Table 2.
Clinical characteristics of patients, showing change from baseline to week 28
| Parameter | Patients (n = 234) | Change from baseline to week 28 (p)a |
||
|---|---|---|---|---|
| Baseline | Week 14 | Week 28 | ||
| Male:female (%) | 49:51 | |||
| Age (years) | 64.9 ± 8.2 | |||
| Duration of diabetes mellitus (years) | 16.1 ± 7.5 | |||
| Body weight (kg) | 97.8 ± 18.6 | 94.8 ± 17.8 | 94.0 ± 17.8 | 0.0001 |
| BMI (kg/m2) | 33.9 ± 5.4 | 32.9 ± 5.2 | 32.6 ± 5.0 | 0.0001 |
| C-peptide (nmol/l) | 0.75 ± 0.43 | |||
| Total daily dose of insulin (IU/day) | 55.6 ± 13.5 | 31.1 ± 9.3 | 32.7 ± 10.1 | 0.0001 |
| Metformin (%) | 85.0% | 84.6% | 86.8% | n.s |
| SGLT2 inhibitors (gliflozins) (%) | 24.8% | 17.9% | 18.4% | n.s |
| DPP-4 inhibitors (gliptins) (%) | 12% | 0% | 0% | 0.0001 |
| Sulphonylureas (%) | 7.3% | 9.0% | 12.4% | n.s |
| PPARγ agonists (glitazones) (%) | 0% | 0% | 0% | n.s |
| HbA1c (%, DCCT) | 8.6 ± 1.0 | 7.7 ± 1.2 | 7.6 ± 1.1 | 0.0001 |
| Arterial hypertension (%) | 90.6% | |||
| Dyslipidemia (%) | 77.7% | |||
| Cholesterol—total (mmol/l) | 4.7 ± 1.1 | 4.5 ± 1.1 | 4.4 ± 1.0 | 0.01 |
| Triglycerides (mmol/l) | 2.1 ± 1.2 | 1.9 ± 1.1 | 1.8 ± 0.9 | 0.0001 |
| HDL-cholesterol (mmol/l) | 1.2 ± 0.3 | 1.2 ± 0.4 | 1.2 ± 0.3 | n.s |
| LDL-cholesterol (mmol/l) | 2.8 ± 1.0 | 2.6 ± 0.9 | 2.6 ± 0.8 | 0.01 |
| Systolic blood pressure (mmHg) | 141.4 ± 17.3 | 135.5 ± 14.5 | 135.2 ± 14.6 | 0.0001 |
| Diastolic blood pressure (mmHg) | 81.1 ± 9.8 | 79.6 ± 8.8 | 79.5 ± 8.6 | 0.05 |
| ALT (μkat/l) | 0.57 ± 0.45 | 0.52 ± 0.29 | 0.48 ± 0.25 | 0.001 |
| GGT(μkat/l) | 0.76 ± 0.85 | 0.70 ± 0.61 | 0.66 ± 0.61 | 0.001 |
| Smoking of cigarettes (%) | 12.8% | |||
| Hypoglycemia based on SMBG | ||||
| Number of episodes of symptomatic, confirmed hypoglycemia < 3.9 mmol/l/patient/month | 0.38 ± 0.10 | 0.05 ± 0.40 | 0.10 ± 0.46 | 0.001 |
| Number of episodes of severe hypoglycemia/patient/month | 0.03 ± 0.14 | 0 | 0 | 0.05 |
| Proportion of patients with at least 1 hypoglycemic event/month (%) | 16.20 | 3.42 | 4.70 | 0.001 |
Values in table are presented as the mean ± standard deviation (SD) or as a percentage, as appropriate
ALT Alanine aminotransferase, DDP-4 dipeptidyl peptidase 4, GGT gamma glutamyl transferase, HDL/LDL high-/low-density lipoprotein, n.s. not statistically significant, PPARγ peroxisome proliferator-activated receptor gamma, SGLT2 sodium-glucose cotransporter-2
aUnless indicated otherwise (n.s.), values at week 28 are significantly different from those at baseline at the level indicated