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
Conditions
Interventions
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 - U30
Sponsors
Sanofi S.p.A.
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactCONTACT POINT
Sanofi S.p.A.
Outcome results
None listed