Table 1.

Published interventional studies in adolescents with T2DM

Author, yr	Intervention	N	Study population	Randomized	Outcome measures	Study visits	Duration of study	Retention (%)	Comment on recruitment and/or retention
Jones et al., 2002 (7)	1–2 g metformin Placebo	42 40	All T2DM	Yes (double blind)	Mean change in FPG, HbA1c, weight, BMI, lipid, stimulated C-peptide	2	16 wk	75.7	481 screened; 82 randomized; 6 (14.3%) subjects on metformin and 4 (10.0%) on placebo discontinued during the double-blind period
Sellers and Dean, 2004 (11)	70/30 insulin*	18	All T2DM	No (open label)	Mean change in HbA1c	6	≤16 wk therapy and 12 months follow-up	Not reported	No data available on completion
FDA, 2004†	500 mg metformin 2.5 mg glyburide 1.25/250 mg Met/Gly	54 49 57	All T2DM	Yes (double blind)	Mean change in HbA1c	2	26 wk	Not reported	167 enrolled; 160 ITT
Gottschalk et al. 2007 (8)	1–8 mg glimepiride 1–2 g metformin	132 131	All T2DM	Yes (single blind)	Mean change in HbA1c and fasting SMBG	6	24 wk	80	536 screened; 285 randomized; 263 ITT; 210 patients completed the study
Gellar et al., 2009 (10)	1 high GI meal and 1 low GI meal	11	T2DM (5) IGT (6)	Yes (cross-over)	Mean blood glucose and blood glucose variability	2	4 d	100	Due to difficult recruitment, expansion of inclusion criteria to include IGT
Malloy et al., 2009 (9)	2.5 μg exenatide 5.0 μg exenatide Placebo	13	All T2DM	Yes (cross-over)	Pharmacokinetics and safety profile; glucose, insulin, and glucagon measurements	3	5 wk	92	13 randomized; 12 completed

T2DM, type 2 diabetes mellitus; FPG, fasting plasma glucose; HbA1c, hemoglobin A1c; BMI, body mass index; FDA, Food and Drug Administration; ITT, intention to treat; SMBG, self-monitored blood glucose; GI, glycemic index; IGT, impaired glucose tolerance.

^*Insulin was initiated at a starting dose of 0.5 U/kg/day in two doses. Insulin dose was titrated to maintain blood glucose in the target range of 4–7 mmol/L. Mean maximum insulin dose was 0.76 U/kg/day reached at 2.3 wk.

^†Unpublished data available from the FDA.