6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients with Type 2 Diabetes Mellitus not Adequately Controlled with Non-Insulin Antihyperglycemic Drugs with a 6-month Safety Extension Period - EDITION III

sanofi-aventis recherche & développement0 个研究点目标入组 1,200 人开始时间: 2012年8月30日最近更新: 2014年6月30日

试验速览

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•- Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);
•- Signed written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 900
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•- HbA1c < 7.0% (< 53 mmol/mol) or > 11% (> 97 mmol/mol) [at screening];
•- History of type 2 diabetes mellitus for less than 1 year before screening;
•- Less than 6 months before screening with non-insulin antihyperglycemic treatment;
•- Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening;
•- Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of GLP-1 receptor agonist in the last 6 months before screening visit;
•- Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinides are to be discontinued at baseline);
•- Current or previous insulin use except for a maximum of 8 consecutive days (e.g. acute illness, surgery) during the last year prior to screening;
•- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (e.g. laser, surgical treatment or injectable drugs) during the study period.

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