A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 127
Updated:10/12/2018
Start Date:February 26, 2016
End Date:July 15, 2017

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

A Multi-Center, Randomized, Double-Blind, Active-Controlled , Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered With Dapagliflozin 5mg Compared to Saxagliptin 5mg or Dapagliflozin 5mg All Given as Add-on Therapy to Metformin inPatients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Alone

The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg
co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or
dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin
monotherapy.


Inclusion Criteria:

1. Patients aged ≥18 years old at time of informed consent;

2. Patients with Type 2 diabetes mellitus (T2DM) defined as HbA1C≥7.5% to ≤10.0% at
screening visit;

3. Stable metformin therapy for at least 8 weeks prior to enrolment at a dose of ≥1500mg
per day;

4. BMI ≤45.0kg/m2 at Enrolment visit;

5. Fasting Plasma Glucose (FPG) ≤ 270mg/dl(15.0mmol/L) at the enrolment visit;

6. For Females Only: Women of childbearing potential (WOCBP) must be using an acceptable
method of contraception to avoid pregnancy throughout the study and for at least 4
weeks after the last dose of study medication in such a manner that the risk of
pregnancy is minimized.

Exclusion Criteria:

1. History of diabetes insipidus, Type 1 diabetes or Latent Autoimmune Diabetes of
Adults, diabetic ketoacidosis or hyperosmolar nonketotic coma and Symptoms of poorly
controlled diabetes that would preclude participation in this trial including but not
limited to marked polyuria and polydipsia with greater than 10% weight loss during the
3 months prior to Enrolment (Visit 1), or other signs and symptoms.

2. History of pancreatitis.

3. Administration of any antihyperglycaemic therapy, other than metformin, for more than
14 days (consecutive or not) during the 8 weeks prior to enrolment

4. Any use of DPP-4 inhibitor or SGLT-2 inhibitor within 8 weeks prior to enrolment.

5. Significant hepatic disease, including, but not limited to, chronic active hepatitis
and/or severe hepatic insufficiency and/or significant abnormal liver function,
including patients with Alanine transaminase (ALT) and/or Aspartate transaminase (AST)
≥3x ULN (Upper Limit of Normal)and/or Total Bilirubin ≥2.0x ULN. History of severe
hepatobiliary disease or hepatotoxicity with any medication. Positive serologic
evidence of current infectious liver disease, including patients who are known to be
positive for Hepatitis viral antibody ImmunoglobulinM (IgM), Hepatitis B surface
antigen, and Hepatitis C virus antibody.

6. Moderate or severe impairment of renal function [defined as Estimated Glomerular
Filtration Rate (eGFR) <60milliLitre/min/1.73 m2 (estimated by Modification in Diet
and Renal Disease (MDRD)) or serum creatinine ≥1.5mg/dL in males or ≥1.4mg/dL in
females]. Conditions of congenital renal glucosuria, history of unstable or rapidly
progressing renal disease.

7. History of any clinically significant disease or disorder which, in the opinion of the
investigator, may put the patient at risk because of participation in the study, may
influence the results, or may limit the patient's ability to participate in or
complete the study.
We found this trial at
45
sites
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1306
mi
from
Albany, NY
Click here to add this to my saved trials
858
mi
from
Asheville, NC
Click here to add this to my saved trials
716
mi
from
Biloxi, MS
Click here to add this to my saved trials
1291
mi
from
Bronx, NY
Click here to add this to my saved trials
811
mi
from
Buford, GA
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
810
mi
from
Columbus, OH
Click here to add this to my saved trials
1304
mi
from
Cooper City, FL
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
409
mi
from
Denver, CO
Click here to add this to my saved trials
1314
mi
from
Doral, FL
Click here to add this to my saved trials
East Providence, Rhode Island 02915
1425
mi
from
East Providence, RI
Click here to add this to my saved trials
641
mi
from
El Paso, TX
Click here to add this to my saved trials
635
mi
from
Fargo, ND
Click here to add this to my saved trials
412
mi
from
Florissant, MO
Click here to add this to my saved trials
346
mi
from
Fort Worth, TX
Click here to add this to my saved trials
1210
mi
from
Fresno, CA
Click here to add this to my saved trials
1177
mi
from
Harbor City, CA
Click here to add this to my saved trials
1164
mi
from
Hawaiian Gardens, CA
Click here to add this to my saved trials
600
mi
from
Hazel Crest, IL
Click here to add this to my saved trials
1314
mi
from
Hialeah, FL
Click here to add this to my saved trials
569
mi
from
Houston, TX
Click here to add this to my saved trials
1149
mi
from
Lancaster, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
797
mi
from
Maumee, OH
Click here to add this to my saved trials
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
1778
mi
from
Moncton,
Click here to add this to my saved trials
1137
mi
from
Montclair, CA
Click here to add this to my saved trials
Mooresville, North Carolina 28117
952
mi
from
Mooresville, NC
Click here to add this to my saved trials
697
mi
from
New Orleans, LA
Click here to add this to my saved trials
1181
mi
from
Norfolk, VA
Click here to add this to my saved trials
412
mi
from
Northglenn, CO
Click here to add this to my saved trials
481
mi
from
Odessa, TX
Click here to add this to my saved trials
1140
mi
from
Pomona, CA
Click here to add this to my saved trials
779
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
733
mi
from
Saraland, AL
Click here to add this to my saved trials
Spring Valley, California 91978
1133
mi
from
Spring Valley, CA
Click here to add this to my saved trials
575
mi
from
Sugar Land, TX
Click here to add this to my saved trials
1327
mi
from
Vallejo, CA
Click here to add this to my saved trials
427
mi
from
Waco, TX
Click here to add this to my saved trials
1338
mi
from
Waterbury, CT
Click here to add this to my saved trials
West Columbia, South Carolina 29169
971
mi
from
West Columbia, SC
Click here to add this to my saved trials
414
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials
620
mi
from
Zachary, LA
Click here to add this to my saved trials