Previous Trials

COMBINE 2
A 52-week study comparing the efficacy and safety of once weekly IcoSema (weekly insulin Icodec combined with weekly semaglutide) and once weekly semaglutide, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with a GLP-1 receptor agonist. The main purpose of the study is to see how well the investigational medicine IcoSema controls blood sugar levels in people with type 2 diabetes. This will be assessed by examining the change in A1c (3 month blood sugar average) throughout the study. Approximately 680 men and women across the world will take part in this study. The information collected during the study may also help us better understand type 2 diabetes or related diseases, how the study medicine works in the body, and how to improve the treatment of people with type 2 diabetes or related diseases.

ARISE study (2019-2025)
The purpose of the ARISE study is to learn about the effects of the study drug in helping to prevent cardiac disease in people with type 2 diabetes. https://clinicaltrials.gov/ct2/show/NCT04083339?term=ARISE&cond=Diabetes&cntry=CA&city=London&draw=2&rank=1

ONWARDS 3 (2021-2022)
This is a 26 week multi-centre, double-blind trial comparing the effect and safety of once weekly insulin icoden and once daily insulin degludec, both in combination with non-insulin anti-diabetic drugs, in naïve subjects with type 2 diabetes. The purpose of the study is to find out how well insulin icodec (an investigational insulin taken once-weekly) controls blood sugar compared to insulin degludec (a once daily insulin already on the market). https://clinicaltrials.gov/ct2/show/NCT04795531?term=ONWARDS+3&draw=2&rank=1

ONWARDS 5 (2022)
This is a 52 week multi-centre trial to investigate the effectiveness and safety of once weekly insulin icodec (an investigational insulin taken once weekly) used with DoseGuide in comparison to once daily basal insulin analogues, both in combination with any non-insulin antidiabetic medication in insulin-naïve subjects with type 2 diabetes mellitus in a clinical practice setting. The purpose of the study is to find out how well insulin icodec used with a DoseGuide App controls blood sugar compared to already marketed daily insulins. https://clinicaltrials.gov/ct2/show/NCT04760626?term=ONWARDS+5&draw=2&rank=1

RESET-IT (2014-2020)
The central problem in type 2 diabetes (T2DM) is an inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. This "beta-cell dysfunction" worsens over time. No current diabetes medications are known to stop this worsening beta-cell dysfunction; therefore, over time patients need permanent insulin therapy. Recent work suggests that early in the course of T2DM, short-term treatment with intensive insulin therapy (IIT) can temporarily improve beta-cell function. RESET-IT aimed to test a new approach. Participants with recently-diagnosed T2DM were treated with a short course of IIT for 3 weeks and then received either (i) intermittent IIT for 2 week every 3 months or (ii) continuous treatment with metformin (the standard first-line medication for the treatment of diabetes). https://clinicaltrials.gov/ct2/show/NCT02192424?term=RESET-IT&draw=2&rank=1

REMIT-IGlarLixi (2017-2020)
This was a multicentre, open-label, randomized controlled trial for patients with recently-diagnosed T2DM. Participants were randomized to 2 treatment groups: (a) a 12-week course of treatment with IGlarLixi (insulin glargine and lixisenatide), metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 68 weeks. In all participants with HbA1C<7.3% at the 12 week visit, glucose-lowering medications were discontinued and participants were encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experienced hyperglycemia relapse after stopping drugs received standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines. https://clinicaltrials.gov/ct2/show/NCT03130426?term=REMIT-IGlarLixi&draw=2&rank=1

Lixilan One CAN (2014-2015)
Compared the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM) (LixilanOne CAN). To demonstrate that the simple daily titration algorithm is non-inferior to the weekly titration algorithm according to Canadian labeling. https://clinicaltrials.gov/ct2/show/NCT02058160?term=LIXILAN+ONE+CAN&draw=2&rank=1

SURE is a prospective study looking at the effectiveness of once-weekly Ozempic (semaglutide) treatment. Participants may experience a difference in their diabetes management and may discover that Ozempic improves their A1c and other outcomes. https://clinicaltrials.gov/ct2/show/NCT03457012?term=NN9535-4428&draw=2&rank=1

CAN-TREAT (2018-2019) is a retrospective data collection study looking at the effectiveness of Tresiba(insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes. https://clinicaltrials.gov/ct2/show/NCT03674866?term=CAN-TREAT&cntry=CA&city=London&draw=2&rank=1

PIONEER 8 (2017-2018)
Type 2 diabetes mellitus (T2DM) is a progressive metabolic disease primarily characterised by abnormal glucose metabolism. The pathogenesis is heterogeneous involving environmental, lifestyle and genetic factors leading to chronic hyperglycaemia caused by peripheral tissue insulin resistance, impaired insulin secretion due to abnormal beta-cell function and abnormal glucose metabolism in the liver. The primary objective of the study is to compare the effect of once-daily dosing of three dose levels of oral semaglutide (3, 7 and 14 mg) versus placebo on glycaemic control in subjects with type 2 diabetes mellitus treated with insulin. The secondary objectives are to compare the effect of once-daily dosing of three dose levels of oral semaglutide (3, 7 and 14 mg) versus placebo on body weight in subjects with type 2 diabetes mellitus treated with insulin; and to compare the safety and tolerability of once-daily dosing of three dose levels of oral semaglutide (3, 7 and 14 mg) versus placebo in subjects with type 2 diabetes mellitus treated with insulin. https://clinicaltrials.gov/ct2/show/NCT03021187?term=PIONEER+8&cntry=CA&city=London&draw=2&rank=1

