Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in HbA1c and FPG (Fasting Plasma Glucose) from randomization over time and to Core EOP (End of Phase) (only for FPG) per randomized arm [ Time Frame: Randomization, R(randomization)-Week 2, R-Week 4, R-Week 6, R-Week 8, R-Week 10, R-Week 12, R-Week 14, R-Week 16 ]
  The change in HbA1c and FPG from randomization overtime and to the core EOP (only for FPG) will be summarized for each randomized arm.
• Proportion of patients who required anti-diabetic rescue therapy with insulin in the incretin based arm [ Time Frame: Randomization to up to 16 weeks ]
  The proportion of patients who received anti-diabetic rescue therapy in incretin based therapy will be summarized.
• Change in HbA1c and FPG from baseline to Core EOP [ Time Frame: Baseline, Up to 32 weeks ]
  Change in HbA1c and FPG from baseline to Core EOP in patients who received pasireotide by treatment group
• Proportion of patients with ≤ 0.3% HbA1c increase from baseline to Core EOP per randomized arm. [ Time Frame: Baseline, Up to 32 weeks ]
  The proportion of patients with an increase from baseline in HbA1c ≤ 0.3% at Core EOP will be summarized for each randomized arm.
• Safety and tolerability of pasireotide in combination with anti-diabetic treatments [ Time Frame: Up to 32 weeks ]
  Number of adverse drug events, overall and by severity and number of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, vital signs, thyroid function tests and gallbladder examinations
• Incidence of hypoglycemia events [ Time Frame: Up to 32 weeks ]
  Summary of the number of treatment emergent hypoglycemia events, as well as the number of patients with hypoglycemia events.

Original Secondary Outcome:

• Change in HbA1c and FPG (Fasting Plasma Glucose) from randomization over time and to Core EOP (End of Phase) (only for FPG) per randomized arm [ Time Frame: Randomization, R(randomization)-Week 2, R-Week 4, R-Week 6, R-Week 8, R-Week 10, R-Week 12, R-Week 14, R-Week 16 ]
  The change in HbA1c and FPG from randomization overtime and to the core EOP (only for FPG) will be summarized for each randomized arm.
• Proportion of patients who required anti-diabetic rescue therapy with insulin in the incretin based arm [ Time Frame: Randomization to up to 16 weeks ]
  The proportion of patients who received anti-diabetic rescue therapy in incretin based therapy will be summarized.
• Change in HbA1c and FPG from baseline to Core EOP [ Time Frame: Baseline, Up to 32 weeks ]
  Change in HbA1c and FPG from baseline to Core EOP in patients who received pasireotide by treatment group
• Proportion of patients with ≤ 0.3% HbA1c increase from baseline to Core EOP per randomized arm. [ Time Frame: Baseline, Up to 32 weeks ]
  The proportion of patients with an increase from baseline in HbA1c ≤ 0.3% at Core EOP will be summarized for each randomized arm.
• Safety and tolerability of pasireotide and anti-diabetic treatments [ Time Frame: Up to 32 weeks ]
  Number of adverse drug events, overall and by severity and number of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, vital signs, thyroid function tests and gallbladder examinations
• Incidence of hypoglycemia events [ Time Frame: Up to 32 weeks ]
  Summary of the number of treatment emergent hypoglycemia events, as well as the number of patients with hypoglycemia events.

Dates:
Date Received: February 10, 2014
Date Started: May 23, 2014
Date Completion: May 29, 2018
Last Updated: March 24, 2017
Last Verified: March 2017