None listed
Conditions
Interventions
ELIGIBLE PATIENTS WILL HAVE TYPE 2 DIABETES WITH A GLYCATED HEMOGLOBIN (HbA1c) ≥
10.0% ON STABLE DOSES OF UP TO THREE (ie., 0-3) ORAL HYPOGLYCEMIC AGENTS (AHAs) FOR AT LEAST 3 MONTHS, i.e NO ORAL AHA ADJUSTMENTS IN THE PAST 3 MONTHS. PATIENTS ENROLLED WILL BE AT A WIDE RANGE OF CV
Sponsors
ELI LILLY AND COMPANY, Amylin Pharmaceuticals Inc.,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: A. PATIENT HAVE TYPE 2 DIABETES MELLITUS B. PATIENT WILL ABLE TO SEE A USUAL CARE PROVIDER AT LEAST TWICE A YEAR. C. PATIENT HAS AN HbA1c OF ≥ 7.0% AND ≤ 10.0% STABLE DOSES OF UP TO THREE (ie., 0-3) ORAL AHAS FOR AT LEAST 3 MONTHS i.e. NO ORAL AHA ADJUSTMENTS IN THE PAST 3 MONTHS. CONCOMITANT USE OF DPP-4 INHIBITORS IS PERMITTED. HbA1c VALUES MUST BE FROM WITHIN 3 MONTHS PRIOR TO RANDOMIZATION. IF MULTIPLE VALUES ARE AVAILABLE, THE MOST RECENT REPORTED VALUE SHOULD BE USED. A PATIENTS WHOSE VALUE IS > 10.0% MAY, ON THE DISCRETION OF THE INVESTIGATOR, HAVE THEIR ORAL AHA THERAPY ADJUSTED AND BE RE-SCREENED ONCE FOR HbA1c RANDOMIZATION ELIGIBILITY (≥ 7.0% AND ≤ 10.0%) FOLLOWING A 3 MONTHS PERIOD ON STABLE AHA DOSES. D. PATIENTS WITH ANY LEVEL OF CV RISK AND METTING ALL OTHER INCLUSION CRITERIA MAY BE ENROLLED. RECRUITMENT WILL BE CONSTRAINED SUCH THAT APPROXIMATELY 40 % WILL NOT HAVE HAD A PRIOR CV EVENT AND 60 % WILL HAVE HAD A PRIOR CV EVENT DEFINED AS AT LEAST ONE OF THE FOLLOWING: • HISTORY OF A MAJOR CLINICAL MANIFESTATION OF CORONARY ARTERY DISEASE i.e. MYOCARDIAL INFARCTION, SURGICAL OR PERCUTANEOUS (BALLOON AND/OR STENT) CORONARY REVASCULARIZATION PROCEDURE, OR CORONARY ANGIOGRAPHY SHOWING AT LEAST ONE STENOSIS ≥ 50% IN A MAJOR EPICARDIAL ARTERY OR BRANCH VESSEL.
Exclusion criteria
Exclusion criteria: A. PATIENT HAS A DIAGNOSIS OF TYPE 1 DIABETES MELLITUS, OR A HISTORY OF KETOACIDOSIS. B. PATIENT HAS TAKEN INSULIN WITHIN 2 WEEKS OF SCREENING VISIT OR FOR GREATER THAN 1 WEEK WITHIN 3 MONTHS OF SCREENING VISIT. C. PATIENT HAS EVER BEEN TREATED WITH AN APPROVED OR INVESTIGACIONAL GLP-1 RECEPTOR AGONIST e.g. BYETTA (EXENATIDE), EQW, VICTOZA (LIRAGLUTIDE), OR TASPOGLUTIDE. D. PATIENT IS ENROLLED IN ANOTHER EXPERIMENTAL PROTOCOL WHICH INVOLVES THE USE OF AN INVESTIGATIONAL DRUG OR DEVICE, OR AN INTERVENTION THAT WOULD INTERFERE WITH THE CONDUCT OF THE TRIAL. E. PATIENT HAS A PLANNED OR ANTICIPATED REVASCULARIZATION PROCEDURE. F. PREGNANCY OR PLANNED PREGNANCY DURING THE TRIAL PERIOD. G. PATIENT HAS MEDICAL HISTORY THAT INDICATES A LIFE EXPECTANCY OF < 2 YEARS OR MIGHT LIMIT THE INDIVIDUAL´S ABILITY TO TAKE TRIAL TREATMENTS FOR THE DURATION OF THE TRIAL. H. PATIENT HAS A HISTORY OR CURRENT EVIDENCE OF ANY CONDITION, THERAPY, LABORATORY ABNORMALITY, OR OTHER CIRCUNSTANCE WHICH, IN THE OPINION OF THE INVESTIGATOR OR COORDINATOR, MIGHT POSE AN UNACCEPTABLE RISK TO THE PATIENT, CONFOUND THE RESULTS OF THE TRIAL eg., IF PATIENT CANNOT COMPLY WITH REQUIREMENTS OF THE TRIAL, OR LIKELY TO INTERFERE WITH THE PATIENT´S PARTICIPATION FOR THE FULL DURATION OF THE TRIAL.
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Korea North, Lithuania, Malasya, Mexico, New Zealand, Philippines, Poland, Romania, Russian Federation, Slovakia, Taiwan, Ukraine, United Kindgdom, United States
Contacts
Public ContactYNGRID ROSSANA SALDARRIAGA
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed