A Study to Test the Effects of Exenatide Once Weekly on Cardiovascular Outcomes in Patients with Type 2 Diabetes

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-021069-63-SK
• Lead Sponsor: Amylin Pharmaceuticals, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-28
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14000

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

- 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 <30 mL/min/1.73 m2.
- Patient has a history of gastroparesis.
- Personal or family history of medullary thyroid cancer or MEN2 (Multiple Endocrine Neoplasia Type 2) or calcitonin level > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified