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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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520068-32-00
Acronym
NN1436-7727
Enrollment
204
Registered
2025-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Brief summary

Change in HbA1c from baseline week 0 (V2) to week 52 (V6).

Detailed description

Adelphi Adherence Questionnaire (ADAQ©) At week 52 (V6)., Change in DTSQs in total treatment satisfaction from baseline week 0 (V2) to week 52 (V6)., TRIM-D compliance domain at week 52 (V6)., TRIM-D treatment burden domain at week 52 (V6)., Number of severe hypoglycaemic episodes (level 3) from baseline week 0 (V2) to week 52 (V6)., Mean weekly basal insulin dose from week 50 to week 52 (V6)., Participant achieved individualised HbA1c target at week 52 (V6).

Interventions

DRUGTresiba 100 units/mL FlexTouch solution for injection in pre-filled pen
DRUGAwiqli 700 units/mL solution for injection in pre-filled pen
DRUGTresiba 200 units/mL FlexTouch solution for injection in pre-filled pen
DRUGLantus 100 units/ml solution for injection in a cartridge
DRUGLevemir FlexPen 100 units/ml solution for injection in pre-filled pen.
DRUGToujeo 300 units/ml SoloStar
DRUGsolution for injection in a pre-filled pen
DRUGLantus SoloStar 100 units/ml solution for injection in a pre-filled pen
DRUGToujeo 300 units/ml DoubleStar
DRUGTresiba 100 units/mL Penfill solution for injection in cartridge
DRUGLantus 100 units/ml solution for injection in a vial
DRUGLevemir Penfill 100 units/ml solution for injection in cartridge.

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in HbA1c from baseline week 0 (V2) to week 52 (V6).—

Secondary

MeasureTime frame
Adelphi Adherence Questionnaire (ADAQ©) At week 52 (V6)., Change in DTSQs in total treatment satisfaction from baseline week 0 (V2) to week 52 (V6)., TRIM-D compliance domain at week 52 (V6)., TRIM-D treatment burden domain at week 52 (V6)., Number of severe hypoglycaemic episodes (level 3) from baseline week 0 (V2) to week 52 (V6)., Mean weekly basal insulin dose from week 50 to week 52 (V6)., Participant achieved individualised HbA1c target at week 52 (V6).—

Countries

Germany, Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026