Status of PTDMa Tacrolimus/AZA CsA/AZA
Patients without pre-transplant history of diabetes mellitus 151 151
New onset PTDMa, 1st Year 30/151 (20%) 6/151 (4%)
Still insulin-dependent at one year in those without prior history of diabetes 25/151 (17%) 5/151 (3%)
New onset PTDMa post 1 year 1 0
Patients with PTDMa  at 2 years 16/151 (11%) 5/151 (3%)

a) Use of insulin for 30 or more consecutive days, with < 5 day gap, without a prior history of insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus.

Table 11. Development of Post-Transplant Diabetes Mellitus by Race or Ethnicity and by Treatment Group During First Year Post Kidney Transplantation in a Phase 3 Trial

Patient Race Patients Who Developed PTDMa
Tacrolimus Cyclosporine
Black 15/41 (37%) 3 (8%)
Hispanic 5/17 (29%) 1 (6%)
Caucasian 10/82 (12%) 1 (1%)
Other 0/11 (0%) 1 (10%)
Total 30/151 (20%) 6 (4%)

a) Use of insulin for 30 or more consecutive days, with < 5 day gap, without a prior history of insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus.

Liver Transplant
Insulin-dependent PTDM was reported in 18% and 11% of Tacrolimus-treated liver transplant patients and was reversible in 45% and 31% of these patients at 1 year post-transplant, in the U.S. and European randomized trials, respectively, (Table 12). Hyperglycemia was associated with the use of Tacrolimus in 47% and 33% of liver transplant recipients in the U.S. and European randomized trials, respectively, and may require treatment [see Adverse Reactions (6.1)].

Table 12. Incidence of Post-Transplant Diabetes Mellitus and Insulin Use at 1 Year in Liver Transplant Recipients

Status of PTDMa US Trial European Trial
Tacrolimus Cyclosporine Tacrolimus Cyclosporine
Patients at riskb 239 236 239 249
New Onset PTDMa 42 (18%) 30 (13%) 26 (11%) 12 (5%)
Patients still on insulin at 1 year 23 (10%) 19 (8%) 18 (8%) 6 (2%)

a) Use of insulin for 30 or more consecutive days, with < 5 day gap, without a prior history of insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus.

b) Patients without pre-transplant history of diabetes mellitus.

Heart Transplant

Insulin-dependent PTDM was reported in 13% and 22% of Tacrolimus-treated heart transplant patients receiving mycophenolate mofetil (MMF) or azathioprine (AZA) and was reversible in 30% and 17% of these patients at one year post-transplant, in the U.S. and European randomized trials, respectively (Table 13). Hyperglycemia defined as two fasting plasma glucose levels ≥126 mg/dL was reported with the use of Tacrolimus plus MMF or AZA in 32% and 35% of heart transplant recipients in the U.S. and European randomized trials, respectively, and may require treatment [see Adverse Reactions (6.1)].

Table 13. Incidence of Post-Transplant Diabetes Mellitus and Insulin Use at 1 Year in Heart Transplant Recipients

Status of PTDMa US Trial European Trial    
  Tacrolimus /MMF Cyclosporine/MMF Tacrolimus/ AZA Cyclosporine/AZA
Patients at riskb 75  83 132 138
New Onset PTDMa 10 (13%) 6 (7%) 29 (22%) 5 (4%)
Patients still on insulin at1 yearc 7 (9%) 1 (1%) 24 (18%) 4 (3%)

a) Use of insulin for 30 or more consecutive days without a prior history of insulin-dependent diabetes mellitus or non-insulin dependent diabetes me