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

2024-520068-32-00 · tracked via the Priya Life Science EU tracker

Sponsor

Novo Nordisk A/S

Sponsor type

Pharmaceutical company

Therapeutic area

Nutritional and Metabolic Diseases

Decision date

05/09/2025

Enrollment target

204

Sites

Germany, Italy

Condition studied

Type 2 diabetes

Investigational medicinal product(s)

Lantus 100 units/ml solution for injection in a cartridgeLantus 100 units/ml solution for injection in a vialToujeo 300 units/ml DoubleStarsolution for injection in a pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penLevemir FlexPen 100 units/ml solution for injection in pre-filled pen.Toujeo 300 units/ml DoubleStarsolution for injection in a pre-filled penTresiba 200 units/mL FlexTouch solution for injection in pre-filled penTresiba 100 units/mL FlexTouch solution for injection in pre-filled penToujeo 300 units/ml SoloStarsolution for injection in a pre-filled penTresiba 200 units/mL FlexTouch solution for injection in pre-filled penTresiba 200 units/mL FlexTouch solution for injection in pre-filled penLantus SoloStar 100 units/ml solution for injection in a pre-filled penLevemir FlexPen 100 units/ml solution for injection in pre-filled pen.Lantus SoloStar 100 units/ml solution for injection in a pre-filled penLantus SoloStar 100 units/ml solution for injection in a pre-filled penLantus SoloStar 100 units/ml solution for injection in a pre-filled penLantus 100 units/ml solution for injection in a vialLantus 100 units/ml solution for injection in a cartridgeAwiqli 700 units/mL solution for injection in pre-filled penLantus 100 units/ml solution for injection in a cartridgeAwiqli 700 units/mL solution for injection in pre-filled penLantus SoloStar 100 units/ml solution for injection in a pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penTresiba 100 units/mL Penfill solution for injection in cartridgeToujeo 300 units/ml SoloStarsolution for injection in a pre-filled penLantus 100 units/ml solution for injection in a cartridgeTresiba 200 units/mL FlexTouch solution for injection in pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penToujeo 300 units/ml DoubleStarsolution for injection in a pre-filled penLevemir FlexPen 100 units/ml solution for injection in pre-filled pen.Toujeo 300 units/ml DoubleStarsolution for injection in a pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penToujeo 300 units/ml SoloStarsolution for injection in a pre-filled penTresiba 100 units/mL FlexTouch solution for injection in pre-filled penLantus 100 units/ml solution for injection in a vialLantus 100 units/ml solution for injection in a vialLantus SoloStar 100 units/ml solution for injection in a pre-filled penTresiba 200 units/mL FlexTouch solution for injection in pre-filled penTresiba 100 units/mL FlexTouch solution for injection in pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penTresiba 100 units/mL Penfill solution for injection in cartridgeLantus 100 units/ml solution for injection in a cartridgeTresiba 200 units/mL FlexTouch solution for injection in pre-filled penLantus SoloStar 100 units/ml solution for injection in a pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penLevemir FlexPen 100 units/ml solution for injection in pre-filled pen.Lantus 100 units/ml solution for injection in a cartridgeToujeo 300 units/ml DoubleStarsolution for injection in a pre-filled penTresiba 100 units/mL FlexTouch solution for injection in pre-filled penToujeo 300 units/ml SoloStarsolution for injection in a pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penLevemir Penfill 100 units/ml solution for injection in cartridge.Levemir Penfill 100 units/ml solution for injection in cartridge.Lantus 100 units/ml solution for injection in a cartridgeLevemir FlexPen 100 units/ml solution for injection in pre-filled pen.Tresiba 200 units/mL FlexTouch solution for injection in pre-filled penLantus SoloStar 100 units/ml solution for injection in a pre-filled penLantus 100 units/ml solution for injection in a vialLantus 100 units/ml solution for injection in a cartridgeAwiqli 700 units/mL solution for injection in pre-filled penTresiba 100 units/mL FlexTouch solution for injection in pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penAwiqli 700 units/mL solution for injection in pre-filled penLevemir Penfill 100 units/ml solution for injection in cartridge.

Eligibility

Age group

65+ years, 18-64 years

Sex

Female, Male

Primary endpoint

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

Endpoint detail

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).

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-520068-32-00 on CTIS ↗ ← All trials in the EU