A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients With Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, or With Basal Insulin as Their Only Insulin

CompletadoFase 3ClinicalTrials.gov

ID: NCT02320721Tipo: INTERVENTIONALInicio: 1 de ene de 2015Fin estimado: 1 de may de 2016

Traducción no disponible, mostrando original

Resumen

Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning * Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day * HbA1c change

Descripción detallada

The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period.

Elegibilidad

Edad mínima: 65 YearsSexo: ALL

Criterios de inclusión

Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
Signed informed consent.

Criterios de exclusión

HbA1c at screening visit:
\<7.0% or \>10.0% for participants taking basal insulin.
\<7.5% or \>11.0% for insulin-naïve participants.
History of type 2 diabetes mellitus for less than 1 year before screening.
Participants not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
Change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
Chronic (\>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, e.g. premix insulin; For insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
Cognitive disorder and dementia assessed clinically and by Mini-Mental State Examination (MMSE) score \<24, or any neurologic disorder that would likely affect the participant's ability to follow the study procedure. The participant would be eligible despite an MMSE score \<24 if the investigator determined that the low score reflected educational or cultural background and not dementia as long as the participant was otherwise able to meet the study requirements.
Participants who had end-stage renal disease (\<15 mL/min/1.73m\^2, per estimated Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease (MDRD).
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Intervenciones

drug

Insulin Glargine (HOE901 - U300)

Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).

drug

Insulin Glargine (HOE901 - U100)

Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).

drug

Background therapy

Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.

Ubicaciones

Investigational Site Number 032001

Caba, Argentina

Investigational Site Number 032002

Caba, Argentina

Investigational Site Number 032006

Capital Federal, Argentina

Investigational Site Number 032004

Ciudad Autonoma de Buenos Aire, Argentina

Investigational Site Number 032003

Mar del Plata, Argentina

Patrocinadores

PrincipalSanofi

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