Saxagliptin Triple Oral Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01128153
• Date of registration: 20/05/2010
• Primary sponsor: AstraZeneca
• Public title: Saxagliptin Triple Oral Therapy
• Scientific title: 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
• Date of first enrolment: June 2010
• Target sample size: 257
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01128153
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Australia, Canada, India, Korea, Republic of, Thailand, United Kingdom

Contacts

• Name: Jayanti Visvanthan, MD
• Affiliation: AstraZeneca

• Name: Simon Fisher, MD
• Affiliation: AstraZeneca

• Name: Vinod Mattoo, MD
• Affiliation: Bristol-Myers Squibb

• Name: Robert Moses, MBBS
• Affiliation: Sydney Diabetes Centre

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: Placebo

Drug: Saxagliptin

Primary Outcome(s)

Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF) [Time Frame: From Baseline to Week 24 weeks]

Secondary Outcome(s)

Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL] [Time Frame: From Baseline to Week 24]

Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L] [Time Frame: From Baseline to Week 24]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL] [Time Frame: From Baseline to Week 24]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L] [Time Frame: From Baseline to Week 24]

Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF) [Time Frame: From Baseline to Week 24]

Secondary ID(s)

CV181-117

D1680L00006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb