Ensayo clínico fase IIIb/IV multicéntrico, aleatorizado, doble ciego, con control activo, de 24 semanas de duración, para evaluar la eficacia y tolerabilidad de añadir saxagliptina comparado con titular al alza la dosis de metformina en pacientes con diabetes tipo 2 y un control glucémico inadecuado en tratamiento con metformina en dosis sub-máximas.A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-on Compared to Uptitration of Metformin in Patients with Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin - Prompt

Conditions: Diabetes mellitus tipo 2 no insulino dependienteNon-insulin dependent type 2 diabetes mellitus
MedDRA version: 9.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitus

Registration Number: EUCTR2009-012775-10-ES

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 268

Inclusion Criteria

1.Provision of informed consent prior to any study specific procedures.
2.Men or women who are >/=18 years of age at time of consenting upon Visit 1.
3.Clinical diagnosis of type 2 diabetes.
4.Treatment with metformin alone (any formulation) on stable doses of 1500 to 1700 mg 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 a manner that the risk of pregnancy is minimized.
- WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >/=12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level >35 mIU/mL).
- Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (eg, vasectomy), should be considered to be of childbearing potential.
6.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) 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

1.Any clinically significant abnormality identified on physical examination or laboratory tests that would compromise patient?s safety or successful participation in the study as judged by the investigator.
2.Patients who have previously been intolerant to or non-compliant with a total daily dose of metformin higher than 1500 to 1700 mg.
3.Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
4.Pregnant or breastfeeding patients.
5.Prior use of insulin or injectable GLP-1 analogue (exenatide or liraglutide) within 3 months of the study start.
6.Treatment with systemic glucocorticoids other than replacement therapy. Inhaled, local injected and topical use of glucocorticoids are allowed.
7.Treatment with cytochrome P450 3A4 (CYP450 3A4) inducers, eg, carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin and St. John?s Worth, and cytochrome P450 3A4/5 (CYP450 3A4/5) inhibitors, eg, delavirdine, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole (topical use is allowed), nefazodone, saquinavir and telithromycin.
8.Potential allergy to saxagliptin, placebo or formulation excipients.
9.Past hypersensitivity reaction to a DPP-4 inhibitor.
10.Contraindications to therapy as outlined in the saxagliptin Investigator?s Brochure.
11.Contraindications to therapy as outlined in the metformin package insert including conditions leading to an increased risk of hypoxemia and lactic acidosis.
12.History of haemoglobinopathies (sickle cell anaemia or thalassemias, sideroblastic anaemia).
13.History of alcohol abuse or illegal drug abuse within the past 12 months.
14.Involvement in the planning and conduct of the study (applies to both AstraZeneca and Bristol-Myers Squibb personnel or personnel at the study centre).
15.Participation in a clinical study during the past 3 months prior to Visit 1.
16.Donation of blood, plasma or platelets within the past 3 months prior to Visit 1.
17.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.
18.Suspected or confirmed poor protocol or medication compliance as judged by the investigator.
Additional Exclusion criteria at Visit 2:
19.Serum creatinine >/=133 μmol/L (>/=1.5 mg/dL) for men or >/=124 μmol/L (>/=1.4 mg/dL) for women.
20.Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3xULN and/or total bilirubin >34 μmol/L (>2.0 mg/dL).
21.Creatine kinase (CK) >/=10xULN.