Eligibility NCT01435616 Diabetes Mellitus, Type 2 Inclusion Criteria Exclusion Criteria Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks Yes
No
Use of rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening Yes
No
Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss Yes
No
Have had any episodes of severe hypoglycemia within 6 months prior to screening Yes
No
Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study Yes
No
Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification) Yes
No
Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 mg/dL Yes
No
Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening Yes
No
Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of hemoglobin A1c Yes
No
Have active or untreated malignancy, have been in remission from clinically significant malignancy for less than 5 years Yes
No
Have fasting or nonfasting triglycerides greater than 400 mg/dL (greater than 4.5 mmol/L) at screening Yes
No
Are using lipid lowering medication at a dose that has not been stable for 90 days prior to screening Yes
No
Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening Yes
No
Medical Concepts 
