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Clinical Trials/EUCTR2015-001760-19-NL
EUCTR2015-001760-19-NL
Active, not recruiting
Phase 1

A double blind placebo controlled study to evaluate the effects of bexagliflozin on hemoglobin A1c in patients with type 2 diabetes and increased risk of cardiovascular adverse events

Theracos Sub, LLC0 sites1,650 target enrollmentDecember 22, 2015
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ConditionsType II diabetesMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Type II diabetes
Sponsor
Theracos Sub, LLC
Enrollment
1650
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 22, 2015
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Theracos Sub, LLC

Eligibility Criteria

Inclusion Criteria

  • •The study population will include:
  • •1\. Male or female adult subjects with an age \=40 years
  • •2\. Subjects with a diagnosis of T2DM
  • •3\. Subjects with HbA1c values of 7\.0 – 11%, inclusive
  • •4\. Subjects with fasting plasma glucose (FPG) \= 300 mg/dL at screening
  • •5\. Subjects who have a regimen for treatment of T2DM that has been stable for the past 3 months. A stable regimen is defined as: no changes in dose or frequency of OHAs or GLP\-1 agonists, or \< 20% variability in total daily insulin dose.
  • •6\. Subjects who present with at least one of the following 3 histories:
  • •Group 1: A history of atherosclerotic vascular disease as defined by one or more of the following:
  • •a) myocardial infarction (MI) or ischemic (non\-hemorrhagic) stroke
  • •\> 3 months but \= 5 years prior to screening or

Exclusion Criteria

  • •Patients who exhibit any of the following characteristics will be excluded from the study.
  • •1\. Diagnosis of type 1 diabetes mellitus or maturity–onset/diabetes of the young (MODY)
  • •2\. Hemoglobinopathy that affects HbA1c measurement
  • •3\. Frequent symptomatic hypoglycemia (greater than one episode per week on average)
  • •4\. Genitourinary tract infection within 6 weeks of screening or history of \= 3 genitourinary infections requiring treatment within the last 6 months
  • •5\. Cancer, active or in remission for \< 3 years (Non\-melanoma skin cancer or basal cell carcinoma or carcinoma in situ of the cervix will not be grounds for exclusion)
  • •6\. History of alcohol or illicit drug abuse in the past 2 years
  • •7\. Evidence of abnormal liver function tests (total bilirubin or alkaline phosphatase \> 1\.5 x upper limit of normal (ULN) with the exception of isolated Gilbert’s syndrome); or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2\.5 x ULN
  • •8\. History of MI, stroke or hospitalization for heart failure in the prior 3 months
  • •9\. Evidence of NYHA class IV heart failure at screening or randomization

Outcomes

Primary Outcomes

Not specified

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