Clinical trial NCT01611363 (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: asp1941, placebo
SMILES: OC[C@H]1O[C@H]([C@H](O)[C@@H](O)[C@@H]1O)C1=CC=C(F)C(CC2=CC3=CC=CC=C3S2)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

        Inclusion Part A: Healthy subjects

          -  Subject is healthy without diabetes mellitus

          -  Subject has a fasted plasma glucose (FPG) of less than 5.6 mmol/l at screening

          -  Subject has a Body Mass Index (BMI) more than or equal to 18.5 and less than 28.0
             kg/m2

          -  Subject's serum creatinine is within the normal range

        Inclusion Part A: T2DM subjects

          -  Subject has been diagnosed with T2DM for at least 6 months

          -  Subject's body mass index (BMI) is equal to or more than 20.0 and less than 35.0 kg/m2
             at screening

          -  Subject has a HbA1c level above 7.0% and less than 9.0% at screening

          -  Subject has a (FPG) of less than 10.0 mmol/l

          -  Subject is treatment naïve to glucose-lowering medication or uses metformin that will
             be washed out at least 3 weeks prior to the first dosing at Day 1

          -  Subject's serum creatinine is within the normal range

        Inclusion Part B: T2DM subjects

          -  Subject has a body mass index (BMI) of more than or equal to 20.0 and less than 35.0
             kg/m2 at screening.

          -  Subject has been diagnosed with T2DM for at least 6 months

          -  Subject has HbA1c level of equal to or more than 6.0% and less than 10% at screening

          -  Subject has a FPG of less than 10.0 mmol/l

          -  Subject is drug naïve or on a stable glucose lowering therapy (metformin, TZD, DPP-4
             inhibitor or SUD therapy

        Exclusion Criteria:

        Exclusion Part A: Healthy subjects

          -  Any of the liver function tests above the upper limit of normal

          -  A QTc interval of >430 ms (males) and >450 ms (females), a history of unexplained
             syncope, cardiac arrest, unexplained significant cardiac arrhythmias or torsades de
             pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

          -  Abnormal pulse and/or blood pressure measurements at screening as follows: Pulse <40
             or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90
             mmHg

          -  eGFR (based on Modification of Diet in Renal Disease (MDRD) method) less than 60
             ml/min/1.73m2 on Day -2

        Exclusion Part A & Part B: T2DM subjects

          -  Subject has type 1 diabetes mellitus

          -  A QTc interval of >450 ms (males) and >470 ms (females), a history of unexplained
             syncope, cardiac arrest, unexplained significant cardiac arrhythmias or torsades de
             pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

          -  Subject is on an insulin therapy or has received insulin within 3 months prior to
             screening, with the exception of acute use of <7 days prior to screening

          -  Subject has a urinary microalbumin/creatinine ratio above or equal to 300 mg/g at
             screening

          -  Subject has an ALT and/or AST higher than 3 times the upper limit of normal or has a
             total bilirubin more than 2 times the upper limit of normal at screening

          -  Subject has a symptomatic urinary tract infection or symptomatic genito-urinary
             infection at screening

          -  Subject has persistent, uncontrolled severe hypertension as indicated by a mean
             systolic blood pressure > 160 mmHg or a mean diastolic blood pressure of > 100 mmHg

          -  Subject has significant cardiovascular disease

          -  eGFR (based on MDRD method) less than 60 ml/min/1.73m2 on Day -2