Completed Research Studies

 
"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. At the Diabetes Clinic, we have a commitment to participate in clinical research projects that advance knowledge of diabetes. We have participated in many research projects, all of which we feel offer significant benefits to our patients and advancements in the cause of effective diabetes care.


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(DERIVE) D1690C00024 A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
Sponsor: AstraZeneca

The purpose of this study is to evaluate whether oral dapagliflozin (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.


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An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes (MOSAIc)
COMPLETED 2015

The purpose of this study was to identify specific patient, physician, and health system related factors associated with the progression to a more intensive regimen from initial insulin therapy for patients with type 2 diabetes.


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Clinical Usability of Intranasal Glucagon
in Treatment of Hypoglycemia

Sponsor: Locemia Solutions ULC

A Multiple Center, Open Label, Prospective, Observational Study to Evaluate the Effectiveness and Ease-of-Use of AMG504-1 Administered in the Home or Work Environments for Treating Episodes of Hypoglycemia in Patients With Type 1 Diabetes

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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).


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NN2211-3917
Sponsor: Novo Nordisk

Purpose: The effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes


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CV 181-169
Sponsor: Bristol Meyer Squibb

The purpose of this study is to learn if a combination of Saxagliptin and Dapagliflozin added to Metformin can improve Hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.


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TAKEDA SYR-322_402
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).

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ALEGLITAZAR (Ro0728804) BC22140 (ALECARDIO)
Sponsor: Hoffmann-La Roche

Purpose: 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

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SAVOR-TIMI 53
Sponsor: Astra Zeneca

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. 


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DAPA 18 D1690= C00018
Sponsor: AstraZeneca

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.
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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

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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
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CANTATA-MP Trial- Johnson & Johnson 28431754-DIA-3012
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

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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.
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TAKEDA SYR-322_305
Sponsor: Takeda Global Research & Development Center, Inc.

Purpose: To assess the efficacy and safety of alogliptin plus metformin compared to glipizide plus metformin in subjects with type 2 diabetes mellitus whose blood sugar level is inadequately controlled on metformin therapy. The duration of this study will be approximately 2 years.

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LANTU_L_04695 START
Sponsor: Sanofi aventis

Purpose: To evaluate two approaches of blood glucose monitoring and insulin titration (patient-managed vs. health care professional) in type 2 diabetes mellitus patients while receiving the addition of 1 injection of insulin glulisine (Apidra) at breakfast following optimization of insulin glargine (Lantus).

Insulin glargine (Lantus) and insulin glulisine (Apidra) will be provided for the study. Duration of the study is 24 months.

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Johnson & Johnson 28431754-DIA-3004
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Purpose: to assess the effect of canagliflozin relative to placebo in subjects with Type 2 Diabetes with inadequate glycemic control and who have moderate renal impairment.

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DEFEND-1
Sponsor: Tolerx, Inc.

Purpose: to find out if an 8-day series of otelixizumab infusions leads to
greater improvement in insulin secretion as compared with placebo in newly diagnosed type 1 diabetes patients.

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Diabetes Prevention Study (ORIGIN Study)
Sponsor: Sanofi aventis

Purpose: People with IFG, IGT or early diabetes who have evidence of cardiovascular disease have been recruited for this study and are being followed to determine if either insulin glargine-mediated normoglycemia and/or omega- 3 PUFA reduce or prevent incident cardiovascular events. This is a five year study.

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DEFEND-2
Sponsor: Tolerx, Inc.

Purpose: to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo in newly diagnosed type 1 diabetes patients.

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EFC6016-GETGOAL-L
Sponsor: Sanofi aventis

Purpose: A double-blind, randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy and safety of AVE0010 in patients with type 2 diabetes who are insufficiently controlled with basal insulin.

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EFC6017-GETGOAL-P
Sponsor: Sanofi aventis

Purpose: A double-blind, randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy of AVE0010 in addition to pioglitazone in patients with type 2 diabetes who are not adequately controlled with pioglitazone alone.

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NN2211-1842
Sponsor: Novo Nordisk

Purpose: This trial is being conducted in Europe and North America. The aim of this clinical trial is to assess and compare the efficacy of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in people with type 2 diabetes.


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SIBA NN1250-3580
Sponsor: Novo Nordisk

Purpose: A 26-week trial comparing efficacy and safety of long acting insulin NN1250 with sitagliptin (Januvia) in insulin naïve subjects with type 2 diabetes inadequately controlled with 1-2 oral anti-diabetic drugs.


