Current Research
(For which we are recruiting)
"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"

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Studies for which we are currently recruiting: Click on the research you wish to read about =============================================================

Boehringer Ingelheim 1218.83
Sponsor: Boeringer

Purpose: to assess the efficacy, safety and tolerability of oral linagliptin and metformin compared to linagliptin monotherapy in newly diagnosed, treatment naïve uncontrolled Type 2 Diabetes Mellitus patients

Inclusion criteria:

  1. Newly diagnosed Type 2 Diabetes (less than 12 months prior to . screening) 18 years of age or older
  2. A1c between 8.5% and 12.0%
  3. Treatment naïve of any oral antidiabetic therapy, GLP-1 agonist/analogue or insulin and uncontrolled for 12 weeks prior to randomization
  4. BMI of 45 kg/m or less
Exclusion criteria:
  1. Acute coronary syndrome within 3 months prior to screening
  2. Bariatric , gastric bypass or other gastrointestinal surgeries within the past two years
  3. Medical history of pancreatitis


__________________________________________________________________________________ Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)
Sponsor: Eli Lilly

Purpose: The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.

Inclusion Criteria:
  • Type 2 diabetes on stable doses of up to 2 oral antihyperglycemic agents for at least 3 months
  • Hemoglobin A1c > 6.5% and < 9.5%
  • Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without basal insulin, or basal insulin alone
  • On stable antihyperglycemic regimen for at least 3 months
  • Age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors
Exclusion Criteria
  • History of severe hypoglycemia in past year
  • Acute coronary or cerebrovascular event within past 2 months
  • Planned or anticipated revascularization procedure
  • History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell thyroid disorder


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DM200-103
Sponsor: Conjuchem

Purpose: To evaluate the efficacy and safety of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes on Metformin Monotherapy

Inclusion criteria:

  1. HbA1c > 7.0% and < 11.0%
  2. Body mass index of 27 to 45 kg/m²
  3. Stable daily dose of Metformin > 1000mg
  4. Fasting glucose < 13.3mmol/L
Exclusion criteria:
  1. Use of weight control treatment
  2. Treatment with any other antidiabetic agent other then metformin
  3. Treatment with insulin for longer then 1 week within 3 months prior to screening
  4. History of gastrointestinal intolerance; history of gastroparesis
  5. Heavy tobacco use ( more then ½ pack per day)
__________________________________________________________________________________ Resonate MK=0431E
Sponsor: Merck

Purpose: to assess the glucose-lowering and lipid-modifying efficacy and safety of the combination of sitagliptin and atorvastatin in patients with Type 2 Diabetes who have inadequate glycemic control while on metformin monotherapy.

Inclusion criteria:
  1. Type 2 Diabetes and ≥ 18 and ≤ 79 years of age
  2. A1c ≥ 7.0% ≤ 10%
  3. Monotherapy with Metformin ≥ 1500 mg/day for ≥ 8 weeks
  4. Not on lipid-lowering therapy for at least 6 weeks
Exclusion criteria:
  1. Has ever taken a DPP4 inhibitor or a GLP-1 mimetic
  2. Required insulin therapy in the past 12 weeks
  3. Taken PPARy agonist (TZD) in past 12 weeks
  4. Taken statin or other lipid-lowering agents within 6 weeks (including fish oil, fibrates or niacin > 100mg/day
  5. Currently using psyllium or other fiber-based laxatives or phytosterol margarines, must be on a stable dose regimen for at least 4 weeks prior to screening and remain unchanged.
  6. Consumes > 1.2 litres of grapefruit juice per day
  7. Has a history of hypersensitivity to sitagliptin, atorvastatin, metformin or glimepiride


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TAKEDA SYR-322_402:
Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE)
Sponsor: Takeda Global Research & Development Center, Inc.

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.

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LEADER EX2211-3738
Sponsor: Novo Nordisk

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:
  1. A1c >= 7.0%
  2. >= 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
  3. 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
  • Current malignant neoplasm
__________________________________________________________________________________ ALEGLITAZAR (Ro0728804) BC22140 (ALECARDIO)
Sponsor: Hoffmann-La Roche

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.

Acute Coronary Syndrome (ACS) Definition: Myocardial Infarction (MI) or Unstable Angina

Inclusion Criteria:
Patients must meet ALL of the following criteria in order to be eligible for this study
  • Type 2 Diabetes or newly diagnosed type 2 diabetes ( no earlier then 5 days after the acute phase of the ACS event)
  • Hospitalization for ACS event and randomization 2 to 6 weeks after the event
Exclusion Criteria:
  • Treatment with a thiazolidinedione eg. rosiglitazone (Avandia) or pioglitazone (Actos) and/or fibrate (Lipidil)
  • Prior intolerance to a thiazolidinedione, and/or fibrate
  • Triglycerides (fasting) > 4.5 mmol/L
  • Patients with liver disease or anemia
  • Symptomatic congestive heart failure
  • Hospitalization in the 12 month period preceding the index event for a primary diagnosis of heart failure
  • Peripheral edema which is believed to be clinically severe
  • Participation in any other clinical study with an investigational product or device within one month prior to the screening.

__________________________________________________________________________________ OPT2MISE
Sponsor: Medtronic

Purpose: The purpose of this study is to evaluate the efficacy of insulin pump therapy compared to multiple daily insulin injections in type 2 diabetes mellitus patients who are sub-optimally controlled (A1c between 8% and 12%, inclusive) with multiple daily injections (MDI) of rapid and long acting insulin analogs (basal/bolus therapy).



Inclusion Criteria:
  • Type 2 diabetes mellitus
  • Age 30-75 years old
  • 8.0 % ≤ A1c ≤ 12.0% at screening visit
  • Currently on MDI basal/bolus insulin therapy, defined as ≥ 3 injections per day for at least 3 months prior to screening visit
Exclusion Criteria:
  • subject has a history (≥2 events) of hypoglycemic seizure or hypoglycemic coma within the last 6 months.
  • Subject has a systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg at screening visit
  • Use of a GLP-1 agonist or pramlitide
  • Participation in another clinical trial within 3 months prior to screening visit
  • Subject has renal impairment (eGFR < 30ml/min) at screening
  • Subject is taking medication prescribed for weight loss