Clinical trial NCT01441232 (phase 1, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: lx4211, januvia®
SMILES: N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F
Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 18 to 65 years of age

          -  History of Type 2 Diabetes Mellitus for at least 3 months prior to Screening, with
             HgbA1c values of 6.5 to 10.5% and C-peptide ≥1.0 ng/mL

          -  Body mass index (BMI) ≤45 kg/sq m

          -  Willing and able to self-monitor blood glucose

          -  Able to provide written informed consent

        Exclusion Criteria:

          -  History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic
             syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes

          -  Current use of any blood glucose lowering agent other than metformin

          -  History of renal disease or clinically significant abnormal kidney function tests at
             Screening or Day -2

          -  Presence of active hepatic disease or clinically significant abnormal liver function
             tests at Screening or Day -2

          -  History of myocardial infarction, severe/unstable angina, or coronary
             revascularization procedure within 6 months of Day -2

          -  History of clinically significant cardiac arrhythmias within 1 year of Day -2

          -  Congestive heart failure and/or New York Heart Association (NYHA) class III or IV
             symptoms of heart failure

          -  Subjects with uncontrolled Stage 3 hypertension

          -  History of 2 or more emergency room visits, doctor's visits, or hospitalizations due
             to hypoglycemia within 6 months of Day -2

          -  History of alcohol or drug abuse within 12 months of Screening

          -  History of bowel resection > 20 cm, any malabsorptive disorder, severe gastroparesis,
             and GI procedure for the purpose of weight loss that would slow gastric emptying

          -  History of HIV or hepatitis C

          -  Major surgery within 3 months of Day -2 or any planned surgery during the study

          -  History of any active infection within 2 weeks of Day -2

          -  History of pancreatitis

          -  History of any malignancy within the last 5 years which would affect the diagnosis or
             assessment of LX4211 or sitagliptin

          -  History of any serious adverse reaction or hypersensitivity to LX4211 or sitagliptin

          -  Presence of any clinically significant physical, laboratory, or ECG findings or any
             concurrent condition at Screening that may interfere with the study in the opinion of
             the investigator

          -  Triglycerides > 1000 mg/dL at Screening or Day -2

          -  Donation or loss of >400 mL of blood or blood product within 8 weeks prior to Day -2

          -  Use of any tobacco product for the duration of study participation

          -  Use of corticosteroids within 2 weeks of Day 1

          -  Use of digoxin or warfarin within 2 weeks prior to Screening