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
Mooresville, North Carolina 28117
2099
mi
from 91732
Mooresville, NC
Click here to add this to my saved trials
2437
mi
from 91732
Albany, NY
Click here to add this to my saved trials
2002
mi
from 91732
Asheville, NC
Click here to add this to my saved trials
1710
mi
from 91732
Biloxi, MS
Click here to add this to my saved trials
2436
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
1936
mi
from 91732
Buford, GA
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
2309
mi
from 91732
Cooper City, FL
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
817
mi
from 91732
Denver, CO
Click here to add this to my saved trials
2314
mi
from 91732
Doral, FL
Click here to add this to my saved trials
East Providence, Rhode Island 02915
2564
mi
from 91732
East Providence, RI
Click here to add this to my saved trials
686
mi
from 91732
El Paso, TX
Click here to add this to my saved trials
1400
mi
from 91732
Fargo, ND
Click here to add this to my saved trials
1567
mi
from 91732
Florissant, MO
Click here to add this to my saved trials
1194
mi
from 91732
Fort Worth, TX
Click here to add this to my saved trials
207
mi
from 91732
Fresno, CA
Click here to add this to my saved trials
25
mi
from 91732
Harbor City, CA
Click here to add this to my saved trials
17
mi
from 91732
Hawaiian Gardens, CA
Click here to add this to my saved trials
1724
mi
from 91732
Hazel Crest, IL
Click here to add this to my saved trials
2315
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
43
mi
from 91732
Lancaster, CA
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
1931
mi
from 91732
Maumee, OH
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
?
mi
from 91732
Miami Lakes, FL
Click here to add this to my saved trials
2876
mi
from 91732
Moncton,
Click here to add this to my saved trials
18
mi
from 91732
Montclair, CA
Click here to add this to my saved trials
1655
mi
from 91732
New Orleans, LA
Click here to add this to my saved trials
2336
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
822
mi
from 91732
Northglenn, CO
Click here to add this to my saved trials
919
mi
from 91732
Odessa, TX
Click here to add this to my saved trials
15
mi
from 91732
Pomona, CA
Click here to add this to my saved trials
570
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
1753
mi
from 91732
Saraland, AL
Click here to add this to my saved trials
Spring Valley, California 91978
109
mi
from 91732
Spring Valley, CA
Click here to add this to my saved trials
1347
mi
from 91732
Sugar Land, TX
Click here to add this to my saved trials
367
mi
from 91732
Vallejo, CA
Click here to add this to my saved trials
1219
mi
from 91732
Waco, TX
Click here to add this to my saved trials
2479
mi
from 91732
Waterbury, CT
Click here to add this to my saved trials
West Columbia, South Carolina 29169
2103
mi
from 91732
West Columbia, SC
Click here to add this to my saved trials
814
mi
from 91732
Wheat Ridge, CO
Click here to add this to my saved trials
1580
mi
from 91732
Zachary, LA
Click here to add this to my saved trials