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

Phase 1

• Conditions: Type 2 diabetes mellitus, inadequate glycaemic control; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005406-11-DE
• Lead Sponsor: Astrazeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-25
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. Patients aged =18 years old at time of informed consent;
2. Patients with 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 783
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 117

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 ALT and/or AST =3x ULN 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 IgM, Hepatitis B surface antigen, and Hepatitis C virus antibody.
6.Moderate or severe impairment of renal function [defined as eGFR <60mL/min/1.73 m2 (estimated by 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified