Treatment Injected Insulin Therapy Oral Antidiabetic Agent Hypoglycemia Study n Glargine NPH Severe Symptomatic Nocturnal All Fritsche et al39 236 X Glimepiride 2.1% 56% 17% 74% 227 X Glimepiride 1.8% 43%// 23% 68% 232 X Glimepiride 2.6% 58% 38% 75% HOE 901/2004 Study Investigators Group37 64 X¶ NA 0 17.2%# 6.3%** 18.8% 72 X NA 0 22.2%# 8.3% 25% 68 X NA 0 29.4%# 19.1% 32.4% Janka et al38 177 X Glimepiride + metformin 0 2.62 0.51** 4.07** 187 X None 0.05 5.73 1.04 9.87 Riddle et al5 367 X NA 14 13.9** 4.0** ... 389 X NA 9 17.7 6.9 ... Ryysy et al22 NA X Metformin ... 5.5** ... ... NA X Metformin ... 8.0 ... ... Yki-Järvinen et al40 214 X Acarbose, metformin, sulfonylurea ... ... 12.6%**//// 33.0%**//// 208 X Acarbose, metformin, sulfonylurea ... ... 28.8%//// 50.7%////

Abbreviations: NA, not available; NPH, neutral protamine Hagedorn.

^* Some studies report data for the entire population while others report intent to treat data.

Expressed as events per patient-year except where indicated by %.

Treatment administered in the morning.

Treatment administered at bedtime.

^// Statistically significant (P<.05) versus NPH insulin and insulin glargine bedtime dosing.

^¶ Insulin glargine administered with 30 µg/mL of zinc.

^# Daytime, nonsevere hypoglycemia.

^** Statistically significant (P<.05) versus NPH insulin.

Nonsevere, symptomatic hypoglycemia.

Treatment administered with 80 µg/mL of zinc.

Premixed insulin (30% regular human insulin and 70% NPH insulin).

^//// Patients achieved fasting blood glucose target (120 mg/dL).