A Multicenter, Multinational, Prospective, Interventional, Single-arm, Phase IV Study Evaluating the Clinical Efficacy and Safety of 26 Weeks of Treatment With Insulin Glargine 300 U/mL (Gla-300) in Patients With Type 2 Diabetes Mellitus Uncontrolled on Basal Insulin

CompletadoFase 4ClinicalTrials.gov

ID: NCT03760991Tipo: INTERVENTIONALInicio: 18 de dic de 2018Fin estimado: 23 de sept de 2020

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

Study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at Week 27.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

INSULIN GLARGINE (U300)

Pharmaceutical form: Solution for injection in a prefilled pen Route of administration: Subcutaneous

Ubicaciones

Investigational site Argentina

Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi

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