NCT00566813 trial results

Inclusion Criteria: * Type 1 diabetes \> 5 years complicated by at least one of the following situations despite intensive insulin management: * Reduced awareness of hypoglycemia at plasma glucose levels \< 54 mg/dL * Metabolic lability/instability characterized by two or more episodes of severe hypoglycemia or hospital visits for diabetic ketoacidosis over the last year * Progressive secondary complications of diabetes: * Retinopathy-three step progression using the ETDRS grading system or equivalent progression; * Nephropathy- microalbuminuria rise of 50 µg/min (72 mg/24h) over three months within the past two years despite using an ACE inhibitor; * Neuropathy-persistent gastroparesis, postural hypotension, neuropathic bowel or bladder, or severe peripheral neuropathy unresponsive to management Exclusion Criteria: * Co-existing cardiac disease: * Myocardial infarction within past six months * Angiographic evidence of non-correctable coronary artery disease * Ischemia on functional cardiac exam d. Heart failure \> NYHA II * Active alcohol or substance abuse or cigarette smoking * Psychiatric disorder: schizophrenia, bipolar disorder, or major depression that is unstable on medication * Non-adherence to prescribed regimens * Active infection including hepatitis C, hepatitis B, HIV * TB by history, current infection, or under treatment for suspected TB * History of malignancies except squamous or basal skin cancer * Stroke within the past 6 months * BMI \> 26 kg/m2 or body weight \> 70 kg at screening visit * C-peptide response to glucagon stimulation, any C-peptide ≥ 0.3 ng/mL * Inability to provide informed consent * Age less than 18 or greater than 65 years * Creatinine clearance \< 85 mL/min/1.73 m2 by 24-hour urine collection * Serum creatinine \> 1.5 mg/dL * Macroalbuminuria \> 300 mg/24h * Baseline Hb \< 12 gm/dL in women, \< 13 gm/dL in men * Baseline liver function tests outside normal range * Untreated proliferative retinopathy * Positive pregnancy test, intent for pregnancy, male's intent to procreate, unwilling to use effective contraception, breast-feeding * Previous transplant or PRA reactivity \> 20%) * Insulin requirement \> 0.7 IU/kg/day * HbA1C \> 12% * Hyperlipidemia * Chronic use of steroids * Use of coumadin or other anticoagulant (except aspirin) or PT INR \> 1.5 * Addison's disease * Allergy to radiographic contrast material