cannot help but be in awe when he contemplates the mysteries of eternity, of life, of the marvelous structure of reality. It is enough if one tries merely to comprehend a little of this mystery every day. Never lose a holy curiosity." ---- Albert Einstein We believe that research is needed to improve Diabetes Care and we have a commitment to participation in clinical research projects to advance knowledge of Diabetes. We have participated in research projects, which we feel offer significant benefits to our patients and advance the cause of effective Diabetes care. Participation in a research project is voluntary and will not adversely affect care standards. All research projects must be reviewed by an independent Ethics Committee to see that the project is worthwhile and does not involve significant risk to a patient’s health. There must be potential benefit to the patient and participants must have full knowledge of all risks and sbenefits. Informed consent must be obtained from the participants. All research studies are carried out in accordance with the “Declaration of Helsinki" ============================================================= Studies for which we are currently recruiting: Click on the research you wish to read about Bayer 17530 Bayer 16244 LPS14245 HARMONY EASE-2 MB 102-230 (DEPICT 2) CREDENCE Spire-1 Spire-2 Cardiovascular Inflammation Reduction Trial (CIRT) ============================================================= BAYER 17530 Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD) Sponsor: Bayer Purpose The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo. Inclusion Criteria Men or women >=18 years of age Subjects with Type Type 2 Diabetes Mellitus as defined by the Canadian Diabetes Association Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent very high albuminuria at the Run-In and Screening Visit Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments Serum potassium <=4.8 mmol/L Exclusion Criteria Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis Uncontrolled arterial hypertension (ie, mean sitting SBP >=170 mmHg or mean sitting DBP >=110 mmHg at run in visit, or mean sitting SBP >=160 mmHg or mean sitting DBP >=100 mmHg at screening) Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms {New York Heart Association (NYHA) class II - IV} at Run in visit [class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)] Dialysis for acute renal failure within 12 weeks of Run-in visit Renal allograft in place or scheduled kidney transplant within next 12 months Glycated hemoglobin (HbA1c) >12%. Back to top ^ ============================================================= BAYER 16244 Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD) Sponsor: Bayer Purpose The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo. Inclusion Criteria Men or women >=18 years of age Subjects with Type 2 diabetes mellitus as defined by the American Diabetes Association Diagnosis of diabetic kidney disease (DKD) with persistent high albuminuria or persistent very high albuminuria at the Run-in and Screening visits: Pretreated with either angiotensin-converting enzyme inhibitor(ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments Serum potassium <=4.8 mmol/L. Exclusion Criteria Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) >=170 mmHg, sitting diastolic blood pressure (DBP) >=110 mmHg at run in visit, or mean sitting SBP >=160 mmHg, sitting DBP >=100 mmHg at screening) Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms New York Heart Association (NYHA class II - IV) at run in visit (class 1A recommendation for mineralcorticoid receptor antagonist (MRAs) Dialysis for acute renal failure within 12 weeks of run in visit Renal allograft in place or scheduled kidney transplant within next 12 months Glycated hemoglobin HbA1c > 12%. Back to top ^ ============================================================= LPS14245 Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies Sponsor: Sanofi Purpose To provide patients with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this patient population.. Inclusion Criteria Either A, B, C, D, or E below and not adequately controlled with a maximally tolerated dose of statin with or without other LMTs, all at stable doses for at least 4 weeks prior to the screening visit (Week -3): A. Patients suffering from heterozygous familial hypercholesterolemia (heFH) with LDL-C concentrations >=.14 mmol/L despite treatment. B. Patients suffering from heFH with LDL- C concentrations >=3.36 mmol/L despite treatment and two or more CV risk factors among this list: LDL-C >6.46 mmol/L at the time of the FH diagnosis (before treatment). Family history of premature-onset coronary heart disease (CHD; first-degree male relative with onset before age 55 years; first-degree female relative with onset before age 65 years). Metabolic syndrome. HDL-C <1.03 mmol/L. Hypertension (blood pressure >140/90 mmHg or drug treatment). Lipoprotein a (Lp[a]) >=1.78 µmol/L. Tendon xanthoma. C. Patients suffering from heFH with LDL-C concentrations >=3.36 mmol/Ldespite treatment and one of the following characteristics: Established CHD or other cardiovascular