Type 2 diabetes mellitus MedDRA version: 19.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: BYDUREON 2mg
Product Name: Exenatide
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Exenatide
CAS Number: 141732-76-5
Concentration unit: mg mill
Sponsors
Amylin Pharmaceuticals, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient has type 2 diabetes mellitus - Patient will able to see a usual care provider at least twice a year - Patient has an HbA1c of = 6.5% and = 10.0% and is currently using one of the following treatment regimens: •Treatment with up to three (i.e., 0-3) oral AHAs (concomitant use of DPP-4 inhibitors is permitted). •Insulin therapy, either alone or in combination with up to two (ie., 0-2) oral AHAs (use of basal and prandial insulins is permitted in any combination of individual or premixed insulins) All patients should be on a stable diabetes management regimen, as assessed by the investigator, at the time of enrollment. - Patients with any level of CV risk. - Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant. - Patient agrees to provide permission to obtain all medical records necessary for complete data ascertainment during the follow-up period, and agrees to communication between the trial site and the usual care provider in order to facilitate routine care. - Patient is 18 years or older at enrollment. 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 10500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3500
Exclusion criteria
Exclusion criteria: - Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis. - Patient has a history (= 2 episodes) of severe hypoglycemia within 12 months of enrollment. - Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. exenatide BID, exenatide once weekly, liraglutide, lixisenatide, albiglutide, taspoglutide, or dulaglutide. - 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. - Patient has a planned or anticipated revascularization procedure. - Pregnancy or planned pregnancy during the trial period. - Patient has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient, confound the results of the trial e.g. 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. - Patient has end-stage renal disease or an estimated glomerular filtration rate of 40ng/L at baseline. - Patient has previously been enrolled in EXSCEL. - Patient has a history of pancreatitis. - Is an employee of Amylin Pharmaceuticals LLC, Bristol-Myers-Squibb Company or AstraZeneca.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of EXSCEL will be to evaluate the effect of exenatide once weekly (EQW), used in addition to the current usual care for glycemic control, on major macrovascular events when administered to patients with type 2 diabetes.;Secondary Objective: The secondary objectives of EXSCEL are to evaluate the effect of EQW treatment used in addition to the current usual care for glycemic control on: (1) All cause mortality (2) Each of the components of the primary composite CV endpoint (3) Hospitalization for acute coronary syndrome (ACS) (4) Hospitalization for congestive heart failure (CHF);Primary end point(s): Primary Efficacy Endpoint: Time to first confirmed CV event in the primary composite CV endpoint. Defined as the time from randomization to first confirmed CV-related death, nonfatal MI or nonfatal stroke. ;Timepoint(s) of evaluation of this end point: 1360 patients with positively adjudicated primary endpoint events have been accrued | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: - Time to all-cause mortality. Defined as time from randomization to death due to any cause. - Time to first confirmed CV event for each component of the primary composite endpoint. - Time to hospitalization for acute coronary syndrome. - Time to hospitalization for heart failure. ;Timepoint(s) of evaluation of this end point: 1360 patients with positively adjudicated primary endpoint events have been accrued | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Germany, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactProject Leader
PAREXEL International
Outcome results
None listed