A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with exenatide once weekly in Patients with Type 2 Diabetes Mellitus” (EXSCEL: EXenatide Study of Cardiovascular Event Lowering Trial) - EXSCE

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2010-021069-63-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-02
• Study Completion: 2017-04-24
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14752

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 = 7.0 % and = 10.0% on stable doses of up to three (i.e. 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 inhinbitors is permitted. - 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?
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis. - Patient has taken insulin within 2 weeks of screening visit or for greater than 1 week within 3 months of screening visit. - Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA (exenatide), EQW, VICTOZA (liraglutide), or taspoglutide. - 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 Multiple Endocrine Neoplasia Type 2 or calcitonin level of 100 ng/L or greater. - Patient has a history of pancreatitis.

Study & Design

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