Background
Methods
Research overview
DTR-QOL questionnaire
Statistical analysis
Results
Subject characteristics
Characteristics | Value |
---|---|
Age, years | 59.4 ± 12.3 |
Height, cm | 162.6 ± 9.6 |
Duration of diabetes, months | 115.0 ± 88.8 |
Men | 119 (58.3) |
Macrovascular complications of diabetes | 36 (17.7) |
Arteriosclerosis obliterans | 8 (3.9) |
Coronary heart disease | 19 (9.3) |
Stroke | 15 (7.3) |
Diabetic microangiopathy | 106 (52.0) |
Diabetic retinopathy | 49 (24.0) |
Diabetic neuropathy | 47 (23.0) |
Diabetic nephropathy | 83 (40.6) |
Sulfonylurea before using GLP-1 | 123 (60.3) |
Drugs | Baseline (n = 204) | Week 12 (n = 204) |
---|---|---|
Antidiabetic drug | 140 (68.6) | 138 (67.7) |
Sulfonylurea | 114 (55.9) | 113 (55.4) |
α-Glucosidase inhibitor | 19 (9.3) | 18 (8.8) |
Biguanide | 47 (23.0) | 49 (24.0) |
DPP-4 inhibitor | 8 (3.9) | 7 (3.4) |
Glinide | 3 (1.5) | 3 (1.5) |
Thiazolidinedione | 10 (4.9) | 10 (4.9) |
Other | 1 (0.5) | 0 (0.0) |
Antihypertensive drug | 121 (59.3) | 123 (60.3) |
Diuretic drug | 22 (10.8) | 20 (9.8) |
Calcium channel blocker | 75 (36.8) | 77 (37.8) |
ACE inhibitor | 9 (4.4) | 8 (3.9) |
Angiotensin II receptor blocker | 95 (46.6) | 98 (48.0) |
Direct renin inhibitor | 0 (0.0) | 0 (0.0) |
α-blocker | 0 (0.0) | 0 (0.0) |
β-blocker | 17 (8.3) | 18 (8.8) |
α1β-blocker | 4 (2.0) | 5 (2.5) |
α2 receptor agonist | 1 (0.5) | 1 (0.5) |
Other | 2 (1.0) | 2 (1.0) |
Lipid-lowering agent | 117 (57.4) | 118 (57.8) |
Statin | 103 (50.5) | 102 (50.0) |
Fibrate | 12 (5.9) | 12 (5.9) |
Ezetimibe | 6 (2.9) | 8 (3.9) |
Probucol | 0 (0.0) | 0 (0.0) |
EPA | 0 (0.0) | 0 (0.0) |
Resin | 0 (0.0) | 0 (0.0) |
Other | 4 (2.0) | 4 (2.0) |
Dose (mg) | Baseline (n = 204) | Week 12 (n = 204) |
---|---|---|
0.3 | 186 (91.2) | 19 (9.3) |
0.6 | 3 (1.5) | 28 (13.7) |
0.9 | 15 (7.4) | 157 (77.0) |
Effects of liraglutide on clinical and biochemical parameters, and incidence of hypoglycemia
Items | Mean value ± SD |
n
| Change (SE) |
p value | |
---|---|---|---|---|---|
Baseline | Week 12 | ||||
Weight (kg) | 73.9 ± 17.0 | 72.5 ± 16.7 | 204 | −1.4 (0.3) | <0.001 |
BMI (kg/m2) | 27.9 ± 5.3 | 27.3 ± 5.2 | 203 | −0.5 (0.1) | <0.001 |
Systolic blood pressure (mmHg) | 131.1 ± 15.4 | 129.4 ± 16.0 | 203 | −1.8 (1.2) | 0.134 |
Diastolic blood pressure (mmHg) | 76.0 ± 11.6 | 76.4 ± 12.2 | 203 | 0.4 (0.8) | 0.652 |
HbA1c (NGSP, %) | 8.7 ± 1.5 | 7.5 ± 1.3 | 203 | −1.2 (0.1) | <0.001 |
Random blood glucose level (mg/dL) | 199 ± 80 | 170 ± 66 | 198 | −29.0 (5.8) | <0.001 |
RBCs (×104/μL) | 459 ± 54 | 458 ± 50 | 135 | −1.1 (2.5) | 0.661 |
