Introduction
Methods
Study Population
Compliance with Ethics Guidelines
Diabetes Therapy-Related QOL Questionnaire (DTR-QOL) 7
Q1. I am constantly concerned about time to manage my current diabetes treatment |
Q2. I am bothered by weight gain with my current diabetes treatment |
Q3. I am sometimes bothered by low blood glucose |
Q4. I am worried about high blood glucose |
Q5. Overall, I am satisfied with my current blood sugar control |
Q6. With my current diabetes treatment, I am confident that I can maintain good blood glucose control |
Q7. With regards to diabetes treatment, I am satisfied with current treatment methods |
Statistical Analysis
Results
Baseline Characteristics
Parameters | Sitagliptin treatment group (n = 71) | Conventional treatment group (n = 62) |
P value |
---|---|---|---|
Age (years) | 62.6 ± 11.7 | 63.6 ± 9.5 | 0.59 |
Gender (male) (%) | 40 (56.3) | 31 (50) | 0.49 |
Duration of diabetes (years) | 16.8 ± 8.3 | 17.2 ± 8.3 | 0.77 |
eGFR (mL/min/1.73 m2) | 77.8 ± 20.8 | 79.5 ± 22.3 | 0.65 |
Body mass index (kg/m2) | 25.7 ± 4.4 | 25.3 ± 4.0 | 0.57 |
HbA1c (%) | 8.3 ± 1.2 | 8.0 ± 1.1 | 0.15 |
Total daily insulin dosage (IU/day) | 32.3 ± 22.8 | 29.4 ± 22.3 | 0.46 |
Time of insulin injections (times/day) | 3.0 ± 1.1 | 3.1 ± 1.0 | 0.77 |
Type of insulin | |||
Prandial insulin (yes) | 41 (57.7) | 39 (62.9) | 0.60 |
Premixed insulin (yes) | 35 (49.3) | 18 (29) | 0.02 |
Basal insulin (yes) | 31 (43.7) | 33 (53.2) | 0.30 |
Use of oral glucose-lowering agents | |||
Metformin (yes) | 31 (43.7) | 25 (35.5) | 0.38 |
Sulfonylurea (yes) | 11 (15.5) | 8 (12.9) | 0.81 |
Glinides (yes) | 0 (0) | 0 (0) | – |
Thiazolidinediones (yes) | 9 (12.7) | 4 (6.5) | 0.26 |
α-Glucosidase inhibitor (yes) | 31 (43) | 24 (38.7) | 0.60 |
Parameters | Completion of questionnaire at week 104 (n = 86) | No completion of questionnaire at week 104 (n = 47) |
P value |
---|---|---|---|
Age (years) | 63.9 ± 10.0 | 61.5 ± 11.8 | 0.22 |
Gender (male) (%) | 44 (51.2) | 27 (57.4) | 0.59 |
Body mass index (kg/m2) | 25.7 ± 4.1 | 25.1 ± 4.5 | 0.37 |
Duration of diabetes (years) | 17.7 ± 8.6 | 15.6 ± 7.7 | 0.16 |
HbA1c (%) | 8.2 ± 1.2 | 8.1 ± 1.2 | 0.50 |
eGFR (mL/min/1.73 m2) | 77.4 ± 20.6 | 80.7 ± 22.9 | 0.39 |
Total daily insulin dosage (IU/day) | 33.0 ± 24.1 | 27.3 ± 18.8 | 0.046 |
Time of insulin injections (times/day) | 3.2 ± 1.0 | 2.8 ± 1.1 | 0.16 |