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Apidra_L_04879 (Insulin glulisine)

Purpose: To identify patients’ characteristics associated with achieving target metabolic control in real life settings after 3 months treatment with Apidra in type 1 and 2 diabetes mellitus patients previously uncontrolled on basal insulin +/- other anti-diabetic treatment


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Merck 0431 128-00
Sponsor: Merck & Co.
(results in publication - 2010 -)

Purpose: This study is being conducted to evaluate the safety and efficacy of the addition of sitagliptin (MK-0431) in patients with type 2 diabetes mellitus who have inadequate control on combination therapy with metformin and pioglitazone.


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Boehringer Ingleheim - Linagliptin therapy study
(completed in 2010)

Sponsor: Boehringer Ingleheim Pharmaceuticals

Purpose: The purpose of this study was to evaluate the efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily over 12 weeks as add-on therapy to a twice daily dosing of metformin in patients with type 2 diabetes who have insufficient glycemic control.


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F3Z-EW-S020(c):
Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast

(completed in 2010)

Sponsor: Eli Lilly and Company

Purpose: The purpose of this study was to compare the efficacy and safety of two approaches of starting and intensifying insulin treatment: gradual intensification of insulin lispro low-mixture and insulin lispro mid-mixture treatment with gradual intensification of basal and bolus therapy with insulin glargine and insulin lispro over 48 weeks in the treatment of patient with type 2 diabetes mellitus who consume light breakfast with inadequate glycemic control on oral antihyperglycemic medications.

Results from this study have not yet been published.


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DIVA Study: Diffuse Vascular Disease
(completed in 2010)
Sponsor: Sanofi-Aventis

Purpose: The purpose of this study was to investigate the value of the Edinburgh Claudication Questionnaire (ECQ) against the ankle-brachial index (ABI) in Canadian patients mainly followed in general practice, with documented acute coronary syndrome (ACS)/ischemic stroke (IS)/transient ischemic attack (TIA) and who are not known to have peripheral arterial disease (PAD) at the time of enrollment.

Results from this study are in analysis.


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Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes (SOLVE™)
(completed in 2010)
Sponsor: Novo Nordisk

Purpose: This study was conducted in Europe and North America. The aim of this observational study was to evaluate the safety and efficacy of Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetes patients, over a 24 week period, under normal clinical practice. The objective of diabetes management is to achieve blood glucose levels as close to normal as possible in order to avoid late stage diabetic complications.

Results from this study will be presented at the American Diabetes Association annual meeting in June 2010 and at the Canadian Diabetes Association annual meeting in October, 2010.


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PERFORM Study
(completed in 2009)
PERipheral arterial disease FOR general practice Management A multi-centre clinical Study in subjects with cardiovascular disease risk factors

Sponsor: AstraZeneca

This was a one-visit clinical study in subjects with cardiovascular disease risk factors. No treatment was used in this trial. Lower extremity peripheral arterial disease (PAD) is a prevalent atherosclerotic vascular syndrome, caused by the altered structure and function of the arteries that supply the limbs. The PERFORM Study provided unique data on the prevalence of PAD in a population that had not been diagnosed with PAD.


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ALPHA study
(completed in 2009)
Sponsor: Merck

Purpose: This study was conducted to evaluate the safety and efficacy of sitagliptin 100mg once daily in patients with type 2 diabetes who had inadequate glycemic control on metformin therapy. Results from this study have not yet been published.


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ADAPT
(completed in 2009)
Sponsor: AstraZeneca

Purpose: This study was carried out to evaluate the effect of individualizing starting doses of rosuvastatin according to baseline LDL-cholesterol levels on achieving cholesterol targets in type 2 diabetic patients previously treated with another statin and not at LDL-cholesterol targets.

Results from this study have not yet been published.


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NAVIGATOR Trial
(completed in 2009)
Sponsor: Novartis

This was the largest international diabetes prevention trial that had ever been done. It targeted people over the age of 50 with risk factors of: family history of heart disease, smoking, high blood pressure, lipid (cholesterol) abnormalities, heart disease or stroke. Subjects had impaired glucose tolerance but were not diabetic. The trial used the medications nateglinide (an oral medication which promotes insulin release from the pancreas) and valsartan (a member of a class of medications known as angiotensin receptor blockers). Both drugs were approved and licensed for use in treatment of patients with diabetes and had demonstrated safety and efficacy. The aim of this trial was to see to what extent these drugs could prevent progression to diabetes.

