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 - SENIOR

Sanofi-aventis recherche & développement0 个研究点目标入组 920 人开始时间: 2014年12月9日最近更新: 2016年8月16日

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•Patients =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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 920

•HbA1c at screening visit:
•- <7.0% or >10.0% for patients taking basal insulin.
•- <7.5% or >11.0% for insulin-naïve patients.
•History of type 2 diabetes mellitus for less than 1 year before screening.
•Patients 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, eg, 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 will likely affect the patient’s ability to follow the study procedure. The patient will be eligible despite an MMSE score <24 if the investigator determines that the low score reflects educational or cultural background and not dementia as long as the patient is otherwise able to meet the study requirements.
•Patients who have 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]).

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