Non-insulin dependent type 2 diabetes mellitus in elderly patients (= 65 years) MedDRA version: 14.0 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 =9.0%. 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study will be to show the superiority of saxagliptin compared to glimepiride in bringing elderly patients (=65 years) with type 2 diabetes to HbA1c target <7% without hypoglycaemia (confirmed or severe) over a 52-week treatment period. Saxagliptin or glimepiride will be administered as an add-on therapy to a background therapy with metformin.;Primary end point(s): The primary endpoint is the proportion of patients reaching HbA1c target <7% without hypoglycaemia (confirmed or severe) over a 52-week treatment period.;Secondary Objective: To compare the effects of saxagliptin versus glimepiride given as add-on to a metformin therapy after 52 weeks of a double-blind treatment period by evaluation of secondary efficacy and safety endpoints described below: Key secondary (safety analysis) - Proportion of patients having experienced at least one hypoglycaemic event (confirmed or severe) over the 52-week double-blind treatment period Efficacy - Change from baseline to Week 52 in HbA1c - Proportion of patients achieving a therapeutic glycaemic response at Week 52 defined as HbA1c <7.0% or <6.5% - Change from baseline to Week 52 in fasting plasma glucose (FPG) and insulin - Change from baseline to Week 52 in ß-cell function (as measured by Homeostasis Model Assessment-ß [HOMA-ß] | — |
Countries
Austria, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Norway, Spain, Sweden, United Kingdom
Outcome results
None listed