Table 3.
Studies comparing an insulin analog basal-bolus regimen with a human insulin basal-bolus regimen
| Analog regimens versus regular insulin regimens | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Study (reference) | Comparator and additional glucose-lowering treatment | Trial duration (weeks) | Participants (n, ITT) | 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 | ||||
| Hermansen et al53 | NPH with human soluble insulin versus insulin detemir and insulin aspart | 18 | 298 297 |
8.48 8.29 |
7.88 8.11*** |
−0.95 +0.07*** |
0.79* | 0.45*** | 7.58 8.10* |
2.60 3.04*** |
| Rašlová et al64 | NPH with human soluble insulin versus insulin detemir and insulin aspart in patients with type 2 diabetes | 22 | 195 200 |
8.16 8.08 |
7.46 7.52 |
+0.51 +1.13 |
0.87 | 0.54* | 7.28 7.32 |
1.20 1.54*** |
*
P < 0.05;
**
P < 0.01;
***
P < 0.001.
Abbreviations: ITT, intent to treat; NPH, neutral protamine Hagedorn insulin; SD, standard deviation; SMFPG, self-measured fasting plasma glucose. SD, standard deviation; FPG, fasting plasma glucose; SMFPG, self-measured fasting plasma glucose.