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Clinical Trials/EUCTR2010-021069-63-LT
EUCTR2010-021069-63-LT
Active, not recruiting
Phase 1

A randomized, placebo, controlled clinical trial to evaluate cardiovascular outcomes after treatment with Exenatide Once Weekly in patients with type 2 diabetes mellitus - EXenatide Study of Cardiovascular Event Lowering Trial (EXSCEL)

Amylin Pharmaceuticals, LLC0 sites14,000 target enrollmentJanuary 12, 2011
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DrugsBYDUREON 2mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Amylin Pharmaceuticals, LLC
Enrollment
14000
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 12, 2011
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Amylin Pharmaceuticals, LLC

Eligibility 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 \= 7\.0 % 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

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
A Study to Test the Effects of Exenatide Once Weekly on Cardiovascular Outcomes in Patients with Type 2 DiabetesType 2 diabetes mellitusMedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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A Study to Test the Effects of Exenatide Once Weekly on Cardiovascular Outcomes in Patients with Type 2 DiabetesType 2 diabetes mellitusMedDRA version: 19.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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A Study to Test the Effects of Exenatide Once Weekly on Cardiovascular Outcomes in Patients with Type 2 Diabetes.Type 2 diabetes mellitusMedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2010-021069-63-GBAmylin Pharmaceuticals, LCC14,752