A Multiple-Ascending Dose Study in Type 2 Diabetes Mellitus Patients
A Multiple-Ascending Dose Study in Type 2 Diabetes Mellitus Patients
The study drug LY2393910 is being evaluated as a possible treatment for diabetes. The primary
 purpose of a patient's participation in this study is to help answer the following research
 question(s), and not to provide treatment for diabetes:

 -  The safety of LY2393910 and any side effects that might be associated with it following
 2 weeks of doses

 -  How long it takes the body to absorb and remove LY2393910 following dosing over 2 weeks

 -  How daily dosing of LY2393910 affects blood levels of sugar (glucose), insulin and other
 naturally occurring substances in your body

 -  How daily dosing of LY2393910 affects the cells that produce insulin

 -  Any differences in the above between LY2393910 taken as daily doses in the morning or in
 the evening
Inclusion Criteria:

 -  Diagnosis of type 2 diabetes mellitus

 -  Must be on a stable treatment regimen (maintained on diet/exercise therapy with or
 without metformin) for at least 4 weeks prior to study entry

 -  Have a glycated haemoglobin (HbA1c) value greater than or equal to 6.5% and less than
 or equal to 10.0% on a stable treatment regimen

 -  Weigh 45.0 kg or more

 -  Have a Body Mass Index (BMI) greater than or equal to 18.5 and less than or equal to
 40.0 kg/m2

 -  Are willing and able to conduct self-blood glucose monitoring tests

 Exclusion Criteria:

 -  Are currently enrolled in, or discontinued within the last 30 days from a clinical
 trial involving use of an investigational drug or device other than the study drug
 used in this study, or are concurrently enrolled in any other type of medical research
 judged not to be compatible with this study

 -  Use of insulin for diabetic control for more than 6 consecutive days within 1 year
 prior to study entry

 -  Use of thiazolidinediones within 3 months, or other oral anti-diabetics (OADs), apart
 from metformin, within 1 month prior to study entry. Metformin is acceptable for this
 study

 -  Previous myocardial infarction, stroke or transient ischaemic event ('TIA'), or
 clinically significant coronary events or symptoms within 6 months prior to study
 entry

 -  Subjects who have any evidence of heart insufficiency, hypokalaemia, family history of
 long-QT-syndrome or are receiving other drugs which extend the QT interval

 -  Clinically significant peripheral vascular disease

 -  Clinical evidence of active diabetic proliferative retinopathy

 -  Known significant autonomic neuropathy

 -  Any patient having experienced a keto-acidotic episode requiring hospitalisation in
 the last 6 months

 -  Symptomatic hyperglycemia exhibited by significant osmotic symptoms (polyuria or
 polydipsia), unanticipated weight loss or dehydration

 -  Evidence of hepatitis B and/or positive hepatitis B surface antigen, at screening

 -  Subjects who have an average weekly alcohol intake that exceeds 21 units per week
 (males) and 14 units per week (females)

 -  Subjects who are heavy smokers (> 10 cigarettes, or equivalent, per day) or are unable
 or unwilling to refrain from nicotine during CRU admissions

 Exclusion Criteria for EU Site only --

 -  Regular use of known drugs of abuse and/or positive findings on urinary drug screening

 -  Evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies

 -  Evidence of hepatitis C and/or positive hepatitis C antibodies