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Diabetes Combination Studies Leave Market Challenges Unresolved

 
• By Sue Sutter

Novo Nordisk and Sanofi's trials were intended to satisfy FDA's combination product rule, but sponsors have not addressed some important clinical questions around use of the basal insulin/GLP-1 agonist products.

The clinical trials that Novo Nordisk AS and Sanofi conducted on their respective basal insulin/GLP-1 agonist products may have satisfied regulatory efficacy requirements for combination products, but they stopped short of answering some clinically important questions that could impact prospects for commercial adoption.

Specifically, the companies did not compare the effectiveness of their combination products against separate administration of the insulin component titrated to maximum effect and the maximum effective dose of the...

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