Evaluation of Toujeo insulin in type 2 diabetes patients inadequately control with their basal insulin treatment

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 19.0Level: 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: EUCTR2015-002416-33-FR
• Lead Sponsor: sanofi-aventis France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-07
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

- Types 2 diabetes adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without GLP1 receptor agonist
- HbA1c > 7,5 %
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Patients with high dose of insulin (>1,2 U/kg)
- Use of prandial insulin
- Change of dose of antidiabetic drugs within the last 8 weeks
- Use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to describe the effect of HOE901-U300 in T2DM patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on HbA1c improvement.;Secondary Objective: - Evolution of fasting plasma glucose <br>- Evolution of insulin dose and body weight<br>- Hpoglycemia incidence<br>- Safety<br>- Patient’s satisfaction when they change their insulin for HOE901-U300<br>- Reach of objective of insulin change, as defined by the investigator<br>- Observance of insulin titration guidelines;Primary end point(s): Mean change of HbA1c;Timepoint(s) of evaluation of this end point: From baseline to week 24