Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: 75 mg LX4211; 200 mg LX4211; 400 mg LX4211; 200 mg LX4211; Placebo
Intervention description: Subjects will receive 75 mg LX4211 once daily; Subjects will receive 200 mg LX4211 once daily.; Subjects will receive 400 mg LX4211 once daily.; Subjects will receive 200 mg LX4211 twice daily.; Subjects will receive placebo once daily.
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 299.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes mellitus

Summary:

      This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in
      combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate
      glycemic control on metformin monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects between the ages of 18 to 75 years, inclusive

          -  Confirmed diagnosis of Type 2 diabetes mellitus

          -  Meet required laboratory values at screening, including fasting plasma glucose less
             than 270 mg/dL

          -  Stable dose of metformin monotherapy greater than 1500 mg/day for at least 8 weeks

          -  Willing and able to provide written informed consent

          -  Willing and able to maintain consistent dietary, physical activity, and sleeping
             patterns throughout the study

        Exclusion Criteria:

          -  History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic
             syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes

          -  History of renal disease or clinically significant abnormal kidney function tests

          -  Presence of active hepatic disease or clinically significant abnormal liver function
             tests

          -  Subjects with a history of heart attack, severe/unstable angina, or coronary
             revascularization procedure within 6 months prior to study Day 1

          -  History of clinically significant cardiac arrhythmias within one year of study Day 1

          -  Subjects with congestive heart failure

          -  Subjects with uncontrolled Stage III hypertension

          -  Triglycerides >1000 mg/dL at Screening

          -  Known history of HIV or hepatitis C

          -  History of illicit drug or alcohol abuse with one year of study Day 1

          -  Have had 2 or more emergency room visits, doctor visits, or hospitalizations due to
             hypoglycemia within 6 months of study Day 1

          -  Use of any other investigational drug within 30 days of study Day 1

          -  Prior exposure to LX4211

          -  Use of any medication or herbal supplement for the purpose of weight loss

          -  Chronic use of any antidiabetic therapy other than metformin in the 3 months prior to
             study Day 1

          -  Use of corticosteroids within 2 weeks prior to study Day 1

          -  Major surgery within 6 months of study Day 1

          -  Subjects with any history of severe gastroparesis

          -  Inability or difficulty swallowing whole capsules or tablets

          -  Women who are pregnant or breast feeding