RESULTS
diarrhoea, nausea, colorectal cancer, death, abdominal pain, gastrointestinal adverse, acute illness, pyrosis, intracardiac thrombus, left ventricular heart failure, dysthymia, heart failure, dilated cardiomyopathy, diabetes
COLORECTAL CANCER, LIVER METASTASES, LACK OF APPETITE, ADVERSE EVENTS, ST SEGMENT ELEVATION MYOCARDIAL INFARCTION, INTRACARDIAC THROMBUS, ACUTE PERITONITIS, HEART FAILURE, DILATED CARDIOMYOPATHY, ASYMPTOMATIC HYPOGLYCAEMIA, DIABETES
Between February 2016 and December 2019, 93 MDI‐treated people were enrolled and switched to IDegLira. Soon after BV 4 persons withdrew consent (ceased therapy due to financial reasons) and 4 patients gradually reduced and finally stopped IDegLira due to repeated low SMBG values before Visit 1, and remained well‐controlled on non‐insulin treatment. Three patients discontinued IDegLira in a few days due to moderate gastrointestinal adverse effects, 1 patient had to be converted to MDI due to acute illness, 6 participants did not return to the scheduled visits, and 3 patients died during the follow‐up. Finally, 72 patients (baseline age 63.8 ± 9.5 years, HbA1c 6.4 ± 0.7% [46 ± 8 mmol/mol], BMI 33.01 ± 6.47 kg/m2, body weight 92.92 ± 18.83 kg, TDD 43.21 ± 10.80 IU/day, insulin requirement 0.48 ± 0.13 IU/kg, duration of diabetes 9.7 ± 7.5 years; mean ± SD) completed the 12‐month trial (Table Patient characteristics at baseline and during follow‐up visits6.4(0.7)6.2(0.7)−0.2(−0.3 to 0.0)−3.89(−5.35 to −2.43)−1.41(−1.92 to −0.89)−21.24(−23.41 to −19.06)0.48(0.13)0.24(0.09)−0.22(−0.25 to −0.20)1850[0–2000]2000[1000–2000]2000[1000–2000]2000[1000–2000]
From the Friedman test followed by Dunn's post hoc test for metformin dose and from repeated measures ANOVA followed by Fisher's LSD post hoc test for other parameters.At baseline and at 12 months visit 47 (65.3%) and 70 (97.2%) patients were taking metformin.At baseline, 62 (86%) patients were on a basal‐bolus regimen using one dose of basal and 3 doses of prandial insulins (46 used human and 16 used analogue insulins), and 10 (14%) patients were treated with 2 or 3 doses of human or analogue premix insulins.At BV, 47 (65.3%) patients were taking metformin (median daily dose was 1850 mg), mean number of daily insulin injections was 3.82 ± 0.54, and mean C‐peptide was 3.96 ± 2.47 ng/ml.During the 12‐month follow‐up, adequate glycaemic control was maintained by the simplified treatment (Figure Change in HbA1c levels (A) and body weight (B) during the 12‐month follow‐up (Body weight and BMI decreased significantly (Figure Percentage of patients experiencing at least one documented or symptomatic hypoglycaemia was 48.6% (Proportions of participants reaching different prespecified glycaemic targets are summarized in Figure Proportions of patients who had achieved various glycaemic targets at Visit 3In the subgroup with a baseline HbA1c < 6.5% (48 mmol/mol) (Change in HbA1c levels (means ± SEM) during the 12‐month follow‐up in the subgroup of patients (A), and with a baseline HbA1c ≥ 6.5% to ≤7.5% (In the subgroup with a baseline HbA1c ≥ 6.5% to ≤7.5% (48 and 58 mmol/mol) (After 12 months of follow‐up, the mean dose of IDegLira was 21.97 ± 8.15 dosage units (mean dose of liraglutide was 0.79 mg), 70 (97.2%) patients were taking metformin (median dose of metformin was 2000 [1000–2000] mg) and the mean insulin requirement decreased from 0.48 ± 0.13 IU/kg at BV to 0.25 ± 0.09 IU/kg at Visit 3. Mean daily number of injections changed from 3.82 ± 0.54 to 1, and the patients could also substantially reduce the daily number of blood glucose testing.IDegLira + metformin combination was safe and generally well tolerated. Transient gastrointestinal adverse events (lack of appetite, abdominal pain, nausea, pyrosis, diarrhoea, and in 2 cases vomitus) were reported by 18 patients (25%), and 2 patients had transient dysthymia. Serious adverse events were rare. One patient had non‐fatal acute non‐ST segment elevation myocardial infarction, 1 patient was newly diagnosed with heart failure and dilated cardiomyopathy complicated with intracardiac thrombus and acute peritonitis, and 3 patients died during the follow‐up. One patient with known dilated cardiomyopathy died of acute left ventricular heart failure, while two patients were diagnosed with and died of colorectal cancer with liver metastases. In the opinion of the investigators, none of the serious adverse events and death cases were related to IDegLira + metformin combination therapy.