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Diabetes Mellitus, Type 2Phase 4NCT07112339

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

A Phase 4 study testing Insulin icodec and Basal insulin analogues in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 75 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin icodec and Basal insulin analogues
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
586 participants
Where
75 sitesin 3 countries
Study dates
15 Aug 2025to 23 Mar 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening.
  • 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 investigator.
  • Recorded HbA1c value ≥7% within the last 90 days prior to randomization.

Who cannot join

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Previous participation in this study. Participation is defined as signed informed consent.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.
  • Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening.
  • Any disorder which in the investigator's opinion might jeopardize participant's safety.

Trial locations and contacts

75 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

75 sites in 3 countries

Canada39 sites, 32 recruiting

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

    Recruiting

  • Centricity Clinical Research Burlington

    Burlington, Ontario, L7M 4Y1

    Completed

  • Centricity Research Calgary Endocrinology

    Calgary, Alberta, T2H 2G4

    Recruiting

  • Centricity Research Vaughn Endocrinology

    Concord, Ontario, L4K 4M2

    Recruiting

  • Medical Trust Clinics, Inc.

    Courtice, Ontario, L1E2J5

    Completed

  • Alta Clinical Research at Hermitage Medicentre

    Edmonton, Alberta, T5A 4L8

    Recruiting

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

    Recruiting

  • Janik Research

    Greater Sudbury, Ontario, P3C 1SB

    Recruiting

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8M 1K7

    Recruiting

  • Diex Recherche Joliette

    Joliette, Quebec, J6E 6A9

    Recruiting

  • Alpha Recherche Clinique - Clinique de Levis

    Lévis, Quebec, G6V 0C9

    Recruiting

  • St. Josephs Health Care

    London, Ontario, N6A 4V2

    Recruiting

  • Western Univ. Cnt for Studies in Fam Med

    London, Ontario, N6G 2M1

    Recruiting

  • Centricity Research Mirabel

    Mirabel, Quebec, J7J 2K8

    Recruiting

  • Malton Medical Clinic

    Mississauga, Ontario, L4V 1P1

    Completed

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

    Recruiting

  • Centre hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2W 1R7

    Not yet recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

    Not yet recruiting

  • Applied Medical Informatics Research

    Montreal, Quebec, H4A 3T2

    Recruiting

  • Clinique Endocrinologie OASIS.

    Montreal, Quebec, H4J 1E3

    Recruiting

  • Centricity Research Ottawa LMC

    Nepean, Ontario, K2J 0V2

    Recruiting

  • Fraser Clinical Trials Inc.

    New Westminster, British Columbia, V3L 3W4

    Recruiting

  • The Ottawa Hospital_Riverside

    Ottawa, Ontario, K1H7W9

    Not yet recruiting

  • Centricity Res Pointe-Claire

    Pointe-Claire, Quebec, H9R 4S3

    Recruiting

  • ALPHA Recherche Clinique

    Québec, Quebec, G3K 2P8

    Completed

  • Recherche Clinique Sigma Inc.

