A single-center, single-blind study to investigate skin response to sub-therapeutic doses of taspoglutide in GLP-1 analogue naive healthy volunteers

The drug to be given, taspoglutide, is a new, investigational compound that may
eventually be used for the treatment of diabetes mellitus type 2. The study
drug is still in the development phase. Current therapies for diabetes mellitus
type 2 are often inefficient in controlling glucose levels because they have an
effect on only one or a few of the underlying defects. In addition, some of the
antidiabetic medications are associated with undesirable side-effects.
Moreover, some medications can not be used in some patients or require specific
monitoring. Thus, there is a need for new antidiabetic therapies that are both
more effective and better tolerated than currently available antidiabetic
medications.
Taspoglutide is a novel compound, similar to a hormone in the body that is
involved in regulating blood glucose levels. Previous studies with taspoglutide
in patients with diabetes mellitus type 2 have already shown a sustained effect
on lowering blood glucose levels. However, the formulation used until now did
cause allergic and cutaneous reactions in some patients. In order to assess
whether the observed allergic reactions were caused by the taspoglutide itself
or some other component, additional skin tests will be performed in patients
who previously experienced any allergic reaction. The purpose of this study is
to generate skin test data in healthy subjects (never exposed to taspoglutide
or any product with a similar mechanism of action) who will serve as a control
group for patients* skin test study and will allow the valid interpretation of
the test results. The skin prick test and intradermal test (an injection in the
skin with a small amount of test substances) are established methods to
investigate the potential of a compound to cause an allergic reaction as
observed in previous studies. During the skin test procedures different batches
of the formulation of taspoglutide used in patient studies, an extra pure
taspoglutide, all in amounts that are not therapeutic, and placebo (a
formulation without any active ingredient) will be tested. In addition,
histamine (positive control) and a solution without active substance (negative
control) will be used for reference. Everyone is expected to react to histamine
and no reaction is expected from the negative control.

The purpose of the study is to confirm the skin test results in patients based
on results of the control population of healthy volunteers never exposed to
taspoglutide or any product with a similar mechanism of action.

a single-center, single-blind, placebo controlled, skin testing study in six
healthy volunteers to generate control group results in GLP-1 naïve healthy
volunteers for validation of the patient skin test results (skin prick and
intradermal test) for EP (extra pure) taspoglutide, taspoglutide used in Phase
3 studies and placebo relative to positive (histamine) and negative (buffered
saline) controls

Taspoglutide skin pricks, taspoglutide intradermal injections, positive and
negative controls

Procedures: pain. Possible allergic reaction.