REMIT DAPA (2015-2018)
The REMIT-Dapa study is a randomized, open-label clinical trial which will evaluate whether an intensive 12-week metabolic intervention using a combination of anti-diabetic medications and lifestyle intervention is more effective in achieving drug-free remission of type-2 diabetes than standard diabetes care. The three anti-diabetic medications which will be used for the 12-week therapy are: Forxiga (dapagliflozin), metformin and insulin glargine. https://clinicaltrials.gov/ct2/show/NCT02561130?term=REMIT+DAPA&cntry=CA&city=London&draw=2&rank=1

DECLARE (Dapagliflozin Effect on CardiovascuLAR Events)(2013-2018)
DECLARE was a 5 year study evaluating whether treatment with dapagliflozin (10 mg once daily) reduces major adverse cardiovascular events in patients with type 2 diabetes (T2DM) and with either known cardiovascular disease or at least two risk factors for cardiovascular disease (e.g., age, hyperlipidemia, hypertension, recent smoking history-primary prevention). The primary objective of the DECLARE Study was to determine whether treatment with dapagliflozin when added to current therapy will result in a reduction in the incidence of cardiovascular death, myocardial infarction (MI), or ischemic stroke. https://clinicaltrials.gov/ct2/show/NCT01730534?term=DECLARE&cntry=CA&city=London&draw=2&rank=1

DUAL IX (2016-2018)
This was a trial to confirm the safety and effectiveness of an investigational drug called insulin degludec/liraglutide (IDegLira), which is a combination of 2 drugs: IDeg and Liraglutide. IDegLira is a blood sugar lowering medication that is being developed for the treatment of type 2 diabetes. The purpose of this trial was to investigate the safety and efficacy of adding IDegLira or insulin glargine (IGlar) to the oral anti-diabetic therapy SGLT2i in subjects with type 2 diabetes who are not able to control their blood sugar levels with their current SGLT2i therapy. It is expected that the blood sugar levels will be improved when adding basal insulin like IDegLira or IGlar to the SGLT2i therapy. This research trial planned to include 416 subjects worldwide. https://clinicaltrials.gov/ct2/show/NCT02773368?term=IDegLira&cntry=CA&city=London&draw=2&rank=2

EASE-3 (2016-2017)
In an extensive Phase III program, empagliflozin (10 mg and 25 mg) was shown to be safe and efficacious in the treatment of patients with T2DM and has received marketing approval in more than 30 countries including the EU and US. Due to its insulin-independent mode of action empagliflozin also has potential for use in the treatment of patients with T1DM. Based on exploratory results from two studies in patients with T1DM (see Section1.2.3.2), this Phase III trial was planned to confirm the efficacy and safety of empagliflozin in patients with T1DM and to further investigate tolerability and PK. The objective of this study was to assess the efficacy, safety, tolerability and PK of once daily oral doses of empagliflozin 2.5 mg, 10 mg and 25 mg compared to placebo in patients with T1DM as adjunctive to insulin therapy. https://clinicaltrials.gov/ct2/show/NCT02580591?term=EASE-3&cntry=CA&city=london&draw=2&rank=1

FIAsp (2013-2015)
The FIAsp Study was a 26-week trial comparing the efficacy and safety of meal time FIAsp with meal time insulin aspart and post meal time FIASP, in combination with insulin detemir in a basal-bolus regimen, followed by a 26-week double-blind extension period for the meal time arms. The objective of the FIAsp project was to develop a faster acting insulin formulation. It was expected that the higher early exposure of FIAsp and faster onset of action would provide further clinical benefits in terms of improved prandial glycaemic control, and increased flexibility of dosing than the currently marketed prandial insulin products. https://clinicaltrials.gov/ct2/show/NCT01831765?term=FIAsp%2C+detemir&cntry=CA&city=London&draw=2&rank=1

LEADER (Liraglutide Effects and Action in Diabetes: Evaluation of Cardiovascular Outcome Results)(2010-2015)
LEADER Study was a 5 year study evaluating the effect of Liraglutide (Victoza) on the incidence of cardiovascular events. People with diabetes are at a high risk for cardiovascular disease and many of these risk factors can be reduced by modern therapies. Liraglutide (Victoza), a GLP-1 analogue, has a favourable effect on these risk factors and hence on cardiovascular events. These factors include hyperglycaemia, insulin resistance, dyslipidemia, hypertension, obesity and increased glucagon. https://clinicaltrials.gov/ct2/show/NCT01179048?term=LEADER&cntry=CA&city=London&draw=2&rank=4

CANOE (Canadian Normoglycemia Outcomes Evaluation)(2004-2010)
CANOE was a double-blind randomized controlled trial was completed in Toronto and London. The study investigated whether low-dose combination therapy would prevent development of type 2 diabetes with three published papers including the major findings published in Lancet. https://clinicaltrials.gov/ct2/show/NCT00116922?term=CANOE&cntry=CA&draw=2&rank=1

REMIT IDegLira (2019-2023)
The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising IDegLira, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission. https://clinicaltrials.gov/ct2/show/NCT03862716?term=REMIT+Ideglira&draw=2&rank=1