Type of insulin | |||
Prandial insulin (yes) | 58 (67.4) | 22 (46.8) | 0.026 |
Premixed insulin (yes) | 35 (49.3) | 21 (44.7) | 0.46 |
Basal insulin (yes) | 42 (48.8) | 22 (46.8) | 0.86 |
Use of oral glucose-lowering agents | |||
Metformin (yes) | 25 (25.9) | 28 (59.6) | <0.001 |
Sulfonylurea (yes) | 14 (16.3) | 5 (10.6) | 0.45 |
Glinides (yes) | 0 (0) | 0 (0) | – |
Thiazolidinediones (yes) | 10 (11.6) | 3 (6.4) | 0.38 |
α-Glucosidase inhibitors (yes) | 21 (24.4) | 34 (72.3) | <0.001 |
Parameters | Sitagliptin treatment group (n = 45) | Conventional treatment group (n = 41) |
P value (intergroup) | |||
---|---|---|---|---|---|---|
Baseline | Week 104 | Baseline | Week 104 | Baseline | Week 104 | |
Age (years) | 62.6 ± 11.9 | – | 65.4 ± 7.2 | – | 0.19 | – |
Gender (male) (%) | 25 (55.6) | – | 19 (46.3) | – | 0.52 | – |
Body mass index (kg/m2) | 26.1 ± 4.4 | 25.8 ± 4.5 | 25.3 ± 3.7 | 25.6 ± 4.7 | 0.37 | 0.82 |
Duration of diabetes (years) | 17.1 ± 8.7 | – | 18.4 ± 8.4 | – | 0.50 | |
HbA1c (%) | 8.4 ± 1.2 | 7.7 ± 1.7** | 8.0 ± 1.1 | 7.7 ± 1.3 | 0.21 | 0.51 |
eGFR (mL/min/1.73 m2) | 78.3 ± 21.3 | 73.6 ± 25.8** | 76.4 ± 20.0 | 73.5 ± 21.2 | 0.67 | 0.98 |
Total daily insulin dosage (IU/day) | 3.2 ± 1.1 | 2.9 ± 1.3 | 3.2 ± 0.9 | 3.2 ± 1.0 | 0.77 | 0.35 |
Time of insulin injections (times/day) | 34.5 ± 24.6 | 30.2 ± 22.7* | 31.4 ± 23.8 | 29.0 ± 19.7 | 0.56 | 0.79 |
Type of insulin | ||||||
Prandial insulin (yes) | 30 (66.7) | 28 (65.1) | 28 (68.7) | 28 (68.7) | 1.00 | 0.82 |
Premixed insulin (yes) | 18 (40.0) | 15 (34.9) | 14 (34.1) | 11 (26.8) | 0.66 | 0.48 |
Basal insulin (yes) | 24 (53.3) | 25 (58.1) | 18 (43.9) | 23 (56.1) | 0.40 | 1.00 |
Use of oral glucose-lowering agents | ||||||
Metformin (yes) | 15 (33.3) | 15 (33.3) | 10 (24.4) | 9 (22.0) | 0.48 | 0.34 |
Sulfonylurea (yes) | 8 (17.8) | 8 (17.8) | 6 (14.6) | 7 (17.1) | 0.79 | 1.00 |
Glinides (yes) | 0 (0) | 1 (2.2) | 0 (0) | 1 (2.4) | – | 1.00 |
Thiazolidinediones (yes) | 8 (17.8) | 8 (17.8) | 2 (4.9) | 2 (4.9) | 0.09 | 0.09 |
α-Glucosidase inhibitor (yes) | 12 (26.7) | 12 (24.4) | 9 (22) | 9 (22) | 0.63 | 0.80 |
Factor Analysis and Internal Consistency
Question number | Factor 1 |
---|---|
Q1 |
0.36
|
Q2 | −0.02 |
Q3 |
0.43
|
Q4 |
0.46
|
Q5 |
0.68
|
Q6 |
0.76
|
Q7 |
0.58
|
Temporal Change in DTR-QOL7 Scores
Variables | Sitagliptin treatment group | Conventional treatment group |
P value (intergroup) | |
