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Insulin glulisine. Aventis Pharma.

Daniela Barlocco¹

¹Istituto di Chimica Farmaceutica e Tossicologica, University of Milan, Viale Abruzzi 42, 20131 Milan, Italy. daniela.barlocco@unimi.it

Current Opinion in Investigational Drugs (London, England : 2000)

|December 3, 2003

Summary

Aventis Pharma is developing insulin glulisine, a fast-acting insulin analog, for treating hyperglycemia in type 1 and type 2 diabetes. Regulatory submissions have been made to the FDA and EMEA for this novel diabetes treatment.

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Area of Science:

Pharmacology
Endocrinology
Metabolic Disorders

Background:

Hyperglycemia is a common complication in both type 1 and type 2 diabetes mellitus.
Effective glycemic control is crucial for preventing long-term diabetic complications.
Fast-acting insulin analogs offer potential advantages in mimicking physiological insulin secretion patterns.

Purpose of the Study:

To evaluate the efficacy and safety of insulin glulisine for managing hyperglycemia.
To assess the potential of insulin glulisine as a treatment option for diabetic patients.

Main Methods:

Insulin glulisine, a rapid-acting insulin analog, is under development by Aventis Pharma.
Regulatory submissions, including a New Drug Application (NDA) to the FDA and a Marketing Authorisation Application (MAA) to the EMEA, have been filed.

Main Results:

The development focuses on insulin glulisine's role in managing hyperglycemia.
The drug is intended for patients with type 1 and type 2 diabetes.

Conclusions:

Insulin glulisine represents a potential new therapeutic option for diabetes management.
The submitted regulatory applications indicate progress towards potential market approval.

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