|
|
|
|
|
Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date22 Apr 2011 |
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.
/ CompletedNot ApplicableIIT 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
/ CompletedNot ApplicableIIT 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.
Start Date31 May 2016 |
Sponsor / Collaborator- |
100 Clinical Results associated with MGAM x VGKCs
100 Translational Medicine associated with MGAM x VGKCs
0 Patents (Medical) associated with MGAM x VGKCs