Patient demographics and clinical characteristics
A total of 1946 patients diagnosed with T2DM were identified in the database. Following study criteria, 582 of these patients had a basal HbA1c measurement <7.0% and were not included in the analysis; 330 patients also did not have a second HbA1c measurement ≥90 days after the first, probably due to clinical inertia, and were also not included in the analysis, consequently, a total of 1034 patients were analyzed for the primary and secondary objectives, as shown in Figure 1. Details on the demographic and clinical characteristics of the study patients are presented in Table 1. A total of 49.9% of the patients were male; mean age of study participants was 60.5 years old. Mean body mass index (BMI) was 29.1 kg/m²; mean systolic and diastolic blood pressure were 136.1 and 78.9 mmHg, respectively; mean serum cholesterol was 180.7 mg/dl; mean LDL-C was 105.4 mg/dl; and mean serum creatinine was 0.9mg/dl.
Figure 1. Patients included in the analysis according to study criteria
Table 1. Baseline demographic and clinical characteristics of the study population
Characteristic
|
Mean (SD)
|
Gender, n(%)
|
|
Male
|
516 (49.9%)
|
Female
|
518 (50.1%)
|
Age (years)
|
60.5 (12.0)
|
BMI (Kg/m²)
|
29.1 (5.6)
|
Systolic blood pressure (mmHg)
|
136.1 (20.5)
|
Diastolic blood pressure (mmHg)
|
78.9 (10.9)
|
Cholesterol (mg/dl)
|
180.7 (45.6)
|
LDL-C (mg/dl)
|
105.4(36.6)
|
Creatinine (mg/dl)
|
0.9 (0.3)
|
Number of patients achieving HbA1c Goal
In the study population, the average basal HbA1c was 9.9% ±2.2, and the average final HbA1c was 7.8% ± 1.9. Patients had a minimum of two HbA1c assessments, spaced by at least 90 days; mean interval between baseline and final HbA1c measurement was 14.1±10.0 months.
In total, 624 patients did not achieve glycemic target (HbA1c <7%), while the remaining 410 patients did achieve the treatment target, as shown in Figure 2.
Figure 2. Proportion of patients with HbA1c <7% after minimum 3 months treatment
Prevalence of comorbidities
The prevalence of nutritional status and comorbidities were evaluated for the total population. For nutritional status, patients were classified based on the WHO criteria. Significant comorbidities such as hypertension, elevated cholesterol, elevated LDL, chronic kidney disease and retinopathy were classified separately, while all other comorbidities (Atrial fibrillation, angina pectoris, myocardial infarction, congestive heart failure, stroke, transient ischemic attack, chronic liver disease, renal replacement therapy, dementia, depression, amputation, peripheral neuropathy, retinopathy, peripheral vascular disease, rheumatoid arthritis, NAFLD) were grouped as OTHER, due to the very low prevalence of each one individually registered in the database. Patients who presented one or more comorbidities were considered as positive for comorbidities.
A total of 941/1034 (91.0%) of patients presented with at least one comorbidity. The number of comorbidities varied from zero to seven. The prevalence of all registered comorbidities in this patient population are described in Table 2.
Table 2. Prevalence of comorbidities in the study population
|
Frequency
|
Percentage
|
At least one comorbidity
|
941/1034
|
91.0%
|
Nutritional status
|
|
|
Normal* (BMI <25.0)
|
236 / 1034
|
22.8%
|
Pre-obesity (BMI 25.0 – 29.9)
|
395 / 1034
|
38.2%
|
Obesity I (BMI 30.0 – 34.9)
|
265 / 1034
|
25.6%
|
Obesity II (BMI 35.0 – 39.9)
|
95 / 1034
|
9.2%
|
Obesity III (BMI >40.0)
|
43 / 1034
|
4.2%
|
Hypertension
|
359 / 1034
|
34.7%
|
Elevated cholesterol
|
285 / 993
|
28.7%
|
Elevated LDL
|
211 / 994
|
21.2%
|
Chronic kidney disease (CKD)
|
31 / 1034
|
3.0%
|
Retinopathy
|
54 / 1034
|
5.2%
|
Other comorbidities
|
192 / 1034
|
18.6%
|
*9 patients would be considered as underweight. For the purposes of this analysis, those patients were categorized as normal nutritional status.
Antidiabetic therapy and number of agents prescribed.
The mean antidiabetic treatment time was 11.1± 6.4 months for the study population. The number of antidiabetic agents prescribed varied from 1 to 5, including oral medications and insulin.
Patients were classified as: Oral Monotherapy (without insulin); Oral Dual therapy (without insulin); Oral Triple or more (without insulin); Insulin (as monotherapy) or Insulin in combination with one or more oral agents. The proportion of patients in each category is shown on Figure 3.
