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

Study identifier:D1683C00005

ClinicalTrials.gov identifier:NCT02681094

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

Study drug

Dapagliflozin, Placebo for Dapagliflozin, Saxagliptin, Placebo for Saxagliptin

Sex

All

Actual Enrollment

905

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 26 Feb 2016

Primary Completion Date: 15 Jul 2017

Study Completion Date: 15 Jul 2017

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2018 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
Active Comparator: Saxagliptin+Dapagliflozin+Metformin 5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin	Drug: Dapagliflozin 5mg, orally, Green, plain, diamond-shaped, film-coated tablet Other Name: Forxiga Drug: Saxagliptin 5mg, orally, Plain, yellow, biconvex, round, film-coated tablet Other Name: Onglyza™
Active Comparator: Dapagliflozin+Saxagliptin placebo+Metformin 5 mg Tablets, Oral, Once daily, 24 weeks for Dapagliflozin and Saxagliptin Placebo	Drug: Dapagliflozin 5mg, orally, Green, plain, diamond-shaped, film-coated tablet Other Name: Forxiga Drug: Placebo for Saxagliptin Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet
Active Comparator: Saxagliptin+Dapagliflozin placebo+metformin 5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin placebo	Drug: Placebo for Dapagliflozin Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet Drug: Saxagliptin 5mg, orally, Plain, yellow, biconvex, round, film-coated tablet Other Name: Onglyza™

Documents available

d1683c00005 csp Redacted
Download
D1683C00005 SAP redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]