A Randomised, Double-blind, Double-dummy, Active-comparator Controlled Study Investigating the Efficacy and Safety of Linagliptin Co-administered With Metformin QD at Evening Time Versus Metformin BID Over 14 Weeks in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

简要总结

主要结局

次要结局

• Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment(14 weeks)
• Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks(14 weeks)
• Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment)(14 weeks)
• Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment(14 weeks)
• Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators(14 weeks)
• Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment)(14 weeks)
• Change From Baseline in Body Weight by Visit at Week 14(Baseline and 14 weeks)
• Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment(Baseline and 14 weeks)
• Change From Baseline in HbA1c Over Time(Baseline, 2 weeks and 8 weeks)
• Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment(14 weeks)
• Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment(14 weeks)
• Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks(14 weeks)