Figure 3. Proportion of patients according to prescribed antidiabetic therapy
Comparison of clinical and demographic variables between patients, classified according to diabetes control (HbA1c < or ≥7%) – univariate analysis
Clinical and demographic variables, as well as comorbidities and number of antidiabetic agents were compared between the groups of patients that achieved and didn’t achieve the HbA1c goal of <7.0%, as shown in Table 3, Table 4 and Table 5.
Table 3. Comparison of clinical and demographical characteristics between HbA1c goal achievement groups
|
Final HbA1c ≥7%
(Diabetes not controlled)
|
Final HbA1c <7% (Diabetes controlled)
|
|
N
|
624
|
410
|
|
|
Frequency (%)
|
Frequency (%)
|
p*
|
Female
|
333 (53.4%)
|
185 (45.1%)
|
0.011*
|
Male
|
291 (46.6%)
|
225 (54.9%)
|
|
|
Mean±SD
|
Mean±SD
|
P**
|
Age (years)
|
61.3±11.8
|
59.3±12.3
|
0.009
|
BMI (Kg/m2)
|
29.0±5.6
|
29.2±5.6
|
0.448
|
Systolic blood pressure (mmHg)
|
136.8±20.8
|
135.0±20.1
|
0.166
|
Diastolic blood pressure (mmHg)
|
78.9±11.2
|
79.0±10.4
|
0.930
|
Cholesterol (mg/dl)
|
184.8±47.4
|
174.4±42.0
|
<0.001
|
LDL-C (mg/dl)
|
107.5±37.7
|
102.3±34.6
|
0.028
|
Creatinine (mg/dl)
|
0.9±0.3
|
0.9±0.4
|
0.169
|
Basal HbA1c (%)
|
10.0±2.1
|
9.7±2.3
|
0.020
|
Final HbA1c (%)
|
8.9±1.8
|
6.2±0.5
|
0.001
|
Final – Baseline HbA1c measurement interval (months)
|
15.1±10.5
|
12.5±8.8
|
<0.001
|
Treatment time (months)
|
11.7±6.5
|
10.3±6.3
|
0.001
|
Number of antidiabetic agents
|
2.3±0.9
|
1.8±0.7
|
<0.001
|
* Yates continuity corrected Chi-square test
** Student t test
Table 4. Comparison of the prevalence of comorbidities between HbA1c goal achievement groups
|
Final HbA1c ≥7%
(Diabetes not controlled)
|
Final HbA1c <7% (Diabetes controlled)
|
|
|
Frequency (%)
|
Frequency (%)
|
p*
|
Any comorbidity (at least one)
|
571/624 (91.5%)
|
370/410 (90.2%)
|
0.560
|
Nutritional status
|
|
|
|
Normal
|
148/624 (23.7%)
|
88/410 (21.5%)
|
0.592
|
Pre-obesity
|
236/624 (37.8%)
|
159/410 (38.8%)
|
Obesity I
|
155/624 (24.8%)
|
110/410 (26.8%)
|
Obesity II
|
62/624 (9.9%)
|
33/410 (8.0%)
|
Obesity III
|
23/624 (3.7%)
|
20/410 (4.9%)
|
Hypertension
|
217/624 (34.8%)
|
142/410 (34.6%)
|
0.963
|
Elevated cholesterol
|
185/599 (30.9%)
|
100/394 (25.4%)
|
0.071
|
Elevated LDL-C
|
134/600 (22.3%)
|
77/394 (19.5%)
|
0.331
|
Chronic kidney disease (CKD)
|
13/624 (2.1%)
|
18/410 (4.4%)
|
0.052
|
Retinopathy
|
37/624 (5.9%)
|
17/410 (4.1%)
|
0.264
|
Other comorbidities
|
133/624 (21.3%)
|
59/410 (14.4%)
|
0.007
|
* Chi-square test
Table 5. Comparison of antidiabetic treatment regimens between HbA1c goal achievement groups
|
Final HbA1c ≥7%
(Diabetes not controlled)
|
Final HbA1c <7% (Diabetes controlled)
|
|
N
|
624
|
410
|
|
|
Frequency (%)
|
Frequency (%)
|
p*
|
Monotherapy (without insulin)
|
112 (17.9%)
|
167 (40.7%)
|
<0.001
|
Dual therapy (without insulin)
|
200 (32.1%)
|
164 (40.0%)
|
0.011
|
Triple therapy (without insulin)
|
131 (21.0%)
|
45 (11.0%)
|
<0.001
|
Insulin (as monotherapy)
|
13 (2.1%)
|
5 (1.2%)
|
0.426
|
Insulin in combination with one or more oral agent
|
168 (26.9%)
|
29 (7.1%)
|
<0.001
|
* Yates continuity corrected Chi-square test: p<0.001