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Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment
Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment

NCT02967237

CompletedPhase 4

Sponsor: Sanofi

Conditions: Diabetes Mellitus, Type 2

Interventions: insulin glargine (U300)

Countries: France

Primary Objective: The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement. Secondary Objectives: * Evolution of fasting plasma glucose * Evolution of insulin dose and body weight * Hypoglycemia incidence * Safety * Patients satisfaction when they change their insulin for HOE901-U300

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria :

* Type 2 diabetic adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without glucagon-like peptide-1 (GLP-1) receptor agonist
* HbA1c \> 7.5%

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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Locations (85)
  • Alençon, France
  • Alès, France
  • Amiens, France
  • Amilly, France
  • Bagnols-sur-Cèze, France
  • Bar-le-Duc, France
  • Besançon, France
  • Béthune, France
  • Bondy, France
  • Brest, France
  • Brest, France
  • Cahors, France
  • Cannes, France
  • Chambéry, France
  • Châlons-en-Champagne, France
  • Cholet, France
  • Clermont-Ferrand, France
  • Cognac, France
  • Colmar, France
  • Contamines Sur Arve, France
  • Coudray, France
  • Dijon, France
  • Eaubonne, France
  • Étampes, France
  • Grenoble, France
  • La Roche-sur-Yon, France
  • La Rochelle, France
  • La Seyne-sur-Mer, France
  • Lamagistère, France
  • Le Chesnay, France
  • + 55 more on CT.gov