WBCs (/mm3) | 6887 ± 1879 | 6913 ± 1876 | 135 | 26.4 (140.4) | 0.851 |
Hemoglobin (g/dL) | 13.9 ± 1.6 | 13.9 ± 1.5 | 135 | 0.0 (0.1) | 0.886 |
Hematocrit (%) | 41.6 ± 4.2 | 41.8 ± 4.2 | 135 | 0.2 (0.2) | 0.225 |
Blood platelets (×104/μL) | 22.5 ± 6.2 | 23.1 ± 5.7 | 134 | 0.6 (0.4) | 0.088 |
AST (IU/L) | 28.1 ± 20.6 | 26.6 ± 19.3 | 162 | −1.5 (1.1) | 0.176 |
ALT (IU/L) | 36.1 ± 33.1 | 33.5 ± 29.0 | 160 | −2.7 (1.6) | 0.090 |
γGTP (IU/L) | 50.0 ± 52.7 | 50.2 ± 64.8 | 153 | 0.2 (2.9) | 0.943 |
Serum creatinine (mg/dL) | 0.9 ± 1.0 | 0.9 ± 0.9 | 162 | 0.0 (0.0) | 0.215 |
Uric acid (mg/dL) | 5.6 ± 1.5 | 5.4 ± 1.4 | 151 | −0.2 (0.1) | 0.025 |
TC (mg/dL) | 189.1 ± 36.5 | 180.8 ± 32.2 | 117 | −8.4 (2.8) | 0.003 |
HDL-C (mg/dL) | 50.9 ± 12.9 | 49.7 ± 12.5 | 155 | −1.2 (0.6) | 0.041 |
TG (mg/dL) | 177.9 ± 130.3 | 172.3 ± 100.8 | 166 | −5.6 (7.4) | 0.451 |
Effects of liraglutide on DTR-QOL scores
Domain | Score |
n
|
p value | Effect size
| ||
---|---|---|---|---|---|---|
Baseline | Week 12 | |||||
D1: | Burden on social activities and daily activities | 68.2 ± 20.2 | 73.9 ± 19.8 | 204 | <0.001 | 0.28 |
D2: | Anxiety and dissatisfaction with treatment | 51.1 ± 21.9 | 61.5 ± 21.9 | 201 | <0.001 | 0.48 |
D3: | Hypoglycemia | 75.4 ± 26.0 | 81.5 ± 23.2 | 200 | 0.002 | 0.23 |
D4: | Satisfaction with treatment | 48.3 ± 21.5 | 61.4 ± 21.3 | 202 | <0.001 | 0.61 |
Total score | 61.9 ± 16.2 | 69.7 ± 16.8 | 198 | <0.001 | 0.48 |
Domain | Questions | Score |
n
|
p value | ||
---|---|---|---|---|---|---|
Baseline | Week 12 | |||||
D1: burden on social activities and daily activities | Q1 | My current diabetes treatment interferes with my work and activities | 4.9 ± 2.0 | 5.5 ± 1.8 | 204 | <0.001 |
Q2 | My current diabetes treatment limits the scope of my activities | 5.1 ± 2.0 | 5.6 ± 1.7 | 203 | <0.001 | |
Q3 | It is difficult to find places on time for my current diabetes treatment | 5.4 ± 1.7 | 5.8 ± 1.6 | 203 | 0.001 | |
Q4 | My current diabetes treatment interferes with group activities and personal friendships | 5.4 ± 1.8 | 5.8 ± 1.7 | 204 | 0.007 | |
Q5 | It is a burden getting up at a certain time every morning for my current diabetes treatment | 5.8 ± 1.7 | 5.9 ± 1.5 | 204 | 0.151 | |
Q6 | With my current diabetes treatment, the restricted meal times are a burden | 5.1 ± 1.9 | 5.7 ± 1.6 | 204 | <0.001 | |
Q7 | When I eat out, it is difficult to manage my current diabetes treatment | 4.8 ± 1.9 | 5.4 ± 1.8 | 203 | <0.001 | |
Q8 | I feel like my current diabetes treatment takes away the enjoyment of eating | 4.3 ± 1.9 | 4.8 ± 1.9 | 204 | <0.001 | |