Results: Unfortunately, the results of this study did not indicate a significant reduction in the incidence of diabetes or cardiovascular events among subjects with impaired glucose tolerance who took an angiotensin receptor blocker and short acting insulin secretagogue.


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PREDICTIVE Study
(completed in 2008)
Sponsor: Novo Nordisk

Purpose: The aim of this observational study was to evaluate the incidence of adverse events among insulin dependent patients with type 1 or type 2 diabetes using Levemir under normal clinical practice conditions.

Results: According to European results from this study, Levemir (insulin detemir) improved blood glucose control with a low rate of hypoglycemia and no weight gain following 14 days of treatment.


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The JUPITER Trial
(terminated in 2008)
Sponsor: AstraZeneca

Trial Chairman: Paul M Ridker, MD

The Jupiter trial aimed to answer a critical clinical question: Can statin drugs prevent cardiovascular disease among healthy people with normal low-density lipoprotein (LDL) cholesterol levels but an increased level of high-sensitivity C-reactive protein (hsCRP)?

Rationale: It is known that people with high cholesterol levels are at high risk for heart attacks. However, 50% of people who have heart attacks have normal cholesterol levels. This study examined why individuals with normal cholesterol have cardiovascular events such as heart attacks, angina, and other medical conditions associated with atherosclerosis and arteriosclerosis. The trial was a double-blind, placebo controlled assessment of the use of rosuvastatin in primary prevention of cardiovascular events among “low-risk” individuals. Statin medications were provided for the duration of the study.

hsCRP is a marker of chronic low-level inflammation, a new risk factor for heart attack, stroke, and other cardiovascular events. Unlike those with elevated LDL cholesterol, people with elevated hsCRP levels are generally not aware that they have this condition, and they therefore may not take steps to lower their cardiovascular risk. The Jupiter medical research trial followed approximately 15,000 volunteers at 500 clinics across the United States and Canada. Eligible participants were randomly assigned to receive either rosuvastatin or placebo.

Results: The Jupiter study was terminated early due to very clear evidence of a significant reduction in cardiovascular morbidity and mortality among patients who received rosuvastatin when compared to placebo.


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AVALANCHE
(completed in 2008)
Sponsor: GlaxoSmithKline

Purpose: This study was undertaken to compare combination therapies Avandamet or Avandia + Amaryl to Metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control.


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GSK ADG20001
(completed in 2007)
Sponsor: GlaxoSmithKline

A multicentre, randomized, double-blind, double-dummy, parallel-group placebo-controlled, study to evaluate the efficacy, safety and tolerability of 5 doses of oral GW677954 caps administered once a day as a monotherapy or as add-on-therapy (to subjects on a stable background of Metformin monotherapy) for 16 weeks duration in subjects with type 2 diabetes.

Results: Results from this study indicated that there were no clinically or statistically significant differences in the mean change in A1c from baseline to week 16 for any of the GW677954 doses compared to placebo.


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REACH Registry: A prospective observational study examining subjects at risk of atherothrombotic events
(completed in 2006)
Sponsor: Sanofi-Aventis

Atherothrombosis is the leading cause of death worldwide (WHO, 2001). It is a lifelong disease characterized by a sudden rupture of an atherosclerotic plaque which leads to thrombus formations. A large thrombus, producing a blockage or partial blockage of an artery, often results in stroke or heart attack.

The purpose of this observational study was to collect data on individuals who were considered at risk for an atherothrombotic event in order to evaluate long-term risk of atherothrombosis in daily clinical practice in the overall population at risk and to better define the profile of at risk subjects as well as the predictors of atherothrombotic event. Ankle brachial index (ABI) was used for screening. Results: This observational study found that outpatients with established atherosclerotic arterial disease, or at risk of atherothrombosis, experienced relatively high annual rates of heart attacks or strokes.


