Table 2.
Study (reference) | Comparator | Additional glucose-lowering treatment | Trial duration (weeks) | No. participants (ITT) in the insulin detemir group | Baseline HbA1c (%) |
Endpoint HbA1c (%) |
Mean weight change (kg) |
Hypoglycemia (relative risk for detemir) |
Mean endpoint SMFPG (mmol/L) |
Within-patient SD in FPG (mmol/L) |
|
---|---|---|---|---|---|---|---|---|---|---|---|
Comparator | Comparator | Comparator | 24 hours | Nocturnal | Comparator | Comparator | |||||
Haak et al63 | NPH | Insulin aspart | 26 | 341 | 7.9 | 7.6 | +1.0 | 0.84 | 1.02 | 9.7 | 1.3 |
164 | 7.8 | 7.5 | +1.8* | 9.6 | 1.4* | ||||||
dPhilis-Tsimikas et al65 | NPH | OADs | 20 | 165/169 | 9.08/8.88 | 7.50/7.40 | +1.2/+0.7 | 0.68/0.47* | 0.13***/0.35* | 7.97/6.50 | Not reported |
164 | 9.15 | 7.35 | +1.6** | 6.78 | Not reported | ||||||
Hermansen et al61 | NPH | OADs | 24 | 227 | 8.6 | 6.8 | 1.2 | 0.53*** | 0.45*** | 6.9a | 0.88 |
225 | 8.5 | 6.6 | 2.8*** | 0.94 | 1.05 | 6.6a | 0.99** | ||||
Rosenstock et al66 | Insulin glargine | OADs | 52 | 291 | 8.64 | 7.16 | +3.0 | 7.14a | 1.06 | ||
291 | 8.62 | 7.12 | +3.9** | 6.98a | 1.03 | ||||||
Hollander et al67 | Insulin glargine | Insulin aspart | 52 | 214 | 8.6 | 7.19 | +2.8 | 0.75 | 0.63/1.15 (OD/BID) | 7.05 | 1.36 |
105 | 8.8 | 7.03 | +3.8* | 6.68 | 1.39 |
Notes: Study also compared detemir OD in the morning with detemir OD in the evening. Results from both are shown here;
P < 0.05;
P < 0.01;
P < 0.001.
Abbreviations: FPG, fasting plasma glucose; NPH, neutral protamine Hagedorn insulin; HbA1c, glycosylated hemoglobin; ITT, intent to treat; OAD, oral antidiabetic; OD, once daily; BID, twice daily; SMFPG, self-measured fasting plasma glucose; SD, standard deviation.