EUCTR2009-012816-41-ESActive, not recruitingNot Applicable
Ensayo clínico fase IIIb/IV multicéntrico, aleatorizado, doble ciego, con control activo, de 52 semanas de duración, para evaluar la eficacia y tolerabilidad de saxagliptina comparada con glimepirida en pacientes ancianos con diabetes tipo 2 con un control glucémico inadecuado en tratamiento con metfomina en monoterapia.A 52-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy - Generation
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 698
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Provision of informed consent prior to any study specific procedures.
- •2.Established clinical diagnosis of type 2 diabetes.
- •3.Men or women who are >/=65 years of age at time of consenting upon Visit 1.
- •NB: The cohorts will be approximately 60% of the patients for age group 65 to 75 years and 40% for age-group >/=75 years. The enrolment to the cohorts will be stopped when the number of patients is reached.
- •4.Treatment with a stable metformin monotherapy, at any dose, for at least 8 weeks prior to Visit 1.
- •5.HbA1c >/=7.0% and Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •1. Any clinically significant abnormality identified on physical examination, ECG or laboratory tests that would compromise patient?s safety or successful participation in the study as judged by the investigator.
- •2. Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
- •3. Current use of any injectable or oral antihyperglycaemic agent excluding metformin.
- •4. Treatment with any additional oral or injectable antihyperglycaemic agent within 8 weeks prior to Visit 1.
- •5. Renal impairment as defined by a creatinine clearance <60 mL/min (using the Modification of Diet in Renal Disease [MDRD] equation), as well as patients with End Stage Renal Disease (ESRD) on haemodialysis
- •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 and cytochrome P450 3A4/5 (CYP450 3A4/5) inhibitors.
- •8. Past history of intolerance, allergy or hypersensitivity to glimepiride, other sulphonylureas or sulphonamides.
- •9. Past hypersensitivity reaction to a DPP-4 inhibitor.
- •10. Contraindications to therapy as outlined in the saxagliptin IB.
- •11. Contraindications to therapy as outlined in the glimepiride package insert.
- •12. Contraindications to therapy as outlined in the metformin package insert, including conditions leading to an increased risk of hypoxaemia and lactic acidosis.
- •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 AstraZeneca and Bristol-Myers Squibb personnel and study centre personnel).
- •16. Participation in a clinical study during the last 3 months prior to Visit 1.
- •17. Donation of blood, plasma or platelets within 3 months prior to Visit 1.
- •18. Important cognitive function problems.
- •19. Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study.
- •20. Suspected or confirmed poor protocol or medication compliance as judged by the investigator. Additional exclusion criteria at Visit 2:
- •21. Active liver disease and/or significant abnormal liver function
- •22. Creatine kinase (CK) >10xULN
- •23. Any clinically significant abnormality identified on physical examination or laboratory tests, which in the judgement of the investigator would compromise the patient?s safety or successful participation in the clinical study. Additional exclusion criteria at Visit 3:
- •24. Any clinically significant abnormality identified on brief physical examination, which in the judgement of the investigator would compromise the patient safety or successful participation in the clinical study.
Investigators
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