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DREAM Trial
(completed in 2006)
Sponsor: Canadian Institute of Health Research

This was a five year international prevention trial conducted by the Canadian Cardiovascular Collaboration and funded by the Canadian Institutes of Health Research. It involved 4000 people at high risk for diabetes; that is, individuals over the age of 30 who did not have diabetes but had impaired glucose tolerance. Participants were given a glucose tolerance test in which they had a sweetened drink and blood glucose levels were tested 2 hrs afterward. Those who had a blood glucose level above the normal level of 7.8 mmol/L but below 11 were considered to have impaired glucose tolerance, which is a risk factor for the development of diabetes. These individuals were eligible to participate in this study using Ramipril (an ACE inhibitor) and/or rosiglitazone (a thiazolidinedione) and/or placebo. The rational was to see to what extent diabetes can be prevented using these drugs. Both of these study drugs were licensed and approved for the treatment of people with diabetes and had an impressive safety record.

Results: This study was completed in 2006. Results indicate that rosiglitazone, when combined with a healthy diet and physical activity, is effective as a diabetes prevention strategy in people at high risk for diabetes.


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Insulin Dry Powder Pulmonary Inhaler (Exubera)
(completed in 2006)
Sponsor: Pfizer

A one year, open-label, outpatient, parallel group trial that assessed the impact of the availability of inhaled insulin (Exubera) on glycemic control in patients with type 2 diabetes mellitus who were poorly controlled on a minimum of two oral anti-diabetic agents. Results: Exubera was found in clinical trials to be as effective as short-acting insulin injections and to significantly improve blood sugar control when added to oral anti-diabetes medications. It was released onto the market in 2006 but was not a commercial success and was therefore discontinued.


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Treatment of Type 2 Diabetes with a Glucagon-Like Peptide
Sponsor: Sanofi-Aventis
Double blind parallel group placebo controlled study of a GLP-1 analogue in the treatment of type 2 diabetes. This was a 12 week, phase 2 study using an injected GLP-1 analogue.

Results: This injectable GLP-1 analogue was found to be effective in the treatment of type 2 diabetes and clinical development continues.


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The POLARIS Study: Lipid Lowering Study using “Statin Drugs” in High Risk Individuals
(completed in 2004)

Sponsor: AstraZeneca

Purpose: This study was done to compare the effects of rosuvastatin treatment with the effects atorvastatin treatment on low density lipoprotein (LDL) cholesterol levels in subjects with high cholesterol and coronary heart disease (CHD) or at a high risk of CHD. Male and female subjects aged 45 to 75 with a history of CHD or clinical evidence of atherosclerosis (diabetic or non-diabetic) or multiple risk factors participated in this study. A total of 871 patients were randomized to either 40mg of rosuvastatin daily or 80mg of atorvastatin daily.

Results: Results from this study indicated that rosuvastatin 40mg daily lowered LDL cholesterol significantly more than atorvastatin 80mg daily. Both treatments were found to significantly raise HDL (“good”) cholesterol and apolipoprotein levels compared to the baseline visit. Both treatments were well tolerated. Based on a US analysis, rosuvastatin used fewer resources and delivered greater efficacy than atorvastatin treatment.


__________________________________________________________________________________ Avandaryl Study
(completed in 2004)
Sponsor: GlaxoSmithKline

Purpose: This was a phase 3 study to investigate the safety & efficacy of a fixed dose combination of rosiglitazone and glimepiride on the treatment of type 2 diabetes.

Results: This study demonstrated the safety & efficacy of this combination drug (Avandaryl) has been approved in Canada for the treatment of type 2 diabetes.



__________________________________________________________________________________ Neuropathy Study
Sponsor: Wyeth

Purpose: This was a double blind, placebo controlled parallel group study of 3 fixed doses of a new treatment in adult outpatients with neuropathic pains associated with diabetic neuropathy.

Results: Unfortunately, results from this study indicated that the study drug did not show sufficient activity in the reduction of neuropathic pain.


__________________________________________________________________________________ Avandamet Study
(completed in 2004)

Sponsor: GlaxoSmithKline

Purpose: A 48 week study comparing the efficacy and tolerability of a fixed-dose combination tablet of rosiglitazone and retformin (Avandamet) to metformin monotherapy in the control of glycemia in type 2 diabetic.

Rationale: Rosiglitazone is an approved treatment in the reduction of glucose levels in type 2 diabetes, and has a direct effect in lowering insulin resistance, which is a fundamental defect in diabetes. Metformin is an approved treatment that reduces glucose levels in type 2 diabetes by decreasing glucose formation by the liver. These therapies are often used in conjunction with one another and have a synergistic effect. The purpose of this study was to establish the safety and efficacy of the use of a Rosiglitazone and Metformin combination tablet in the treatment of diabetes compared to Metformin alone.

