| Literature DB >> 27181199 |
Ming-Nan Chien1,2,3, Yen-Ling Chen4, Yi-Jen Hung5, Shu-Yi Wang6, Wen-Tsung Lu7, Chih-Hung Chen8, Ching-Ling Lin9, Tze-Pao Huang10, Ming-Han Tsai11, Wei-Kung Tseng12,13, Ta-Jen Wu14, Cheng Ho15, Wen-Yu Lin16, Bill Chen17, Lee-Ming Chuang18.
Abstract
AIMS/Entities:
Keywords: Insulin therapy; Observational study; Type 2 diabetes mellitus
Mesh:
Substances:
Year: 2016 PMID: 27181199 PMCID: PMC5089951 DOI: 10.1111/jdi.12532
Source DB: PubMed Journal: J Diabetes Investig ISSN: 2040-1116 Impact factor: 4.232
Baseline characteristics
| Characteristics | Evaluable population ( |
|---|---|
| Mean age (years) | 62.2 ± 12.4 |
| Male, | 413 (50.1) |
| Female, | 412 (49.9) |
| Mean weight (kg) | 66.3 ± 13.0 |
| Mean height (cm) | 160.7 ± 8.5 |
| Mean diabetes duration (years) | 11.6 ± 7.0 |
| Mean OAD duration (years) | 10.7 ± 6.6 |
| Previous insulin therapy | |
| No. patients (%) | 57 (6.9) |
| Mean interruption (years) | 3.2 ± 2.9 |
| Complications, | |
| Diabetic neuropathy | 184 (22.2) |
| Diabetic nephropathy | 180 (21.8) |
| Diabetic retinopathy | 166 (20.0) |
| Comorbidities, | |
| Dyslipidemia | 561 (67.8) |
| Hypertension | 529 (64.3) |
| Coronary artery disease | 100 (12.1) |
| Stroke | 32 (3.9) |
| Vascular disorder | 13 (1.8) |
| Mean HbA1c (%) | 10.1 ± 1.9 |
| Mean FBG (mg/dL) | 230.6 ± 68.8 |
The percentages were calculated based on the number of patients with evaluable data rather than the total eligible population. FBG, fasting blood glucose; HbA1c, glycated hemoglobin; OAD, oral antidiabetic medications.
Summary of oral antidiabetic medications and insulin
| Baseline | Change at week 12 | Change at week 24 | |
|---|---|---|---|
| OAD, | |||
| Sulfonylurea/metformin | 343 (41.0) | 59 (7.7) | 42 (6.0) |
| Sulfonylurea | 335 (40.1) | 67 (8.7) | 39 (5.5) |
| Metformin | 279 (33.4) | 30 (3.9) | 20 (2.8) |
| Dipeptidyl peptidase‐4 inhibitor | 183 (21.9) | 50 (6.5) | 22 (3.1) |
| Alpha‐glucosidase inhibitor | 159 (19.0) | 45 (5.9) | 34 (4.8) |
| Thiazolidinedione | 88 (10.5) | 34 (4.4) | 2 (0.3) |
| Glinides | 77 (9.2) | 14 (1.8) | 14 (2.0) |
| Thiazolidinedione/metformin | 8 (1.0) | 9 (1.2) | 2 (0.3) |
| Dipeptidyl peptidase 4 inhibitor/metformin | 1 (0.1) | 1 (0.1) | 0 (0.0) |
The percentages were calculated based on the number of patients with evaluable data rather than the total eligible population. †Results on oral antidiabetic medications (OAD) at week 12 and week 24 present the population with changes in OAD (change in dose or change to the listed OAD). ‡Fixed dose combination. §At week 12, no patients (n = 0) were taking insulin detemir, and at week 24, there was one patient (n = 1) taking insulin detemir. NA, not applicable; NPH, neutral protamine Hagedorn.
Summary of treatment goal achieving rate
| Achieved | Achieved without severe hypoglycemia | Achieved without any hypoglycemia | HbA1c <6.5% | HbA1c <7% | FBG <130 mg/dL | |
|---|---|---|---|---|---|---|
| Week 12 | ||||||
| Achieved, | 53 (8.3) | 52 (8.1) | 47 (7.3) | 13 (2.0) | 45 (6.9) | 236 (33.7) |
| Not achieved, | 588 (91.7) | 589 (91.9) | 594 (92.7) | 638 (98.0) | 606 (93.1) | 465 (66.3) |
| Week 24 | ||||||
| Achieved, | 72 (11.9) | 71 (11.7) | 59 (9.7) | 19 (3.1) | 66 (10.7) | 208 (32.3) |
| Not achieved, | 534 (88.1) | 535 (88.3) | 547 (90.3) | 597 (96.9) | 550 (89.3) | 436 (67.7) |
The percentages were calculated based on the number of patients with evaluable data rather than the total eligible population. FBG, fasting blood glucose; HbA1c, glycated hemoglobin.
Summary of glycated hemoglobin and fasting blood glucose
|
| Mean ± SD | Change ( | Change ± SD |
| |
|---|---|---|---|---|---|
| HbA1c (%) | |||||
| Baseline | 836 | 10.1 ± 1.9 | |||
| Week 12 | 651 | 8.9 ± 1.6 | 651 | −1.1 ± 1.9 | <0.0001 |
| Week 24 | 616 | 8.7 ± 1.7 | 616 | −1.4 ± 2.1 | <0.0001 |
| FBG (mg/dL) | |||||
| Baseline | 810 | 230.6 ± 68.8 | |||
| Week 12 | 679 | 160.9 ± 57.7 | 662 | −66.6 ± 73.2 | <0.0001 |
| Week 24 | 619 | 159.1 ± 55.6 | 600 | −67.4 ± 72.3 | <0.0001 |
P‐value by paired t‐test, statistically significant; n is the number of patients with evaluable data. FBG, fasting blood glucose; HbA1c, glycated hemoglobin.
Treatment response at week 24
| HbA1c (%) | Baseline HbA1c | |||
|---|---|---|---|---|
| FBG (mg/dL) | Q1 (7.1–8.6%) | Q2 (8.7–9.7%) | Q3 (9.8–11%) | Q4 (11.1–19.1%) |
| No. patients | 170 | 183 | 169 | 176 |
| HbA1c <7%, | 23 (16.4) | 16 (10.4) | 12 (8.3) | 9 (6.2) |
| Mean HbA1c | 8.1 ± 0.4 | 9.2 ± 0.3 | 10.3 ± 0.4 | 12.5 ± 1.5 |
| Mean HbA1c change | −0.1 ± 1.4 | −0.8 ± 1.4 | −1.6 ± 1.7 | −3.1 ± 2.2 |
| FBG <130 mg/dL, | 58 (38.9) | 46 (30.5) | 47 (31.2) | 32 (22.5) |
| Mean FBG | 187.5 ± 51.8 | 211.4 ± 52.1 | 238.4 ± 57.8 | 276.8 ± 58.8 |
| Mean FBG | −38.0 ± 56.8 | −55.0 ± 67.5 | −75.5 ± 67.6 | −104.7 ± 75.1 |
The percentages were calculated based on the number of patients with evaluable data rather than the total eligible population. FBG, fasting blood glucose; HbA1c, glycated hemoglobin.