Comparing Insulin icodec with Basal insulin analogues for type 2 diabetes mellitus
Official title: A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes
EFFectiveness of Once-weekly Insulin ICodec Versus Once-daily Basal Insulin Analogues in an Insulin-naïve Type 2 diabEtes Population in Real-world cliNical pracTice- The EFFICIENT Pragmatic Study Effectiveness of Insulin Icodec in Real-world Clinical Practice
- Phase 4
- 2 groups
- Sites in Québec, Calgary and 26 more cities
- Recruiting
Interventions
- Medication
Insulin icodec
Insulin icodec will be administered as subcutaneous injection.
- Medication
Basal insulin analogues
Basal insulin analogues will be administered as subcutaneous injection.
Canadian Sites (39)
29 of 39 recruiting
- Recruiting
Centricity Research Calgary Endocrinology
Calgary, Alberta
- Recruiting
Alta Clinical Research at Hermitage Medicentre
Edmonton, Alberta
- Recruiting
Fraser Clinical Trials Inc.
New Westminster, British Columbia
- Recruiting
Winnipeg Clinic
Winnipeg, Manitoba
- Recruiting
G.A. Research Associates Ltd.
Moncton, New Brunswick
- Recruiting
Centricity Research Brampton Endocrinology
Brampton, Ontario
- Recruiting
Centricity Research Vaughn Endocrinology
Concord, Ontario
- Recruiting
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario
- Recruiting
Janik Research
Greater Sudbury, Ontario
- Recruiting
Hamilton Medical Research Group
Hamilton, Ontario
- Recruiting
St. Josephs Health Care
London, Ontario
- Recruiting
Western Univ. Cnt for Studies in Fam Med
London, Ontario
- Recruiting
Centricity Research Ottawa LMC
Nepean, Ontario
- Recruiting
Sewa Ram Singal Medicine Professional Corp
Toronto, Ontario
- Recruiting
Centricity Research Toronto
Toronto, Ontario
- Recruiting
Recherche Clinique Sigma Inc.
Québec
- Recruiting
Diex Recherche Quebec
Québec
- Recruiting
Centre de Recherche Saint-Louis
Québec
- Recruiting
Alpha Recherche Clinique - Lebourgneuf
Québec
- Recruiting
Diex Recherche Joliette
Joliette, Quebec
- Recruiting
Alpha Recherche Clinique - Clinique de Levis
Lévis, Quebec
- Recruiting
Centricity Research Mirabel
Mirabel, Quebec
- Recruiting
Applied Medical Informatics Research
Montreal, Quebec
- Recruiting
Clinique Endocrinologie OASIS.
Montreal, Quebec
- Recruiting
Centricity Res Pointe-Claire
Pointe-Claire, Quebec
- Recruiting
Centre de Recherche Saint-Louis
Sherbrooke, Quebec
- Recruiting
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec
- Recruiting
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec
- Recruiting
Diex Recherche Victoriaville
Victoriaville, Quebec
- Completed
Centricity Clinical Research Burlington
Burlington, Ontario
- Completed
Medical Trust Clinics, Inc.
Courtice, Ontario
- Completed
Malton Medical Clinic
Mississauga, Ontario
- Not yet recruiting
The Ottawa Hospital_Riverside
Ottawa, Ontario
- Completed
Bluewater Clin Res Group Inc
Sarnia, Ontario
- Completed
Centricity Research Toronto Manna Multispec
Toronto, Ontario
- Not yet recruiting
Centre hospitalier de l'Universite de Montreal
Montreal, Quebec
- Not yet recruiting
McGill University Health Centre
Montreal, Quebec
- Completed
ALPHA Recherche Clinique
Québec, Quebec
- Completed
Diex Recherche Sherbrooke
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening:
- +Metformin, Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist.
- +Need of intensification with basal insulin, as indicated at the discretion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- +Recorded HbA1c value ≥7% within the last 90 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
Exclusion
- −Known or suspected hypersensitivity to study intervention(s) or related products.
- −Previous participation in this study. Participation is defined as signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- −Participation (i.e., received any study intervention) in any interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical study within 90 days before screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Any disorder which in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion might jeopardize participant's safety.
- −Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Insulin icodec.
Registry label: A: Insulin icodec
Group B, the comparison group, receives Basal insulin analogues.
Registry label: B: Basal insulin analogues
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 586 people.
The study is currently expected to finish around March 2028.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → week 0 to week 52.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in glycated haemoglobin (HbA1c) — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → week 0 to week 52.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07112339 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Insulin icodecDrug
Insulin icodec will be administered as subcutaneous injection.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Basal insulin analoguesDrug
Basal insulin analogues will be administered as subcutaneous injection.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → week 0 to week 52.
The study as a whole is currently expected to finish around 2028-03-23.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 586 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 29 locations, including: Québec, Canada; Calgary, Alberta, Canada; Edmonton, Alberta, Canada; New Westminster, British Columbia, Canada; Winnipeg, Manitoba, Canada; Moncton, New Brunswick, Canada, and 23 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes. The study will last for about 13 months.
If this study interests you
Three things you can do from here. None of them commits you to anything.
Save it to your Collection
Keep it with the other studies you are looking at.
Share it with your doctor
Send the study to your own clinician to talk through together.
Ask someone to help you approach it
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Or answer a few questions to see which studies in Canada are closest to what you described.
This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.