Pioglitazone (PIO) as Adjunctive Therapy in Adolescents with Type 1 Diabetes (T1D)

Pioglitazone (PIO) as Adjunctive Therapy in Adolescents with Type 1 Diabetes (T1D) Insulin resistance (IR) during Insulin resistance (IR) during puberty may contribute to poorer metabolic control (ie, higher A1C) in adolescents with T1D. Adjunctive therapy with metformin modestly improves A1C levels in these teens. The objective of this study was to determine if addition of a more potent insulin sensitizer, the thiazolidinedione PIO, to usual insulin therapy also leads to improved A1C in pubertal patients with T1D and IR. We conducted a 2 site, randomized, placebo-controlled, double-blind 6-month trial of 30mg PIO versus placebo (PLAC) in 38 adolescents with T1D, high insulin dose ([gt]0.9U/kg/day), and suboptimal A1C ([gt]7.5%). We spoke to each subject by telephone at least weekly to help achieve and maintain as near normoglycemia as possible.

Baseline characteristics of patients who completed the study

	Pioglitazone (9F/9M)	Placebo (9F/8M)
Age (years)	14.3[plusmn]1.9	14.7[plusmn]2 [lowast]
Duration of diabetes(years)	5.7[plusmn]3.1	7[plusmn]3.9[lowast]
BMI SDS	0.8[plusmn]1.1	1.3[plusmn]0.6[lowast]
Injections TID/QID/pump	9/6/1	14/3/2[lowast]
Insulin dose(U/kg/day)	1.3[plusmn]0.4	1.4[plusmn]2[lowast]
A1C (%)	8.8[plusmn]0.9	8.8[plusmn]0.9[lowast]

Data are expressed as mean[plusmn]SD;[lowast] nsThere was 1 dropout (personal reasons) and 2 withdrawals: one severe hypoglycemia (PIO) and one elevated hepatic enzymes (PLAC). After 6 months, both groups had improved metabolic control (p[lt]0.05); (mean change in A1C in the PIO group was [ndash]0.4[plusmn] 0.9 vs [ndash]0.5 [plusmn]1.2% in the PLAC group). There were no significant differences between the 2 groups at 6 months in either A1C or insulin dose. There was a small, but significant decrease in cholesterol and LDL (no change in triglycerides and HDL levels) in the PIO group compared to PLAC, although values remained normal. BMI SDS increased by 0.3 in the PIO group and remained unchanged in the PLAC group (p=0.01). Subjects in the PIO group had slightly but not significantly more severe/moderate hypoglycemia compared to the PLAC group (2/4 vs 0/2). We conclude that adjunctive PIO therapy was not effective in improving glycemic control in adolescents with T1D, but the lipid effects suggest potential antiatherogenic benefits. VERA ZDRAVKOVIC, JILL HAMILTON, DENIS DANEMAN, ELIZABETH CUMMINGS 1882-P Toronto, ON, Canada; Halifax, NS, Canada Pediatrics - Type 1 Diabetes