An 18-week, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin in Comparison with Sitagliptin in combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy alone - ND

Conditions: Treatment in type 2 diabetes
MedDRA version: 9.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disorders

Registration Number: EUCTR2007-006095-11-IT

Lead Sponsor: ASTRAZENECA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1900

Inclusion Criteria

1. Provision of informed consent 2. Diagnosed with type 2 diabetes 3. Men or women who are ≥ 18 years of age at time of consenting upon Visit 1. 4. Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1. 5. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such manner that the risk of pregnancy is minimized. 6. HbA1c >6.5% and ≤10.0%.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. 2. Pregnant or breastfeeding patients. 3. Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes). 4. Previous treatment with any DPP-4 inhibitor. 5. Treatment with thiazolidinedione within 12 weeks prior to Visit 1. 6. Treatment with systemic glucocorticoids other than replacement therapy. Inhaled, local injected and topical use of glucocorticoids is allowed. 7. Treatment with cytochrome P450 3A4 (CYP450 3A4) inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin). 8. Treatment with Human immunodeficiency virus (HIV) treatment/antiviral drugs (delavirdine, indinavir, nelfinavir, ritonavir, saquinavir). 9. Potential allergy to metformin, saxagliptin, sitagliptin, or placebo. 10. Contraindications to therapy as outlined in the saxagliptin IB, metformin package insert, or sitagliptin package insert. 11. Congestive heart failure defined as New York Heart Association (NYHA) class III or IV (see Appendix C) and/or left ventricular ejection fraction of ≤40%. 12. Significant cardiovascular history within the past 6 months upon Visit 1 defined as: myocardial infarction, coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident. 13. History of haemoglobinopathies (sickle cell anaemia or thalassemias, sideroblastic anaemia). 14. History of alcohol abuse or illegal drug abuse within the past 12 months. 15. Involvement in the planning and conduct of the study (applies to both AstraZeneca and Bristol-Myers Squibb staff or staff at the study centre). 16. Previous enrolment or randomization of treatment in the present study. 17. Participation in a clinical study during the last 90 days prior to Visit 1. 18. Donation of blood, plasma or platelets within the past 3 months prior to Visit 1. 19. Any condition where, in the opinion of the investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study. 20. Suspected or confirmed poor protocol or medication compliance as judged by the investigator.