A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination With Metformin IR in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone

AstraZeneca26 sites in 2 countries166 target enrollmentMay 2009

ConditionsType 2 Diabetes Mellitus

InterventionsSaxagliptin plus metformin IR Placebo plus metformin IR

DrugsSaxagliptin plus metformin IR Placebo plus metformin IR

Overview

Phase: Phase 3
Intervention: Saxagliptin plus metformin IR
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Enrollment: 166
Locations: 26
Primary Endpoint: Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

February 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 2 diabetes
•18-78 years of age
•Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
•A1C: 7-10%
•C-peptide: ≥ 0.8 ng/mL
•Body mass index (BMI): ≤45 kg/m\^2

Exclusion Criteria

•Women of childbearing potential unable or unwilling to use acceptable birth control
•Women who are pregnant or breastfeeding
•Fasting plasma glucose (FPG) \>270 mg/dL
•Significant cardiovascular history
•Symptoms of poorly controlled diabetes
•History of diabetic ketoacidosis or hyperosmolar nonketotic coma
•Insulin therapy within one year of screening
•Cardiovascular even within the prior 6 months
•New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction \<=40%
•Significant history of renal or hepatic disease

Arms & Interventions

Saxagliptin plus metformin IR

Intervention: Saxagliptin plus metformin IR

Placebo plus metformin IR

Intervention: Placebo plus metformin IR

Outcomes

Primary Outcomes

Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12

Time Frame: Baseline, Week 12

Mean change was adjusted for baseline.

Secondary Outcomes

Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline, Week 12)
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12(Week 12)
Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12(Week 12)