Non-insulin dependent type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of informed consent Diagnosed with type 2 diabetes Man or women equal to or above 18 years of age Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks Women of childbearing potential must be using an adequate method of contraception. HbA1c above 6.5% and below or equal to 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
Exclusion criteria: Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. Pregnant of breastfeeding patients Insulin therapy within 1 year Previous treatment with any DPP-4 inhibitor Treatment with thiazolidinedione within 12 weeks Treatment with systemic glucocorticoids other than replacement therapy, CYP460 3A4 inducers and/or HIV treatment/antiviral drugs Potential allergy to metformin, saxagliptin, sitagliptin, or placebo Contraindications to therapy as outlined in the saxagliptin IB, metformin package insert or sitagliptin package insert Congestive heart failure defined as NYHA class III or IV and/or left ventricular ejection fraction equal to or below 40% Significant cardiovascular history within the 6 past months History of haemoglobinopathies, alcohol abuse or illegal drug abuse Involvement in the planning and conduct of the study Previous enrolment or randomization of treatment in the present study Participation in a clinical study during the last 90 days Donation of blood, plasma or platelets within the past 3 months 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 Suspected or confirmed poor protocol or medication compliance as judged by the investigator Serum creatinine equal to or above 133 micromol/L, for men and 124 micromol/L for women Active liver disease and/or significant abnormal liver function Creatinine kinase equal or above 3xULN History of positive serologic evidence of current infectious liver disease Any clinically significant abnormality identified on physical examination or laboratory tests or ECG, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare that, after 18 weeks of oral administration of double-blind treatment, the change from baseline in HbA1c achieved with saxagliptin 5 mg per day added onto metformin is non-inferior to sitagliptin 100 mg per day added onto metformin in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg or higher doses of metformin therapy alone.;Secondary Objective: Efficacy: To compare the effects of saxagliptin 5 mg per day versus sitalgiptin 100 mg per day given as add on therapy to metformin after 18 weeks of double-blind treatment period by evaluation of markers of diabetes progression including fasting plasma glucose, insulin, C-peptide, glucagon and proinsulin. Safety: Safety and tolerability will be evaluated by assessment of AEs, laboratory values, ECG, pulse, blood pressure, body weight and physical examination. ;Primary end point(s): The primary outcome variable is the change in HbA1c from baseline to Week 18 in the double-blind phase achieved with saxagliptin 5 mg per day versus sitagliptin 100 mg per day both added onto metformin. | — |
Countries
Denmark, France, Italy, Sweden
Outcome results
None listed