Effect of metformin versus placebo on follow-up (intermediate and study visit) levels of HbA1c and insulin doses in 72 patients with type-1 diabetes during a one year period.

Follow-up HbA1c data were obtained from planned study visits as well as from intermediate non-study outpatient clinic visits during the intervention period. All HbA1c measurements obtained at least one month post-randomization were evaluated. Data are shown for the subgroup of 72 patients having available follow-up HbA1c measurements from one to four months post-randomization. Data at baseline (0 month) and follow-up are raw absolute values given as mean (standard deviation) or median (range). Data for ��Metformin and ��Placebo represent the mean (95% confidence interval) estimated changes from baseline as predicted by the statistical model.aThe first available follow-up HbA1c measurement (in the group of 72 patients presented here, all the ��first available�� HbA1c data were obtained at intermediate outpatient clinic visits). Given change from baseline estimates (i.e., ��Metformin, ��Placebo and ��Metformin versus ��Placebo) represent data without adjustment for time. Additional adjustment for time did not change conclusions substantially (data not shown).bTime from randomization until the first available HbA1c measurement.cThe last available follow-up HbA1c measurement (obtained from study visits or intermediate outpatient clinic visits, that is, equal to EOT levels including last observation carried forward).dTotal daily insulin dose represents the last reported dose at the intermediate telephone consultations within the first three months post-randomization. The total insulin doses corrected for body weight (i.e. Units/kg) are not shown since data for body weight at the date of reporting insulin doses (i.e. at the intermediate telephone consultations) were not available.Abbreviations:EOT: End of treatment.HbA1c: HaemoglobinA1c.

干预期间，糖化血红蛋白（HbA1c）的随访数据来源于计划内研究访视，以及非研究计划的中期门诊就诊。本研究纳入了随机分组后至少1个月获取的所有糖化血红蛋白检测结果。本次展示的数据来自72例患者的亚组，该亚组均具备随机分组后1至4个月的随访糖化血红蛋白检测数据。
基线（0个月）及随访时的原始绝对数值以均值（标准差）或中位数（极差）的形式呈现。二甲双胍（Metformin）组与安慰剂（Placebo）组的相关数据为统计模型预测得到的、相较于基线的平均变化值（95%置信区间）。
注a：本次展示的72例患者亚组中，所有首次可获取的糖化血红蛋白随访数据均来自中期门诊就诊。本次展示的相较于基线的变化估计值（即二甲双胍组、安慰剂组以及二甲双胍与安慰剂组的组间对比数据）未进行时间校正。额外的时间校正并未对研究结论产生实质性影响（相关数据未展示）。
注b：从随机分组至首次可获取糖化血红蛋白检测结果的时间间隔。
注c：末次可获取的糖化血红蛋白随访检测结果（来自研究访视或中期门诊就诊，等同于包含末次观测结转法的治疗结束（End of Treatment, EOT）时的检测水平）。
注d：每日总胰岛素剂量为随机分组后前3个月内中期电话问诊中上报的末次剂量。由于无法获取胰岛素剂量上报当日（即中期电话问诊当日）的体重数据，因此未展示经体重校正后的总胰岛素剂量（单位：U/kg）。
缩写说明：
EOT：治疗结束（End of Treatment）
HbA1c：糖化血红蛋白（Haemoglobin A1c）