Clinical trial NCT02769481: Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Theracos
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of bexagliflozin compared to glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

Detailed description: Approximately 420 subjects with inadequately controlled T2DM on metformin will be recruited from North America and Europe. Subjects will be randomly assigned to receive bexagliflozin tablets, 20 mg, or glimepiride capsules, 2, 4 or 6 mg, in a ratio of 1:1 once daily for 96 weeks. Subjects will continue to take metformin for the duration of the study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of T2DM
* Currently taking metformin or taking metformin and one additional oral medication for diabetes
* Body Mass Index (BMI) ≤ 45 kg/m2
* Stable dose of blood pressure or cholesterol medications (if applicable) for at least 30 days

Exclusion Criteria:

* Hypersensitivity or other contraindication to the safe use of sulfonylurea or glimepiride
* Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
* Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs
* History of genitourinary tract infections
* Evidence of abnormal liver function
* Myocardial infarction, stroke or hospitalization for heart failure within 3 months of screening
* Prior kidney transplant or evidence of kidney problems
* Pregnant or nursing

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 60
timeFrame: Baseline and Week 60
Secondary outcomes:
measure: Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2
timeFrame: Baseline and 60 weeks
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg
timeFrame: Baseline and 60 weeks
measure: Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks
timeFrame: During the 96 week treatment period
measure: Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.
timeFrame: Baseline to Week 60
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntington Park
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Carlos
country: United States
facility: Research Site
state: California
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Calabash
country: United States
facility: Research Site
state: North Carolina
city: Morehead City
country: United States
facility: Research Site
state: North Carolina
city: Magnolia
country: United States
facility: Research Site
state: Texas
city: Aschaffenburg
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site 2
city: Hamburg
country: Germany
facility: Research Site 2
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Bochnia
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site 2
city: Lublin
country: Poland
facility: Research Site 2
city: Lublin
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Puławy
country: Poland
facility: Research Site
city: Staszów
country: Poland
facility: Research Site
city: Swarzędz
country: Poland
facility: Research Site
city: Toruń
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Zamość
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Świdnik
country: Poland
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site 2
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site 2
city: Madrid
country: Spain
facility: Research Site 3
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site 2
city: Malaga
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site 2
city: Valencia
country: Spain
facility: Research Site
Study officials:
affiliation: Theracos Sub, LLC
name: J. Paul Lock, MD
role: STUDY_DIRECTOR
References: