| Outcome Measures: |
Primary: Safety and tolerability of single and multiple subcutaneous doses of DM199, Number of participants with adverse events in the single and multiple ascending dose studies., Up to 13 days after final dose|Determine the pharmacokinetic of DM199 after single and multiple doses, Determine the plasma pharmacokinetic profile of DM199 after administration of single and multiple doses of DM199 in healthy subjects and type 2 diabetes mellitus patients. Measure plasma DM199 levels in individual participants., Up to 3 days after final dose | Secondary: Determine the effect of DM199 on glucose homeostasis in healthy volunteers and type 2 diabetes mellitus patients, Determine the effect of DM199 on glucose homeostasis (via fasting glucose and HbA1c levels), standardized meal tolerance test, C-peptide, fructosamine, GLP-1 (active and total), glucagon, adiponectin and lipids measurements, and homeostatic model assessment of insulin resistance/beta cell function (HOMA) determination in type 2 diabetes mellitus patients, Part C, Day -1 and 14; Part D, Days -1, 14 and 28|Assess formation of ADA to DM199, Assess the formation of antibodies to DM199 after administration of multiple doses of DM199 in healthy subjects and type 2 diabetes mellitus patients, Part C, Day -1 and 42; Part D, Day -1 and 35|Determine changes in immune cell populations by FACS analysis., Determine changes in immune cell populations by fluorescence-activated cell sorting analysis following multiple doses of DM199 in healthy subjects and type 2 diabetes mellitus patients, Part C, Day -1 and 15; Part D, Day -1 and 29
|
