"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
Purpose: to assess the effect of treatment with liraglutide compared to placebo on first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction (MI) or non-fatal stroke in adults at high risk for cardiovascular events.
Inclusion Criteria:
A1c >= 7.0%
>= 50 years of age with type 2 diabetes and at least one of the below criteria (from a to h)
a) Prior myocardial infarction
b) Prior stroke or transient ischemic attack
c) Prior coronary, carotid or peripheral revascularization
d) >50% stenosis on angiography
e) History of angina with documented ischemia, or unstable angina with ECG changes
f) Asymptomatic angina with positive nuclear imaging test
g) Congestive heart failure (NYHA class II-IV)
h) Chronic renal failure (GFR<60ml/min)
OR
Age >= 60 and evidence of vascular disease defined as at least one of the following (from a to d):
a) Microalbuminuria or proteinuria
b) History/previous treatment of hypertension and left ventricle hypertrophy by ECG or imaging
c) Left ventricular systolic or diastolic dysfunction by imaging
d) Ankle/brachial index <0.9
Patients can be taking oral anti-diabetic medications and/or basal insulin
Exclusion Criteria
Type 1 diabetes mellitus
Use of GLP-1 receptor agonist or pramlintide or any DPP-4 inhibitor 3 months prior to screening
Use of insulin other than basal insulin
An acute coronary or cerebral vascular event within 14 days prior to screening
End stage liver failure or liver transplant
Prior heart transplant or awaiting a heart transplant
Purpose: This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in subjects with type 2 diabetes mellitus and acute coronary syndrome (ACS).
Inclusion criteria:
Type 2 diabetes mellitus
Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization
Subject is receiving monotherapy or combination anti-diabetic therapy with a HbA1c between 6.5% and 11.0%, inclusive, at screening (or between 7.0% and 9.0%, inclusive, if the subject's anti-diabetic regimen includes insulin)
Exclusion criteria:
Subject is hospitalized at Baseline/Randomization Visit.
Subject is receiving a GLP-1 analogue at screening.
Subject has received a DPP-4 inhibitor for either more than 14 days total or within the 3 months prior to screening.
Subject has received dialysis within 14 days prior to screening
Subject has any unstable CV disorder including heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease, and severe hypertension at screening.
Subject has received any investigational drug within 30 days prior to screening or has received an investigational anti-diabetic drug within 3 months prior to Screening.
Purpose: to determine whether treatment with saxagliptin compared to placebo will result in reduction of cardiovascular (CV) death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke.
Inclusion criteria:
>= 40 years of age with type 2 diabetes
A1c between 6.5% and 12% inclusive
Established cardiovascular disease:
-Ischemic heart disease
-Peripheral vascular disease
-Previous myocardial infarction (MI) or ischemic stroke
AND/OR at least one of the following risk factors:
-Dyslipidemia: LDL >3.36mmol/L or HDL <1.04mmol/L for men and <1.30 for women
-Hypertension: BP>140/90 or on BP-lowering agent>130/80
-Currently smoking
Exclusion criteria:
Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 analogues
Acute vascular (cardiac or stroke) event <2months prior to randomization
This study is to evaluate 2 approaches of blood glucose monitoring and insulin titration (patient-managed vs. health care professional) in T2DM patients while receiving the addition of
1 injection insulin glulisine (Apidra) at breakfast following optimization of insulin glargine
(Lantus).
Purpose: This is a cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes. Duration of study is 2.5 years of treatment.
Purpose: This study is designed to evaluate the efficacy and safety of dapagliflozin in lowering blood glucose, body weight and blood pressure compared to placebo and usual care in patients who have type 2 diabetes, cardiovascular disease and hypertension that have inadequate glycemic control.
Inclusion Criteria
Diagnosis of type 2 diabetes
Men > 45 years old; Women > 50 years old
Taking one or two oral anti-diabetic drugs; taking insulin with oral anti-diabetic drugs or taking insulin alone
HbA1c > 7.2% and < 10.5%
Cardiovascular disease defined as: history of myocardial infarction; history of revascularization, coronary artery stenosis > 50 %, prior Stroke or TIA, prior Peripheral Artery Disease treated with revascularization
Hypertension treated with two or more anti-hypertensive drugs or one anti-hypertensive drug with a recorded blood pressure exceeding 130/80
Exclusion Criteria
Diagnoses of type 1 diabetes
Use of 3 or more oral anti-hyperglycemic drugs with or without insulin
Treatment with rosiglitazone (Avandia)
History of diabetic ketoacidosis
Poorly controlled diabetes
FPG > 15.0 mmol/L
Acute coronary syndrome within 2 months; hospitalization for unstable angina or acute myocardial infarction within 2 months; acute stroke or TIA within 2 months; less than 2 months post coronary artery revascularization
Unstable congestive heart failure or acute congestive heart failure
__________________________________________________________________________________
Johnson & Johnson 28431754-DIA-3004
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Purpose: to assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) and to assess the safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus who have reduced kidney function.
Inclusion Criteria:
Patients with type 2 diabetes mellitus
Age >= 25 years
HbA1c between 7.0% and 10.5%, inclusive, at screening and Week-2 visit
Patients with moderate renal impairment
Exclusion Criteria:
Patients with type 1 diabetes
Patients with a history of diabetic ketoacidosis, pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Patients who have proliferative diabetic retinopathy for which treatment is planned during the course of the study
Patients with kidney disease that required treatment with immunosuppressive therapy, history of dialysis or kidney transplant, presence of nephrotic syndrome (ie. severe proteinuria with hypoalbuminemia and/or edema), or inflammatory kidney disease
Patients receiving anti-hypertensive or anti-hyperlipidemic therapy not on a stable regimen
Patients with a history of a severe hypoglycemic episode within 6 months before screening
Purpose: to evaluate the efficacy and safety of two different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus that are receiving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control.
Inclusion Criteria:
Ages 18 to 85
Diagnosis of type 2 diabetes mellitus
Currently treated with PPAR gamma agent (pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin or sulfonylurea)
Exclusion Criteria:
Type 1 diabetes mellitus
History of diabetic ketoacidosis, pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
a severe hypoglycemic episode within 6 months before screening
