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)

• Register: EUCTR
• Last refreshed on: 19 February 2018
• Main ID: EUCTR2015-001167-39-IT
• Date of registration: 21/04/2015
• Prospective Registration: Yes
• Primary sponsor: Sanofi S.p.A.
• Public title: 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)
• Scientific title: Studio nazionale, randomizzato, controllato, in aperto, a gruppi paralleli per confrontare l’efficacia e la sicurezza di due diversi approcci con algoritmo di titolazione (gestito dal medico vs gestito dal paziente) per una nuova terapia con insulina glargine U300 in pazienti con diabete di tipo 2 - Studio italiano di approccio alla titolazione
• Date of first enrolment: 01/06/2015
• Target sample size: 562
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001167-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: algorithm managed by physician compared to algorithm managed by patient; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Italy

Contacts

• Name: CONTACT POINT
• Affiliation: Sanofi S.p.A.

• Name: CONTACT POINT
• Affiliation: Sanofi S.p.A.

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus
MedDRA version: 18.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: insulina glargina
Product Code: HOE901 - U300
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Current Sponsor code: HOE901 - U300
Other descriptive name: Insulina glargine U300
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Secondary Objective: The secondary objective of the study is to compare the two titration approaches in terms of:
• Frequency of occurrence of hypoglycemia.
• Changes in Fasting Plasma Glucose (FPG), mean 24-hour self-monitored plasma glucose (SMPG) (mmol/L; based on 7-point SMPG).
• Changes in insulin dose.
• Changes in body weight.
• Percentage of patients at glycated hemoglobin (HbA1c) target.
• Percentage of patients at HbA1c target without hypoglycemia.
• Percentage of patients at HbA1c target without hypoglycemia and weight increase.
• Patient/physician adherence to titration algorithm and correlation with glycemic control.
• Diabetes related distress.
• Diabetes Empowerment.
• Treatment satisfaction.
• Safety and tolerability.

Main Objective: The primary objective of this study is to demonstrate the non-inferiority, in terms of glycemic control, of a patient-managed (nurse assisted) versus a physician-managed algorithm for titrating Insulin glargine 300U/ml (HOE901-U300) in insulin naïve type 2 diabetes mellitus (T2DM) patients inadequately controlled with oral antidiabetic agents.

Primary end point(s): The primary efficacy endpoint is the change in HbA1c from baseline to endpoint (Week 24) (delta HbA1c 0.3% non-inferiority margin).

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome(s)

Secondary end point(s): The principal secondary endpoint is the incidence (%) of participants with at least one confirmed (=3.9 mmol/L [70 mg/dL]) and/or severe nocturnal (00.00 to 05.59) hypoglycemic

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary ID(s)

GLARGL07537

Source(s) of Monetary Support

Sanofi S.p.A.