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非在研适应症- |
最高研发阶段批准上市 |
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首次获批日期2011-04-22 |
A 26-Week, Multi-Center, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-Term Intensive Insulin Therapy: Basal Insulin Based Treatment (With Prandial OADs Combination) Versus Twice-daily Premixed Insulin
Primary Objective:
To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved.
Secondary Objectives:
* To assess efficacy in terms of percentage of patients achieving HbA1c <7% and HbA1c <7% without hypoglycemia.
* To assess efficacy in terms of percentage of patients achieving fasting plasma glucose (FPG) <7 mmol/L and FPG <7 mmol/L without hypoglycemia.
* To assess safety in term of occurrence of moderate/severe hypoglycemia.
* To assess daily blood glucose (BG) variation.
* To assess patient satisfaction.
The Clinical Comparison of Antidiabetic Agents Treating Postprandial Hyperglycemia, between Repaglinide alone and Mitiglide/Voglibose Fixed-dose Combination using Continuous Glucose Monitoring on Postprandial Profiles. - The comparison between glinides and glinides/aGI combination therapy using CGM
Effect of oral hypoglycemic agent for postprandial hyperglycemia administered two times daily on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets - Effect of twice daily administration on glycemic control in patients with type 2 diabetes with Mitiglinide / Voglibose combination tablets.
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