Table 2.
Metabolism related variables before and at the end of treatment
| Before treatment (mean (standard deviation or range)) | End of treatment (mean (standard deviation or range)) | Change from before treatment (mean (standard error, coefficient of variation, or 95% confidence interval)) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Metformin + insulin (n=52) | Repaglinide + insulin (n=49) | Metformin + insulin (n=51) | Repaglinide + insulin (n=47) | ΔMetformin + insulin (n=51) | ΔRepaglinide + insulin (n=47) | ΔMetformin + insulin versus ΔRepaglinide + insulin | P value | |||
| Glycaemic control (primary outcome) | ||||||||||
| HaemoglobinA1c concentration (%) | 8.15 (1.32) | 8.07 (1.49) | 6.72 (0.66) | 6.90 (0.68) | −1.42 (0.09) | −1.23 (0.10) | −0.18 (−0.45 to 0.08) | 0.177 | ||
| Glycaemic control (secondary outcomes) | ||||||||||
| Mean plasma glucose (mmol/l)* | 10.66 (2.76) | 10.55 (3.20) | 7.63 (1.28) | 8.02 (0.98) | −3.12 (0.17) | −2.72 (0.17) | −0.40 (−0.89 to 0.08) | 0.103 | ||
| Total daily insulin dose (units)† | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) | 32.96 (9 to 84) | 28.25 (6 to 108) | 32.96 (48.1) | 28.25 (74.6) | 1.17 (0.90 to 1.51) | 0.233 | ||
| Anthropometric variables | ||||||||||
| Body weight (kg) | 72.07 (10.98) | 72.67 (10.16) | 74.45 (12.27) | 77.66 (12.11) | 2.22 (0.54) | 4.73 (0.57) | −2.51 (−4.07 to −0.95) | 0.002 | ||
Data for before treatment (baseline; 0 months) and end of treatment (12 months with last observation carried forward) are presented as raw absolute (unadjusted) values and are summarised as mean (standard deviation), whereas data for the changes from baseline are baseline adjusted changes (including last observation carried forward) and are summarised as mean (standard error or 95% confidence interval, except for insulin dose†). The last observation was carried forward for HbA1c and insulin dose, but not for mean plasma glucose or body weight. The number of patients in each column represents the maximum number of patients with available measurements either at baseline or in the intention to treat analysis at the end of treatment.
*Mean of seven point self monitored plasma glucose.
†Baseline and end of treatment data are presented as geometric mean (range), whereas changes from baseline are presented as either geometric mean (coefficient of variation) or the ratio between treatment effects (95% confidence interval).