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

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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.
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