Saxagliptin Triple Oral Therapy

AstraZeneca257 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

257

Conditions

Type 2 Diabetes

Interventions

SaxagliptinDRUG

5 mg tablet once daily for 24 weeks to be taken orally

PlaceboDRUG

tablet once daily for 24 weeks to be taken orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (33)

Outcomes

Primary Outcomes

Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)

Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model

Time frame: From Baseline to Week 24 weeks

Secondary Outcomes

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

Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model