    Québec, G1G 5X1

    Recruiting

  • Diex Recherche Quebec

    Québec, G1V 4T3

    Recruiting

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4

    Recruiting

  • Alpha Recherche Clinique - Lebourgneuf

    Québec, G2J 0C4

    Recruiting

  • Bluewater Clin Res Group Inc

    Sarnia, Ontario, N7T 4X3

    Completed

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec, J1E 0N8

    Completed

  • Centre de Recherche Saint-Louis

    Sherbrooke, Quebec, J1G 1X9

    Recruiting

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec, J6X 4P7

    Recruiting

  • Sewa Ram Singal Medicine Professional Corp

    Toronto, Ontario, M3N 2V6

    Recruiting

  • Centricity Research Toronto

    Toronto, Ontario, M4G 3E8

    Recruiting

  • Centricity Research Toronto Manna Multispec

    Toronto, Ontario, M9W 4L6

    Completed

  • Diex Recherche Trois-Rivieres

    Trois-Rivières, Quebec, G9A 4P3

    Recruiting

  • Diex Recherche Victoriaville

    Victoriaville, Quebec, G6P 3Z8

    Recruiting

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

    Recruiting

Other trials in Canada

Germany23 sites, 21 recruiting

  • Versdias - Diabetologikum Amberg

    Amberg, Bavaria, 92224

    Recruiting

  • Diabetespraxis Mergentheim

    Bad Mergentheim, 97980

    Recruiting

  • Praxis Dr. Stephan Scharla

    Bad Reichenhall, 83435

    Not yet recruiting

  • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

    Berlin, 13597

    Recruiting

  • Studiengesellschaft Dres. Könemann/Steinmann GbR

    Bünde, 32257

    Recruiting

  • Diabetologische Schwerpunktpraxis Daaden

    Daaden, 57567

    Recruiting

  • Diabeteszentrum-Do Dres. K U. Ch. Busch GbR

    Dortmund, 44137

    Recruiting

  • Studienzentrum Dr. Faulmann GbR Dresden

    Dresden, 01279

    Recruiting

  • MVZ Hausärzte Großenbaum GmbH Duisburg

    Duisburg, 47269

    Recruiting

  • Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach

    Eisenach, 99817

    Completed

  • MVZ Contilia GmbH

    Essen, 45219

    Recruiting

  • Praxis am Markt Dr. Becker

    Essen, 45355

    Recruiting

  • MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien

    Fulda, 36037

    Recruiting

  • Diabetes-Zentrum-Wilhelmsburg GbR

    Hamburg, 21109

    Recruiting

  • Mesut Durmaz, Hof

    Hof, 95030

    Recruiting

  • Praxisgemeinschaft Jerichow

    Jerichow, 39319

    Recruiting

  • Familienmedizinisches Zentrum Radowsky

    Leipzig, 04179

    Recruiting

  • Praxis Am Oberen Tor - Dr. Simon-Wagner

    Lichtenfels, 96215

    Recruiting

  • Diabeteszentrum Ludwigsburg

    Ludwigsburg, 71634

    Recruiting

  • Institut für Diabetesforschung Osnabrück

    Osnabrück, 49080

    Recruiting

  • ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim

    Pohlheim, 35415

    Not yet recruiting

  • Hegau-Bodensee-Klinikum Singen

    Singen, 78224

    Completed

  • Dr. Schmidt-Reinwald Astrid, Trier

    Trier, 54292

    Recruiting

Other trials in Germany

Italy13 sites, 13 recruiting

  • A.O.U. Consorziale Policlinico di Bari

    Bari, BA, 70124

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Renato Dulbecco - Mater Domini

    Catanzaro, Calabria, 881100

    Recruiting

  • Università degli studi G. D'Annunzio Chieti Pescara - CAST

    Chieti Scalo, 66100

    Recruiting

  • AST Fermo - Ospedale Murri - Unità Operativa di Diabetologia e Endocrinologia

    Fermo, The Marches, 63900

    Recruiting

  • Azienda Ospedaliero Universitaria Careggi - Diabetologia e malattie del metabolismo

    Florence, Tuscany, 50134

    Recruiting

  • DAI Scienze Mediche - UOSD Diabetologia

    Messina, Sicily, 98124

    Recruiting

  • ASST Fatebenefratelli Ospedale Luigi Sacco - Malattie Endocrine e Diabetologia

    Milan, Lombardy, 20157

    Recruiting

  • AOU Vanvitelli - DAI Medicina Interna, Geriatria e Neurologia - U.O.C. Endocrinologia e Malattie del Metabolismo

    Naples, Campania, 80138

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte

    Palermo, Sicily, 90142

    Recruiting

  • Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia

    Perugia, Umbria, 06129

    Recruiting

  • AUSL Romagna - Medicine Specialistiche Ravenna - UO Servizio di Diabetologia di Ravenna

    Ravenna, 48121

    Not yet recruiting

  • Azienda Ospealiero Universitaria Policlinico Umberto I

    Roma, 00161

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Centro malattie endocrine e metaboliche

    Rome, Lazio, 00168

    Recruiting

Other trials in Italy

About this study

Official title: 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

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.

Being tested
Insulin icodec, Basal insulin analogues
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin icodecDrug

    Insulin icodec will be administered as subcutaneous injection.

  • Basal insulin analoguesDrug

    Basal insulin analogues will be administered as subcutaneous injection.

Study groups in NCT07112339
Study groupRoleWhat they receive
Insulin icodecExperimentalParticipants will receive subcutaneous (s.c) injection of once weekly insulin icodec.
Receives: Drug: Insulin icodec
Basal insulin analoguesActive comparatorParticipants will receive once daily s.c. injection of basal insulin analogues.
Receives: Drug: Basal insulin analogues

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycated haemoglobin (HbA1c)

    Measured as %-point.

    Measured: From baseline week 0 to week 52

Secondary outcomes (7)

  1. Adelphi Adherence Questionnaire (ADAQ©)

    Measured as Score. The ADAQ© score is calculated as the mean of 11 individual items, each rated on a scale from 0 to 4. To obtain the mean score, at least 8 of these items must be answered. A lower score indicates greater adherence.

    Measured: At week 52

  2. Change in Diabetes Treatment Satisfaction Questionnaire- status version(DTSQs) total treatment satisfaction

    Measured as Score of 0-36. DTSQs score ranges from 0 to 36, based on 6 items that are each rated on a scale of 0 to 6. A higher score reflects greater satisfaction with the treatment received.

    Measured: From baseline week 0 to week 52

  3. Treatment Related Impact Measure for Diabetes (TRIM-D) compliance domain

    Measured as Score of 4-20.The score ranges from 4 to 20, based on 4 items rated on a scale of 1 to 5. This score is then transformed to a 0-100 scale, where higher scores indicate better compliance.

    Measured: At week 52

  4. Treatment Related Impact Measure for Diabetes (TRIM-D) treatment burden domain

    Measured as Score of 6-30. The score ranges from 6 to 30, derived from 6 items each rated on a scale of 1 to 5. This score is then transformed to a 0-100 scale, where higher scores indicate less treatment burden.

    Measured: At week 52

  5. Number of severe hypoglycaemic episodes (level 3)

    Measured as Number of episodes.

    Measured: From baseline week 0 to week 52

  6. Mean weekly basal insulin dose

    Measures in Units.

    Measured: From week 50 to week 52

  7. Participant achieved individualised HbA1c target

    Reported as Yes or No.

    Measured: At week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start15 Aug 2025
  3. Primary completion23 Mar 2028 (estimated)
  4. Study completion23 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
586 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07112339
Sponsor's protocol ID
NN1436-7727
Other IDs
U1111-1302-4943, 2024-520068-32
Status last verified
Aug 2026
First submitted
1 Aug 2025
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin icodec and Basal insulin analogues in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 75 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Canada, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glycated haemoglobin (HbA1c) (time frame: From baseline week 0 to week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07112339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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