---|---|---|---|---|
Total score of DTR-QOL7 (excluding Q2) | Baseline | 50.0 (38.9, 58.3) (n = 71) | 52.8 (41.7, 66.7) (n = 62) | 0.28 |
Week 104 | 63.9 (44.4, 77.8) (n = 49) | 52.8 (44.4, 66.7) (n = 45) | 0.25 | |
Change from baseline | 8.3 (−5.6, 22.2)** (n = 45) | 2.8 (−8.3, 13.9) (n = 41) | 0.24 | |
Treatment effect | 4.7 (−3.0, 12.4) | 0.23 | ||
Score of Q1 | Baseline | 4.0 (3.0, 6.0) (n = 71) | 4.5 (3.0, 6.0) (n = 62) | 0.69 |
Week 104 | 4.0 (3.0, 7.0) (n = 49) | 5.0 (4.0, 6.0) (n = 45) | 0.87 | |
Change from baseline | 0.0 (0.0, 2.0) (n = 45) | 0.0 (1.0, 1.0) (n = 41) | 0.85 | |
Treatment effect | 0.1 (−0.7, 0.8) | 0.86 | ||
Score of Q3 | Baseline | 5.0 (3.0, 7.0) (n = 71) | 6.0 (4.0, 7.0) (n = 62) | 0.47 |
Week 104 | 6.0 (4.0, 7.0) (n = 49) | 5.0 (3.0, 6.0) (n = 45) | 0.21 | |
Change from baseline | 0.0 (−1.0, 1.0) (n = 45) | 0.0 (1.0, 1.0) (n = 41) | 0.52 | |
Treatment effect | 0.4 (−0.3, 1.2) | 0.25 | ||
Score of Q4 | Baseline | 3.0 (2.0, 4.0) (n = 70) | 3.0 (2.0, 4.0) (n = 62) | 0.83 |
Week 104 | 4.0 (2.0, 6.0) (n = 49) | 4.0 (2.0, 6.0) (n = 44) | 0.60 | |
Change from baseline | 0.0 (−1.0, 2.0) (n = 45) | 0.0 (−0.5, 1.0) (n = 40) | 0.80 | |
Treatment effect | 0.2 (−0.6, 1.0) | 0.57 | ||
Score of Q5 | Baseline | 4.0 (2.0, 4.0) (n = 71) | 4.0 (2.0, 5.0) (n = 62) | 0.66 |
Week 104 | 4.0 (4.0, 6.0) (n = 49) | 4.0 (3.0, 6.0) (n = 45) | 0.16 | |
Change from baseline | 0.0 (0.0, 2.0)** (n = 45) | 0.0 (−1.0, 2.0) (n = 41) | 0.29 | |
Treatment effect | 0.5 (−0.3, 1.3) | 0.23 | ||
Score of Q6 | Baseline | 4.0 (3.0, 5.0) (n = 71) | 4.0 (3.0, 5.0) (n = 62) | 0.58 |
Week 104 | 4.0 (4.0, 6.0) (n = 49) | 4.0 (4.0, 5.0) (n = 45) | 0.22 | |
Change from baseline | 0.0 (0.0, 1.0)* (n = 45) | 0.0 (−1.0, 2.0) (n = 41) | 0.73 | |
Treatment effect | 0.3 (−0.4, 0.9) | 0.42 | ||
Score of Q7 | Baseline | 4.0 (3.0, 6.0) (n = 71) | 4.0 (4.0, 6.0) (n = 62) | 0.30 |
Week 104 | 5.0 (4.0, 6.0) (n = 49) | 4.0 (4.0, 6.0) (n = 45) | 0.32 | |
Change from baseline | 1.0 (0.0, 2.0) (n = 45) | 0.0 (0.0, 1.0) (n = 41) | 0.25 | |
Treatment effect | 0.2 (−0.5, 0.9) | 0.62 | ||
Score of Q2 | Baseline | 4.0 (3.0, 7.0) (n = 70) | 5.0 (4.0, 7.0) (n = 62) | 0.23 |
Week 104 | 5.5 (4.0, 7.0) (n = 48) | 5.0 (4.0, 7.0) (n = 45) | 0.59 | |
Change from baseline | 0.0 (0.0, 1.5) (n = 44) | 0.0 (−1.0, 1.0) (n = 41) | 0.49 | |
Treatment effect | 0.1 (−0.6, 0.9) | 0.68 |