Saxagliptin Triple Oral Therapy

Phase 3

Completed

Brief Summary: The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.

Detailed Description: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea

Recruitment & Eligibility

Inclusion Criteria

Written Informed Consent
Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c > or = 7% and < or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to Visit 1
BMI < or = 40 kg/m2

Exclusion Criteria

Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with > 10% weight loss in 3 months prior to entry, or other signs and symptoms
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
Estimated CrCl < 60 ml/min at Visit 2
CHF (NYHA class III or IV) and/or LVEF <40%
Active liver disease and/or significant abnormal liver function defined as AST and/or ALT > 3 x ULN and/or bilirubin > 2.0 mg/dL at Visit 2.
Creatine kinase > or = 10 x ULN at Visit 2

Arm && Interventions

Group	Intervention	Description
Saxagliptin 5 mg once daily	Saxagliptin	-
Placebo once daily	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)	From Baseline to Week 24 weeks	Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]	From Baseline to Week 24	Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]	From Baseline to Week 24	Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]	From Baseline to Week 24	Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]	From Baseline to Week 24	Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model
Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)	From Baseline to Week 24	Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24