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Clinical Trials/EUCTR2016-002013-21-PL
EUCTR2016-002013-21-PLActive, not recruitingPhase 1

A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin versus Glimepiride in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin

Theracos Sub, LLC0 sites701 target enrollmentStarted: November 25, 2016Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
701
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •1. Male or female adult subjects = 18 years of age
  • •2. If subjects are female of childbearing potential, subjects must be negative on the urine pregnancy test and agree to abstain from coitus or use contraception during the entire study to avoid any possible pregnancy
  • •3. Subjects who are in one of the two categories:
  • •a. Metformin-only treated: receive = 1500 mg/day metformin only for at least 8 weeks prior to screening (subjects who have received < 14 days of any antidiabetic medications besides metformin in the 8 weeks prior to screening are allowed) or
  • •b. Metformin-and-OHA treated: receive = 1500 mg/day metformin for at least 8 weeks
  • •prior to screening and = 14 days of 1 additional oral hypoglycemia agent (OHA) in the 8 weeks prior to screening. Subjects taking any other antidiabetic medication (in addition to metformin and the 1 OHA) for < 14 days in the 8 weeks prior to screening
  • •are allowed.
  • •4. Subjects with a diagnosis of T2DM with HbA1c levels between 7.0% and 10.5% (inclusive) at screening if metformin-only treated or with HbA1c levels between 6.5% and 10.0% (inclusive) at screening if metformin- and-OHA treated
  • •5. Subjects with a body mass index (BMI) = 45 kg/m2 at Screening
  • •6. If applicable, taking stable doses of treatment for dyslipidemia and/or hypertension for 30 days prior to screening. Subjects do not need to be treated for dyslipidemia or hypertension to be eligible for the study
  • •7. Subjects who are willing and able to return for all clinic visits and to complete all studyrequired procedures, including self-monitoring blood glucose (SMBG) measurements Prior to randomization, all subjects must:
  • •8. Maintain adequate glycemic control during the washout and run-in periods (fasting plasma glucose values are not = 250 mg/dL on consecutive days)
  • •9. Have an HbA1c between 7.0% and 10.5% (inclusive) at Visit V5
  • •10. Adhere to the investigational product administration requirements as evidenced by missing no more than 2 doses of run-in medications
  • •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 325
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

  • •Subjects 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. Current use of injected therapy for treatment of diabetes (insulin or glucagon-like peptide-1 (GLP-1) receptor agonist therapy) or a thiazolidinedione (TZD)
  • •3. Hemoglobinopathy that affects HbA1c measurement
  • •4. Any contraindication to the safe use of sulfonylurea therapy, glimepiride or metformin, including known hypersensitivity reaction
  • •5. Genitourinary tract infection within 6 weeks of screening or history of = 3 genitourinary infections requiring treatment within 6 months from screening
  • •6. 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)
  • •7. History of alcohol or illicit drug abuse in the past 2 years
  • •8. 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
  • •9. Estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), <60 mL/min/1.73 m2 at screening.
  • •10. Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure > 95 mmHg) at Visit V1
  • •11. History of human immunodeficiency virus (HIV) infection
  • •12. Life expectancy < 2 years
  • •13. History of myocardial infarction (MI), unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
  • •14. History of treatment with an investigational drug within 30 days or within 7 half-lives of the investigational drug, whichever is longer
  • •15. Previous treatment with bexagliflozin or EGT0001474 study drug (run-in or double-blind investigational product)
  • •16. Currently or within 3 months of taking any SGLT2
  • •17. Currently participating in another interventional trial
  • •18. Prior renal transplantation or evidence of nephrotic syndrome (defined as a Urine albumin-to-creatinine ratio (UACR) > 1500 mg/g at screening).
  • •19. Any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the primary investigator, would jeopardize the subject’s appropriate participation in this study or obscure the effects of treatment including condition or co-morbidity for which the use of metformin or any planned or existing second diabetes therapy is contraindicated
  • •20. Female subjects who are pregnant or nursing.
  • •21. Two or more consecutive SMBG measures = 250 mg/dL (13.9 mmol/L) prior to randomization or severe clinical signs or symptoms of hyperglycemia prior to randomization, including weight loss, blurred vision, increased thirst, or increased urination, or fatigue

Investigators

Sponsor
Theracos Sub, LLC

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