Results: The study is complete and has demonstrated the safety and efficacy of this combination drug. Avandamet is now approved for the treatment of type 2 diabetes in Canada.


__________________________________________________________________________________ Glargine (INSIGHT) Study
(completed in 2003)
Sponsor: McMaster University & Sanofi-Aventis

Purpose: The purpose of this study was to compare the efficacy of early addition of insulin glargine to insulin avoidance in people with type 2 diabetes on either no glucose lowering agents or submaximal doses of metformin and/or sulfonylurea.

Results: Data from this study suggest that in type 2 diabetes patients who are either drug naïve or who are taking one or less than maximal doses of two oral glucose lowering agents, the early introduction of insulin glargine is more likely to achieve glucose control than a conventional therapeutic strategy in which physicians avoid adding insulin by increasing or adding oral agents.


__________________________________________________________________________________ Pioglitazone Study
(completed in 2003)
Sponsor: Canadian Centre for Research on Diabetes

This was an observational study that demonstrated the safety and efficacy of pioglitazone in the treatment of insulin resistant patients with type 2 diabetes. The study showed that the glucose controlling effect of pioglitazone is equivalent to that of roziglitazone. This was a study funded entirely by the Diabetes Clinic, without outside help, and enrolled patients from Smiths Falls and Hawkesbury, ON.

Results from the first 18 months of the trial were presented at the Canadian Diabetes Association annual meeting in Oct 2002 in Vancouver and are published in the Canadian Journal of Diabetes Care, Sept 2002, Vol. 26, Pg 308. This study demonstrated the value of pioglitazone in type 2 diabetes, as most patients achieved optimal glucose control and increased insulin sensitivity. Improvements in lipid levels were also observed.



__________________________________________________________________________________ 2003 CANADIAN DIABETES ASSOC CLINICAL PRACTICE GUIDELINES: Are they Attainable in Practice?
(completed in 2006)
Sponsor: Canadian Centre for Research on Diabetes

This study ran for 1 year, from Oct 2002-Oct 2003. The draft of the proposed 2003 Clinical Practice Guidelines for the treatment of diabetes had been presented at the Oct 2002 Annual Meeting of the CDA in Vancouver B.C. This study intended to see if these guidelines were attainable in practice. 3000 patients with diabetes were treated with the new guidelines as target values; A1c <7%, pre-prandial glucose <7, post prandial glucose <11, TC/HDL <4, LDL <2.5, Trig <1.7, ACR <2 (men), <2.5 (women), BP <130/80. On average all new targets were achieved, except triglyceride targets, where the average triglyceride level was 1.88. 80% of patients were on an ACE inhibitor and 70% on ASA.

Conclusion: 2003 CDA-CPG guideline targets are achievable in the majority of patients with no increase in number of physician visits or laboratory costs, but with an increase in the number of drugs from 7.2 meds/patient to reach the 1998 guidelines to 8.4 meds/patient to reach the 2003 guidelines. This study was presented at the CDA meeting in Ottawa in Oct 2003 and the abstract published in The Canadian Journal of Diabetes Sept 2003, Vol. 27, No 3, Abstract 215 page 353.


__________________________________________________________________________________ Insulin Pump Study
(completed in 2002)
Sponsor: Canadian Centre for Research on Diabetes

This study, entitled Option or Essential Tool? Insulin Pump Therapy in Young Women, was carried out in our Trenton Clinic and Smiths Falls Clinic in association with Jill Milliken R.N., C.D.E. This study demonstrated the benefits of insulin pump therapy for the unique problems of young women with type 1 diabetes. This study was published in the June 2002 issue of DIABETES and was presented at the American Diabetes Association annual meeting in San Francisco in June 2002.


__________________________________________________________________________________ Aldose Reductase Study
Purpose: This phase 2 study was conducted to evaluate the safety and efficacy of an aldose reductase inhibitor as potential therapy for the treatment of type 2 diabetes. The drug appeared to be effective for the treatment of diabetes but had unacceptable side effects and was therefore not approved.


__________________________________________________________________________________ Community Based Insulin Pump Outcomes
(completed in 2002)
Sponsor: Canadian Centre for Research on Diabetes

This review of 100 patients on insulin pumps, started in rural communities, showed HgbA1c Values that fell from a pre-pump level of 9.4% to 7.2% on insulin pump therapy. The study, done in association with Jill Milliken R.N., C.D.E., demonstrated that insulin pump therapy can be implemented effectively in a community based setting and achieve significant positive outcomes. This study was presented at the Canadian Diabetes Association meeting in Vancouver B.C. in Oct 2002 and is published as an abstract in the Canadian Journal of Diabetes, Sept 2002, Vol. 26, Pg 272.


