studio di fase IV, della durata di 24 settimane che ha lo scopo di dimostrare la non inferiorità di un algoritmo con gestione del paziente rispetto a quello con gestione del medico per la titolazione di insulina glargine 300U/ml (HOE901-U300)

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 18.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-001167-39-IT
• Lead Sponsor: Sanofi S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-21
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 562

Inclusion Criteria

• Adult patients with type 2 diabetes mellitus (for at least 1 year).
• Willingness/ability to self-manage titration algorithm.
• HbA1c = 7.5 and = 10.0%.
• Insulin naïve, treated with Oral Anti-Diabetics (OADs). Patients must be willing to interrupt treatment with sulfonylurea/glinides at randomization.
• Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

• Type 1 diabetes.
• Age <18 years.
• Treated with insulin.
• Not willing to stop sulfonylurea or glinides.
• Known hypersensitivity / intolerance to insulin glargine or any of its excipients.
• Pregnant and breastfeeding women.
• Women of childbearing potential not using highly-effective birth control methods or not willing to be tested for pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified