An open-label, randomized crossover study to evaluate the effect of ASP1941 on the pharmacokinetics, pharmacodynamics, safety and tolerability of glimepiride in healthy subjects and vice versa.

The drug to be given is a new, investigational compound that may eventually be
used for the treatment of Diabetes Mellitus Type 2 (T2DM). T2DM is
characterized by repeatedly increased blood glucose levels. Consequences may be
that patients with T2DM are often thirsty, urinate a lot, and may have
complications affecting the peripheral nerves (tingling and insensitivity in
hands and feet), the blood vessels (atherosclerosis), the eyes (disease of the
retina) and the kidneys (kidney failure). The new compound might help to
control blood glucose levels. This new compound is still under development and
as a result has not been registered as a drug.
The main objective of this study is to evaluate the effect when the new
compound is taken in combination with glimepiride. Glimepiride is a registered
drug that lowers the blood glucose level and is licensed as treatment for type
2 diabetes when diet and exercise changes alone have not been successful.

For Part A: the purpose of this part is to investigate the effect of multiple
oral doses of the new study drug on how quickly and to what extent glimepiride
is absorbed and eliminated from the body (this is called pharmacokinetics), if
glimepiride is given as a single dose. In addition, the effect of multiple oral
doses of the new study drug on the safety and tolerability of a single dose of
glimepiride will be investigated.

For Part B: the purpose of this part is to investigate the effect of multiple
oral doses of glimepiride on how quickly and to what extent teh study drug is
absorbed and eliminated from the body (this is called pharmacokinetics), if the
new study drug is given as a single dose. In addition, the effect of multiple
oral doses of glimepiride on the safety and tolerability of a single dose of
the new study drug will be investigated.
Also, it will be investigated if multiple oral doses of glimepiride influence
the effects on the body (this is called pharmacodynamics) of the study drug.

Part A+B
This part will be of an open-label, randomized two-sequence design.

Part A
Treatment 1: an oral dose of glimepiride on Days 1 and 8 and an oral dose of
study drug once daily on Days 4-10
Treatment 2: an oral dose of glimepiride on Days 5 and 10 and an oral dose of
study drug once daily on Days 1-7

Part B
Treatment 3: an oral dose of study drug on Days 1 and 6 and an oral dose of
glimepiride once daily on Days 4-8
Treatment 4: an oral dose of study drug on Days 3 and 8 and an oral dose of
glimepiride once daily on Days 1-5

Procedures: pain, light bleeding heamatoma, possibly an infection.

Study drug: well tolerated medication with adverse events that were of mild
intensity and short duration. More frequent reported adverse effects were
headache, constipation, and frequent urination.

Glimepiride is a registered anti-diabetic drug, like all medicines, glimepiride
can cause side effects although not everybody gets them. For glimepiride used
in the patient population, the most commonly reported side effects are allergic
reactions (including inflammation of blood vessels, often with skin rash),
abnormal liver function including yellowing of the skin and eyes (jaundice),
problems with the bile flow (cholestasis), inflammation of the liver
(hepatitis) or liver failure, allergy (hypersensitivity) of the skin such as
itching, rash, hives and increased sensitivity to sun and severe hypoglycemia
including loss of consciousness, seizures or coma.