Completed

SCORESaxagliptin and Metformin XR Combination for Type 2 Diabetes Glycemic Control

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Study Aim

This study aims to evaluate the effectiveness of combining Saxagliptin and Metformin XR in controlling blood sugar levels, as measured by the change in HbA1c from the start to the 18th week, in individuals with Type 2 Diabetes.

What is being tested

Saxagliptin

+ Metformin XR

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 78 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2009
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2009

Actual date on which the first participant was enrolled.

The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.

Official Title18-Week, Multicenter, Randomized, Double-Blind 3b Trial to Evaluate Efficacy/Safety of Saxagliptin in Combo With Metformin XR 1500mg vs Metformin Uptitrated to 2000mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control After Diet/Exercise and a Stable Dose of Metformin XR 1500mg
NCT00960076
Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

282 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 78 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

3 inclusion criteria required to participate
Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less than or equal to 1500mg only for at least 8 weeks prior to screening
A1c: 7.5-11% (at screening)
BMI less than or equal to 45 kg/m2
2 exclusion criteria prevent from participating
Significant cardiovascular history
Active liver disease, renal impairment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Saxagliptin

Group II

Active Comparator
Metformin Extended Release

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 35 locations

Suspended

Research Site

Jonesboro, United StatesOpen Research Site in Google Maps
Suspended

Research Site

Anaheim, United States
Suspended

Research Site

Fountain Valley, United States
Suspended

Research Site

Los Angeles, United States
Completed35 Study Centers