__________________________________________________________________________________ Telmisartan Study
(completed in 2001)
Sponsor: Boehringer Ingleheim

This study was an international study on the efficacy and safety of telmisartan, a member of the angiotensin receptor blocker (ARB) class of drugs.

Results: The results of this study demonstrated the safety and efficacy of this medication in the treatment of high blood pressure. Telmisartan has been approved for use in Canada.


__________________________________________________________________________________ Effectiveness of Rosiglitazone in Clinical Practice Study
Sponsor: Dalhousie University and GlaxoSmithKline

This study was done in cooperation with Dr. Ehud Ur & his group from Dalhousie university in Halifax. It was a multicenter study involving 1500 patients in 9 centres across Canada. The study demonstrated that, in a group of patients in a typical diabetes care situation with an average A1c of 8.81% at baseline, the addition of rosiglitazone resulted in an A1c reduction to an average of 8.27% in the first 12 weeks of treatment, with continued lowering to 7.86% at 24 weeks. The improved glycemic control persisted for more than a year with an average A1c of 7.81% after 52 weeks. 30% of patients achieved CDA target levels for optimal glucose control of A1c <7%. Those patients who continued on rosiglitazone had continued improvement with average A1c lower than baseline at 7.86%. There were no significant changes in lipid values but there was a 5 mm improvement in systolic blood pressure. Congestive cardiac failure was reported in 9 patients and elevated liver enzymes were seen in less that 1% of lab visits. Only 7% of patients discontinued the drug although 30% reported fluid retention or weight gain.

Results: Rosiglitazone was found to be effective in Clinical Practice in Canada providing significant long term improvement in glycemic control. It is being used effectively as a first, second and third line therapy with few reported side effects.

This study was presented at the International Diabetes Federation Meeting in Paris, Aug 2003 and the abstract published in Diabetes & Metabolism Aug 2003, page 4S246.


__________________________________________________________________________________ Rosiglitazone in Clinical Practice in Canada Study
(completed in 2001)
Sponsor: Canadian Centre for Research on Diabetes

This was a study of patients with type 2 diabetes who had not achieved control of diabetes despite maximal doses of conventional medications. With the introduction of the newly approved drug of the thiazolidinedione class of insulin sensitizer, most patients were able to achieve optimal glucose goals. This study was entirely funded by the Diabetes Clinic without outside assistance. The results were published in the June 2001 issue of DIABETES (supplement). The patients involved were from our clinics in Smiths Falls, ON and Hawkesbury, ON. Results were presented at the 2001 meeting of the American Diabetes Association and at the Oct 2001 annual meeting of the Canadian Diabetes Association. Updated results giving data from Feb 2000 to Aug 2002 were presented at the Canadian Diabetes Association Annual Meeting in Vancouver 2002 and was published as an abstract in the Canadian Journal of Diabetes Sept 2002, Vol. 26, Pg 308. Updated results to July 2003 were presented in Paris in Aug 2003 at the International Diabetes Federation Meeting and are published in Diabetes & Metabolism Aug 2003 Page 4S246 Abstract 2272, Practical Application of Rosiglitazone in Clinical Practice. There is also a copy of the poster available on this web site in Presentations. This study was significant in that it demonstrated the potential of this new class of drug for type 2 patients who had run out of treatment options and were facing insulin treatment. Most patients achieved optimal glucose control levels. 5% of patients experienced side effects.


__________________________________________________________________________________ DIASCAN (Diabetes Screening in Canada) Study
(completed in 1999)
Sponsor: Servier Canada

Purpose: This was a study carried out across Canada in family practitioners’ offices. It involved glucose testing in the office and demonstrated that 16% of Canadians over the age of 40 presenting in a physicians office have diabetes, and that half of those with diabetes are undiagnosed. The study showed that the burden of disease in patients with diabetes is far higher than the incidence of the disease.

Results: The screening process yielded a clinically significant number of new cases of patients with diabetes and glucose intolerance. The data supported the CDA and ADA recommendations to screen high-risk individuals. Results from this study were published in Diabetes Care June 2001 vol. 24 no. 6 1038-1043.