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Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin
Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin

NCT03760991

CompletedPhase 4

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

Interventions: INSULIN GLARGINE (U300)

Countries: Argentina, Colombia, Egypt, Hong Kong, India, Indonesia, Lebanon, Malaysia

Primary Objective: To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal insulin following the switch to Gla-300. Secondary Objectives: To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health care resource utilization (HCRU) outcomes. To evaluate the safety of Gla-300.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria :

* Participants with type 2 diabetes mellitus.
* Participants on "standard of care" basal insulin therapy administered once or twice daily, as per labeling for at least 6 months prior to screening visit, with or without other antidiabetics approved for using with insulin.
* Glycated hemoglobin (HbA1c) between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.
* Fasting plasma glucose values above 130 mg/dL.

Exclusion criteria:

* Unstable basal insulin regimen in the last 8 weeks prior to screening visit (ie, type of insulin and time/frequency of the injection, insulin doses \[variation more than ±20%\]).
* Treatment with insulin other than basal insulin: mixed insulin (premixes), rapid insulin, fast acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Locations (14)
  • Buenos Aires, Argentina
  • Colombia, Colombia
  • Egypt, Egypt
  • Hong Kong, Hong Kong
  • India, India
  • Indonesia, Indonesia
  • Lebanon, Lebanon
  • Putrajaya, Malaysia
  • Hacienda Perú, Peru
  • Philippines, Philippines
  • Saudi Arabia, Saudi Arabia
  • South Africa, South Africa
  • Thailand, Thailand
  • Turkey, Turkey (Türkiye)