American Diabetes Association

Table 1—

Baseline demographics

	Placebo TID	Pramlintide 90 μg BID	Pramlintide 120 μg BID
n (ITT)	161	171	166
Sex (% M/F)	52/48	49/51	48/52
Age (years)	56.4 ± 10.2	57.0 ± 10.2	56.9 ± 10.5
Race (%)
White	75	77	73
Black	12	14	13
Hispanic	12	8	13
Other	1	1	1
Body weight (kg)^*	96.8 ± 20.5	97.1 ± 19.3	96.7 ± 23.2
BMI (kg/m²)	33.7 ± 7.2	33.8 ± 6.3	34.1 ± 7.5
Diabetes duration (years)^*	12.4 ± 7.0	12.0 ± 6.6	12.1 ± 7.3
HbA_1c (%)^*	9.3 ± 1.3	9.1 ± 1.1	9.0 ± 1.1

	Placebo TID	Pramlintide 90 μg BID	Pramlintide 120 μg BID
n (ITT)	161	171	166
Sex (% M/F)	52/48	49/51	48/52
Age (years)	56.4 ± 10.2	57.0 ± 10.2	56.9 ± 10.5
Race (%)
White	75	77	73
Black	12	14	13
Hispanic	12	8	13
Other	1	1	1
Body weight (kg)^*	96.8 ± 20.5	97.1 ± 19.3	96.7 ± 23.2
BMI (kg/m²)	33.7 ± 7.2	33.8 ± 6.3	34.1 ± 7.5
Diabetes duration (years)^*	12.4 ± 7.0	12.0 ± 6.6	12.1 ± 7.3
HbA_1c (%)^*	9.3 ± 1.3	9.1 ± 1.1	9.0 ± 1.1

Concomittant therapies	Week 0	Week 52	Week 0	Week 52	Week 0	Week 52
Total daily insulin dose (units)^*	74	76	70	72	69	70
Type of insulin used (%)^†
Short-acting only	0	0	1	2	1	0
Long-acting only	14	15	21	19	17	18
Short- and long-acting	86	85	78	79	82	82
Injections/day (%)^†
1 injection	9	5	7	6	9	8
2 injections	68	73	73	72	72	70
3+ injections	23	22	20	22	19	22
Oral anti-hyperglycemic agents, (%)^†	27	27	26	23	23	21
Metformin only	14	14	13	13	9	9
Sulfonylureas only	10	12	7	9	9	10
Metformin and sulfonylureas	2	2	6	5	5	5

Concomittant therapies	Week 0	Week 52	Week 0	Week 52	Week 0	Week 52
Total daily insulin dose (units)^*	74	76	70	72	69	70
Type of insulin used (%)^†
Short-acting only	0	0	1	2	1	0
Long-acting only	14	15	21	19	17	18
Short- and long-acting	86	85	78	79	82	82
Injections/day (%)^†
1 injection	9	5	7	6	9	8
2 injections	68	73	73	72	72	70
3+ injections	23	22	20	22	19	22
Oral anti-hyperglycemic agents, (%)^†	27	27	26	23	23	21
Metformin only	14	14	13	13	9	9
Sulfonylureas only	10	12	7	9	9	10
Metformin and sulfonylureas	2	2	6	5	5	5

*

Values are mean ± standard deviation;

†

proportion of subjects