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Clinical Trials/NL-OMON47856
NL-OMON47856
Completed
Phase 3

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 study THR-1442-C-476

Theracos Sub, LLC0 sites132 target enrollmentTBD
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ConditionsType 2 diabetes and increased risk of cardiovascular adverse events100192801001842410003216

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Type 2 diabetes and increased risk of cardiovascular adverse events
Sponsor
Theracos Sub, LLC
Enrollment
132
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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\.5 \* 11%, inclusive
  • •4\. Subjects with fasting plasma glucose (FPG) \* 250 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
  • •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

Exclusion Criteria

  • •Patients who exhibit any of the following characteristics will be excluded from
  • •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
  • •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
  • •6\. History of alcohol or illicit drug abuse in the past 2 years

Outcomes

Primary Outcomes

Not specified

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