Q9 | With my current diabetes treatment, it is hard to curb my appetite | 3.8 ± 2.0 | 4.6 ± 1.9 | 204 | <0.001 | |
Q10 | The time and effort to manage my current diabetes treatment are a burden | 5.0 ± 1.7 | 5.3 ± 1.7 | 204 | 0.018 | |
Q11 | I am constantly concerned about time to manage my current diabetes treatment | 5.2 ± 1.7 | 5.6 ± 1.6 | 204 | 0.002 | |
Q12 | Pain due to my current diabetes treatment is uncomfortable | 5.9 ± 1.6 | 5.4 ± 1.7 | 204 | <0.001 | |
Q13 | Gastrointestinal symptoms (nausea, passing gas, diarrhea, abdominal pain) due to my current diabetes treatment are uncomfortable | 5.7 ± 1.7 | 5.2 ± 1.9 | 204 | 0.001 | |
D2: anxiety and dissatisfaction with treatment | Q14 | I am bothered by weight gain with my current diabetes treatment | 4.7 ± 2.0 | 5.6 ± 1.7 | 200 | <0.001 |
Q19 | I have uncomfortable symptoms due to hyperglycemia (high blood glucose) | 5.0 ± 2.0 | 5.4 ± 1.7 | 200 | 0.012 | |
Q20 | I am worried about high blood glucose | 3.5 ± 2.0 | 4.6 ± 2.0 | 199 | <0.001 | |
Q21 | I am dissatisfied that my blood glucose is unstable (high and low) | 3.9 ± 1.9 | 4.7 ± 1.7 | 201 | <0.001 | |
Q22 | I am worried that complications might get worse with my current diabetes treatment | 3.3 ± 2.0 | 4.1 ± 2.0 | 201 | <0.001 | |
Q23 | I get anxious thinking about living while on my current diabetes treatment | 3.9 ± 2.0 | 4.4 ± 1.9 | 201 | 0.001 | |
Q24 | I find it unbearable to think that even if I continue my current diabetes treatment, my diabetes may not be cured | 3.9 ± 1.9 | 4.3 ± 1.8 | 203 | <0.001 | |
Q25 | I am concerned that if I continue my current diabetes treatment, the efficacy may diminish | 4.5 ± 1.8 | 4.5 ± 1.8 | 203 | 0.822 | |
D3: hypoglycemia | Q15 | I worry about low blood glucose due to my current diabetes treatment | 5.3 ± 1.8 | 5.5 ± 1.6 | 201 | 0.100 |
Q16 | I am scared because of low blood glucose | 5.6 ± 1.7 | 6.0 ± 1.5 | 200 | <0.001 | |
Q17 | I am sometimes bothered by low blood glucose | 5.7 ± 1.7 | 6.1 ± 1.4 | 200 | 0.001 | |
Q18 | Symptoms due to low blood glucose are uncomfortable | 5.6 ± 1.8 | 5.9 ± 1.6 | 199 | 0.002 | |
D4: satisfaction with treatment | Q26 | Overall, I am satisfied with my current blood sugar control | 3.2 ± 1.7 | 4.3 ± 1.8 | 202 | <0.001 |
Q27 | With my current diabetes treatment, I am confident that I can maintain good blood glucose control | 3.7 ± 1.6 | 4.6 ± 1.5 | 202 | <0.001 | |
Q28 | I am hopeful about the future with my current diabetes treatment | 4.5 ± 1.5 | 4.9 ± 1.4 | 204 | 0.001 | |
Q29 | With regards to diabetes treatment, I am satisfied with current treatment methods | 4.1 ± 1.5 | 5.0 ± 1.4 | 204 | <0.001 |