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Completed Phase 3 Interventional Results available

Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

ClinicalTrials.gov ID: NCT00885378

Public ClinicalTrials.gov record NCT00885378. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 11:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00885378
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
166 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 78 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2009 (Type not available)
Primary completion
Feb 2010 (Actual)
Completion
Feb 2010 (Actual)
Last update posted
Jun 1, 2015

2009 – 2010

United States locations

U.S. sites
25
U.S. states
13
U.S. cities
25
Facility City State ZIP Site status
John Muir Physician Network Clinical Research Center Concord California 94520 —
Southland Clinical Research Center, Inc. Fountain Valley California 92708 —
Torrance Clinical Research Lomita California 90717 —
Ritchken & First M.D.'S San Diego California 92117 —
Central Florida Clinical Trials, Inc. Altamonte Springs Florida 32701 —
Family Care Associates Of Nw Florida Chipley Florida 32428 —
Clinical Therapeutics Corporation Coral Gables Florida 33134 —
Nextphase Clinical Trials, Inc. Miami Florida 33145 —
Middle Georgia Drug Study Center, Llc Perry Georgia 31069 —
Louisiana Heart Center Research Slidell Louisiana 70458 —
Jackson Clinic Rolling Fork Mississippi 39159 —
Community Health Care Of Manchester Akron Ohio 44319 —
Midwest Regional Research, Inc. Bellbrook Ohio 45305 —
Wells Institute For Health Awareness Kettering Ohio 45429 —
Newark Physician Associates Newark Ohio 43055 —
Integris Family Care South Oklahoma City Oklahoma 73170 —
Integris Family Care Yukon Yukon Oklahoma 73099 —
Williamette Valley Clinical Studies Eugene Oregon 97404 —
Integrated Medical Group Pc/Fleetwood Clinical Research Fleetwood Pennsylvania 19522 —
Southeastern Research Associates, Inc Taylors South Carolina 29687 —
Holston Medical Group Kingsport Tennessee 37660 —
Village Family Practice Houston Texas 77024 —
Southwest Clinical Research Centers, Llc Pearland Texas 77584 —
Jolene K. Berg, Md., Dgd Research, Inc. San Antonio Texas 78229 —
Tidewater Integrated Medical Research Virginia Beach Virginia 23454 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00885378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 1, 2015 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00885378 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →