Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 77
Updated:10/14/2017
Start Date:August 2005
End Date:February 2010

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"

The purpose of this clinical research study is to learn whether Saxagliptin added to
Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic
subjects who are not sufficiently controlled with Metformin alone

All subjects will participate in a lead-in period, and qualifying subjects will continue into
a short-term randomized treatment period. Subjects who complete the short-term period will be
eligible to enter the long term extension period. Also, subjects in the short-term period who
have an elevated blood sugar that requires additional medication for blood sugar control will
be eligible to enter the long-term treatment extension period where they will receive
pioglitizone added onto their blinded study medication

Inclusion Criteria:

- Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater
than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks
prior to screening.

- HbA1c >= 7.0% and <= 10.0 %

- Body mass index <= 40 kg/m2

- Fasting C-peptide >= 1 ng/dL

Exclusion Criteria:

- Symptomatic poorly controlled diabetes

- Recent cardiac or cerebrovascular event

- Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females
We found this trial at
96
sites
Local Institution
2675 North Decatur Road
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Local Institution
Albuquerque, New Mexico 87108
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Local Institution
773 Douglas Avenue
Altamonte Springs, Florida 32714
?
mi
from
Altamonte Springs, FL
Click here to add this to my saved trials
Local Institution
1821 Mc Call Drive
Anniston, Alabama 36207
?
mi
from
Anniston, AL
Click here to add this to my saved trials
Local Institution
Athens, Ohio 45701
?
mi
from
Athens, OH
Click here to add this to my saved trials
Local Institution
Austin, Texas 78701
?
mi
from
Austin, TX
Click here to add this to my saved trials
Local Institution
Baltimore, Maryland 21237
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Local Institution
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Local Institution
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials
Local Institution
Bristol, Tennessee 37620
?
mi
from
Bristol, TN
Click here to add this to my saved trials
Local Institution
3100 Texas 47
Bryan, Texas 77807
?
mi
from
Bryan, TX
Click here to add this to my saved trials
Local Institution
100 Calera Eagle Drive
Calera, Alabama 35040
?
mi
from
Calera, AL
Click here to add this to my saved trials
Local Institution
49 Brookwood Avenue
Carlisle, Pennsylvania 17015
?
mi
from
Carlisle, PA
Click here to add this to my saved trials
Local Institution
1925 East Belt Line Road
Carrollton, Texas 75006
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
Local Institution
5254 North Meadows Drive
Castle Rock, Colorado 80109
?
mi
from
Castle Rock, CO
Click here to add this to my saved trials
Local Institution
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Local Institution
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Local Institution
Chester, Maryland
?
mi
from
Chester, MD
Click here to add this to my saved trials
Local Institution
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Local Institution
1331 South Blvd
Chipley, Florida 32428
?
mi
from
Chipley, FL
Click here to add this to my saved trials
Local Institution
3300 North Atlantic Avenue
Cocoa Beach, Florida 32931
?
mi
from
Cocoa Beach, FL
Click here to add this to my saved trials
Local Institution
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Local Institution
Columbus, Ohio 43219
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Local Institution
Coral Gables, Florida 33134
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Local Institution
Dallas, Texas 75246
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Local Institution
Denver, Colorado 80220
?
mi
from
Denver, CO
Click here to add this to my saved trials
Local Institution
100 South Danzler Road
Duncan, South Carolina 29334
?
mi
from
Duncan, SC
Click here to add this to my saved trials
Local Institution
2608 California Road
Elkhart, Indiana 46514
?
mi
from
Elkhart, IN
Click here to add this to my saved trials
Local Institution
5535 Balboa Boulevard
Encino, California 91316
?
mi
from
Encino, CA
Click here to add this to my saved trials
Local Institution
868 High Street
Eugene, Oregon 97401
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Local Institution
Fort Lauderdale, Florida 33309
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Local Institution
Fountain Valley, California
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Local Institution
Fresno, California 93720
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Local Institution
Golden, Colorado 80401
?
mi
from
Golden, CO
Click here to add this to my saved trials
Local Institution
Greensboro, North Carolina 27405
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Local Institution
2001 20th Street
Haleyville, Alabama 35565
?
mi
from
Haleyville, AL
Click here to add this to my saved trials
Local Institution
100 East Queen Street
Hampton, Virginia 23668
?
mi
from
Hampton, VA
Click here to add this to my saved trials
Local Institution
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Local Institution
Iowa City, Iowa 52242
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Local Institution
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Local Institution
2405 Aggie Road
Jonesboro, Arkansas 72401
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
Local Institution
200 Commons Way
Kalispell, Montana 59901
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
Local Institution
Kansas City, Missouri 64108
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Local Institution
4727 West Irlo Bronson Memorial Highway
Kissimmee, Florida 34746
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Local Institution
1400 Teal Road West
Lafayette, Indiana 47905
?
mi
from
Lafayette, IN
Click here to add this to my saved trials
Local Institution
Langhorne, Pennsylvania 19047
?
mi
from
Langhorne, PA
Click here to add this to my saved trials
Local Institution
Las Vegas, Nevada 89106
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Local Institution
2019 Edgely Road
Levittown, Pennsylvania 19057
?
mi
from
Levittown, PA
Click here to add this to my saved trials
Local Institution
Lexington, Kentucky 40536
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Local Institution
Little Rock, Arkansas 72201
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Local Institution
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Local Institution
1900 North Boise Avenue
Loveland, Colorado 80538
?
mi
from
Loveland, CO
Click here to add this to my saved trials
Local Institution
1876 South Green Road
Lyndhurst, Ohio 44121
?
mi
from
Lyndhurst, OH
Click here to add this to my saved trials
Local Institution
3350 Deán Funes
Mar Del Plata, Buenos Aires B7602
?
mi
from
Mar Del Plata,
Click here to add this to my saved trials
Local Institution
3625 F C I Road
Marianna, Florida 32446
?
mi
from
Marianna, FL
Click here to add this to my saved trials
Local Institution
Mesa, Arizona 85206
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Local Institution
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Local Institution
26726 Crown Valley Parkway
Mission Viejo, California 92691
?
mi
from
Mission Viejo, CA
Click here to add this to my saved trials
Local Institution
3431 Arendell Street
Morehead City, North Carolina 28557
?
mi
from
Morehead City, NC
Click here to add this to my saved trials
Local Institution
Munfordville, Kentucky
?
mi
from
Munfordville, KY
Click here to add this to my saved trials
Local Institution
New Orleans, Louisiana 70118
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Local Institution
New Port Richey, Florida 34652
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
Local Institution
18250 Roscoe Boulevard
Northridge, California 91325
?
mi
from
Northridge, CA
Click here to add this to my saved trials
Local Institution
Ocala, Florida 34474
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Local Institution
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Local Institution
1620 4th Avenue East
Olympia, Washington 98506
?
mi
from
Olympia, WA
Click here to add this to my saved trials
Local Institution
Omaha, Nebraska 68114
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Local Institution
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Local Institution
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Local Institution
Phoenix, Arizona 85016
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Local Institution
Pittsburgh, Pennsylvania 15240
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Local Institution
Portland, Oregon 97201
?
mi
from
Portland, OR
Click here to add this to my saved trials
Local Institution
850 Costley Way
Prince Frederick, Maryland 20678
?
mi
from
Prince Frederick, MD
Click here to add this to my saved trials
Local Institution
548 Gibson Drive
Roseville, California 95678
?
mi
from
Roseville, CA
Click here to add this to my saved trials
Local Institution
Sacramento, California 95819
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Local Institution
Salisbury, North Carolina 28144
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
Local Institution
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Local Institution
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Local Institution
6929 J.F.K. Boulevard
Sherwood, Arkansas 72116
?
mi
from
Sherwood, AR
Click here to add this to my saved trials
Local Institution
404 Trojan Avenue
Sparta, North Carolina 28675
?
mi
from
Sparta, NC
Click here to add this to my saved trials
Local Institution
Spokane, Washington 99216
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Local Institution
3230 Sweetwater Springs Boulevard
Spring Valley, California 91977
?
mi
from
Spring Valley, CA
Click here to add this to my saved trials
Local Institution
St. Louis, Missouri 63110
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Local Institution
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Local Institution
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Local Institution
Temple, Texas 76508
?
mi
from
Temple, TX
Click here to add this to my saved trials
Local Institution
2363 Lakewood Road
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Local Institution
3107 Southwest 21st Street
Topeka, Kansas 66604
?
mi
from
Topeka, KS
Click here to add this to my saved trials
Local Institution
Tulsa, Oklahoma 74136
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Local Institution
17632 Irvine Boulevard
Tustin, California 92780
?
mi
from
Tustin, CA
Click here to add this to my saved trials
Local Institution
145 Lakeview Parkway
Vernon Hills, Illinois 60061
?
mi
from
Vernon Hills, IL
Click here to add this to my saved trials
Local Institution
4500 Main Street
Virginia Beach, Virginia 23462
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
Local Institution
Waterloo, Iowa 50702
?
mi
from
Waterloo, IA
Click here to add this to my saved trials
Local Institution
501 Natchitoches Street
West Monroe, Louisiana 71291
?
mi
from
West Monroe, LA
Click here to add this to my saved trials
Local Institution
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Local Institution
Winston Salem, North Carolina 27103
?
mi
from
Winston Salem, NC
Click here to add this to my saved trials