disease (CVD; history of acute MI, ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, TIA, carotid artery stenosis >=50%, or aortic abdominal aneurysm). Drug-treated type 2 diabetes mellitus or type 1 with target organ damage. Family history of first- or second-degree relative with very premature onset CHD (first- or second-degree male relative with onset before age 45; first- or second-degree female relative with onset before age 55). D. Non-FH patients suffering from established CHD or other CVD (acute MI, ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, TIA, carotid artery stenosis >=50%, or aortic abdominal aneurysm) and with LDL-C >=3.36 mmol/L. E. Patients suffering from progressive CVD (coronary artery disease, or peripheral arterial occlusive disease or cerebrovascular disease as documented clinically or by imaging techniques, with a subsequent CV event [acute MI, ischemic stroke, ischemia-driven revascularization, unstable angina, TIA] despite stable doses of maximally tolerated LLT) with LDL-C >=2.59 mmol/L. Exclusion Criteria Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) and from screening to enrollment. Use of a fibrate other than fenofibrate within 4 wks of the screening visit (Week -3) or between screening and enrollment. Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg (except for patients on simvastatin 80 mg for more than one year, who are eligible). Use of statin other than simvastatin, atorvastatin, or rosuvastatin prior to the screening (Week -3) or between screening and enrollment, except when there is a documented reason for intolerance to the abovementioned potent statins (in which case the use of a different statin is allowed). Fasting serum TG >4.52 mmol/L at the screening visit (Week -3). Uncontrolled HTN (SBP >180 mmHg systolic and/or DBP >110 mmHg at randomization). New York Heart Association Class III or IV congestive heart failure persisting despite treatment. History of hemorrhagic stroke. AST/ALT >3 times the ULN. Laboratory evidence of current hepatitis B or C infection. CK >3 times the ULN. eGFR <30 mL/min/1.73 m^2. Pregnant/ breastfeeding woman or of childbearing potential without appropriate contraception. Pts eligible for an ongoing clinical study of alirocumab conducted at the same investigational site. Hypersensitivity to alirocumab or any of the excipients. Back to top ^ ============================================================= HARMONY Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus Sponsor: GlaxoSmithKline Purpose Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments. Inclusion Criteria Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy. Diagnosis of type 2 diabetes. Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease. HbA1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months). Able and willing to provide informed consent. Exclusion Criteria Severely reduced kidney function: eGFR <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy. Use of a GLP-1 receptor agonist at Screening. Severe gastroparesis History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study. Personal or sfamily history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours. Medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study. Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry. Known allergy to any GLP-1 receptor agonist or excipients of albiglutide. Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device. Any other reason the investigator deems the subject to be unsuitable for the study. Back to top ^ ============================================================= Ease-2 Empagliflozin as Adjunctive to inSulin thErapy in Type 1 Diabetes Over 52 Weeks Sponsor: Boehringer Ingelheim Purpose Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of MDI or CSII. Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.control in patients with type 1 diabetes. Inclusion Criteria Male/ female patient receiving insulin for the treatment of T1DM for greater than one year at the time of Visit 1 Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the central laboratory Use of, and be willing, based on the Investigator's judgement, to continue throughout the duration of the trial, either: MDI of insulin consisting of at least one basal insulin injection and at least three daily bolus injections OR CSII of any insulin type, with at least 5 months experience of using CSII prior to Visit 1 HbA1c >/= 7.5% and /= 18 years at Visit 1 Exclusion Criteria History of T2DM, maturity onset diabetes of the young (MODY), pancreatic surgery or chronic pancreatitis Pancreas, pancreatic islet cells or renal transplant recipient T1DM treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, GLP-1 analogues, SGLT-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to Visit 1 Occurrence of severe hypoglycaemia involving coma and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to Visit 1 Occurence of severe DKA (i.e a pH of <7.0 or prolonged Intensive Care Unit admission exceeding two days) requiring hospitalisation within 3 months prior to Visit 1 Back to top ^ ============================================================= MB 102-230 (DEPICT 2) Efficacy and Safety Study of Dapagliflozin in Type 1 Diabetes Sponsor: Bristol-Myers Squibb (Collaborator: AstraZeneca) Purpose The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes. Inclusion Criteria Diagnosis of Type 1 Diabetes mellitus (T1DM) Central laboratory C-peptide < 0.7 ng/ml Insulin use for at least 12 months per patient reported or medical records Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening Subjects must be on a total insulin dose of > 0.3 U/kg/day for at least 3 months prior to screening If on MDI insulin administration, subject must be on > 3x injections per day Screening Visit: Central laboratory HbA1c >= 7.7% and <= 11.0% Body mass index (BMI) >= 18.5 kg/m2 Exclusion Criteria: History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity Taking any antidiabetic medication (other than insulin), within 1 month prior to screening Taking once weekly GLP-1 receptor agonist, metformin and/or thiazolidinediones within 2 months prior to screening History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening History of Addison's diseasecin, warfarin or anticholinergic drugs. Back to top ^ ============================================================= CREDENCE Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy LLC Sponsor: Janssen Research & Development Purpose The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB). Inclusion Criteria: Type 2 diabetes mellitus with an HbA1c >= 6.5% and <=10.5%, with an estimated glomerular filtration rate (eGFR) of >= 30 and < 90 mL/min/1.73m2 Participants need to be on a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 4 weeks prior to randomization Must have a urine albumin to creatinine ratio (UACR) of > 300 mg/g and <= 5000 mg/g Exclusion Criteria: History of diabetic ketoacidosis or type 1 diabetes mellitus History of hereditary glucose-galactose malabsorption or primary renal glucosuria Renal disease that required treatment with immunosuppressive therapy Known significant liver disease Current or history of New York Heart Association (NYHA) Class IV heart failure Back to top ^ ============================================================= SPIRE-1 The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects Sponsor: Pfizer Purpose This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization, in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 70 mg/dL (1.8 mmol/L) and < 100 mg/dL (2.6 mmol/L) or non-HDL-C >/= 100 mg /dl (2.6 mmol/L) and < 130 mg/dL (3.4 mmol/L). Inclusion Criteria: Must be on background lipid lowering treatment. Must be at high risk of a CV event. /=70 mg/dL (1.8 mmol/L) and < 100 mg/dL (2.6 mmol/L) or non-HDL-C >/= 100 mg/dL (2.6 mmol/L) and < 130 mg/dL (3.4 mmol/L). Exclusion Criteria: An LDL C < 70 mg/dL (1.8 mmol/L) or >/= 100 mg/dL (2.6 mmol/L) or non HDL-C < 100 mg/dL (2.6 mmol/L) or >/=130 mg/dL (3.4 mmol/L). Planned coronary (PCI or CABG) or other arterial revascularization. New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging. Chronic renal insufficiency with creatinine clearance of < 30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis. History of hemorrhagic stroke. Prior exposure to PF-04950615 (RN316) or other investigational PCSK9 inhibitor. Back to top ^ _________________________________________________ SPIRE-2 The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects Sponsor: Pfizer Purpose This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L). Inclusion Criteria: Must be on background lipid lowering treatment. Must be at high risk of a CV event. Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L). Exclusion Criteria: An LDL C < 100 mg/dL (2.6 mmol/L) or non HDL C < 130 mg/dL (3.4 mmol/L). Planned coronary (PCI or CABG) or other arterial revascularization. New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging. Chronic renal insufficiency with creatinine clearance of < 30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis. History of hemorrhagic stroke. Prior exposure to PF 04950615 (RN316) or other investigational PCSK9 inhibitor. Back to top ^ ___________________________________________ Cardiovascular Inflammation Reduction Trial (CIRT) Sponsor: Brigham and Women's Hospital Purpose To determine in a randomized, double blind, placebo-controlled setting weather LDM (low dose methotrexate), given at a target dose of 15-20mg orally weekly will reduce rates of recurrent myocardial infarction, stroke or cardiovascular death among patients with prior history of myocardial infarction and either Type 2 diabetes or metabolic syndrome. Inclusion Criteria Age >= 18 years at screening Myocardial infarction within the past 5 years OR multivessel coronary artery disease by angiography in the past 5 years. History of type 2 diabetes or metabolic syndrome at time of study enrollment Exclusion Criteria Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years; Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed. Men who plan to father children during the study period or who are unwilling to use effective forms of contraception Current indication for methotrexate therapy; Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers Back to top ^