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

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

Overview

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.

Interventions

• Drug Insulin icodec
  Insulin icodec will be administered as subcutaneous injection.
• Drug Basal insulin analogues
  Basal insulin analogues will be administered as subcutaneous injection.

Primary outcome measures

• Change in glycated haemoglobin (HbA1c) [Time frame: From baseline week 0 to week 52]

Secondary outcome measures (7)

• Adelphi Adherence Questionnaire (ADAQ©) [Time frame: At week 52]
• Change in Diabetes Treatment Satisfaction Questionnaire- status version(DTSQs) total treatment satisfaction [Time frame: From baseline week 0 to week 52]
• Treatment Related Impact Measure for Diabetes (TRIM-D) compliance domain [Time frame: At week 52]
• Treatment Related Impact Measure for Diabetes (TRIM-D) treatment burden domain [Time frame: At week 52]
• Number of severe hypoglycaemic episodes (level 3) [Time frame: From baseline week 0 to week 52]
• Mean weekly basal insulin dose [Time frame: From week 50 to week 52]
• Participant achieved individualised HbA1c target [Time frame: At week 52]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 39 centers

• Centricity Research Calgary Endocrinology — Calgary
• Alta Clinical Research at Hermitage Medicentre — Edmonton
• Fraser Clinical Trials Inc. — New Westminster
• Winnipeg Clinic — Winnipeg
• G.A. Research Associates Ltd. — Moncton
• Centricity Research Brampton Endocrinology — Brampton
• Centricity Clinical Research Burlington — Burlington
• Centricity Research Vaughn Endocrinology — Concord
• … and 31 more centers

Germany · 23 centers

• Versdias - Diabetologikum Amberg — Amberg
• Diabetespraxis Mergentheim — Bad Mergentheim
• Praxis Dr. Stephan Scharla — Bad Reichenhall
• Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR — Berlin
• Studiengesellschaft Dres. Könemann/Steinmann GbR — Bünde
• Diabetologische Schwerpunktpraxis Daaden — Daaden
• Diabeteszentrum-Do Dres. K U. Ch. Busch GbR — Dortmund
• Studienzentrum Dr. Faulmann GbR Dresden — Dresden
• … and 15 more centers

Italy · 13 centers

• A.O.U. Consorziale Policlinico di Bari — Bari
• Azienda Ospedaliero Universitaria Renato Dulbecco - Mater Domini — Catanzaro
• AOU Vanvitelli - DAI Medicina Interna, Geriatria e Neurologia - U.O.C. Endocrinologia e Ma — Naples
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Centro malattie endocrine e — Rome
• DAI Scienze Mediche - UOSD Diabetologia — Messina
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte — Palermo
• AST Fermo - Ospedale Murri - Unità Operativa di Diabetologia e Endocrinologia — Fermo
• Azienda Ospedaliero Universitaria Careggi - Diabetologia e malattie del metabolismo — Florence
• … and 5 more centers

Identifiers

NCT: NCT07112339 · NN1436-7727 · U1111-1302-4943 · 2024-520068-32

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