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

AstraZeneca1 site in 1 country257 target enrollmentJune 2010

ConditionsType 2 Diabetes

InterventionsSaxagliptin Placebo

DrugsSaxagliptin Placebo

Overview

Phase: Phase 3
Intervention: Saxagliptin
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Enrollment: 257
Locations: 1
Primary Endpoint: Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

June 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility 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
•Creatine kinase \> or = 10 x ULN at Visit 2

Arms & Interventions

Saxagliptin 5 mg once daily

Intervention: Saxagliptin

Placebo once daily

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: From Baseline to Week 24 weeks

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

Secondary Outcomes

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