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Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.
Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

NCT03703869

CompletedN/A

Sponsor: Sanofi

Conditions: Diabetes

Interventions: Insulin glargine (U300)

Countries: Colombia, Egypt, India, Indonesia, Israel, Jordan, Kuwait, Lebanon

Primary Objective: Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c). Secondary Objectives: * Assess effectiveness in achieving glycemic goal measured by HbA1c; * Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ; * Assess requirement for intensification of therapy by additional antidiabetics. * Assess incidence of hypoglycemia; * Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs); * Assess change in body weight.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion criteria :

* Signed patient informed consent;
* Type 2 diabetes mellitus;
* Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months;
* Hemoglobin A1c (HbA1c) \>7.0 % and ≤11% within 3 months of study baseline;
* Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen

Exclusion criteria:

* Diabetes mellitus other than type 2;
* Contraindication to insulin glargine U300 according to local product labelling;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Locations (388)
  • Barranquilla, Colombia
  • Bogotá, Colombia
  • Bogotá, Colombia
  • Cali, Colombia
  • Cali, Colombia
  • Ibague, Colombia
  • Manizales, Colombia
  • Popayán, Colombia
  • Zipaquirá, Colombia
  • Al Mansurah, Egypt
  • Alexandria, Egypt
  • Alexandria, Egypt
  • Alexandria, Egypt
  • Alexandria, Egypt
  • Alexandria, Egypt
  • Cairo, Egypt
  • Cairo, Egypt
  • Cairo, Egypt
  • Cairo, Egypt
  • Cairo, Egypt
  • Giza, Egypt
  • Giza, Egypt
  • Giza, Egypt
  • Giza, Egypt
  • Giza, Egypt
  • Portsaeid, Egypt
  • Ahmedabad, India
  • Ahmedabad, India
  • Ahmedabad, India
  • Ahmedabad, India
  • + 358 more on CT.gov