J Nutr Health Aging

INADEQUATE GLYCAEMIC CONTROL AND THERAPEUTIC MANAGEMENT

OF ADULTS OVER 65 YEARS OLD WITH TYPE 2 DIABETES MELLITUS IN
SPAIN
F. FORMIGA1, J. FRANCH-NADAL2, L. RODRIGUEZ3, L. ÁVILA4, E. FUSTER5
1. Geriatric Unit, Internal Medicine Department, Hospital Universitari de Bellvitge-IDIBELL, L’Hospitalet de Llobregat, Barcelona, Spain; 2. EAP Raval Sud-ICS Barcelona, DAP-
Cat IDIAP Jordi Gol, Barcelona, Spain; 3. Geriatric Service, Hospital Universitario de Getafe, Madrid, Spain; 4. UGC Vélez Norte, Málaga, Spain; 5. Medical Department, Novartis
Farmacéutica S.A, Barcelona, Spain. Corresponding author: Francesc Formiga, Geriatric Unit, Internal Medicine Department, Hospital Universitari de Bellvitge-IDIBELL, c/Feixa Llarga,
s/n, 08907 L’Hospitalet de Llobregat, Barcelona (Spain), Tel.: + 34 932 607 699, Fax: +34 932 607 967, E-mail: fformiga@bellvitgehospital.cat

Abstract: Objectives: The glycaemic goals for older patients with type 2 diabetes mellitus (DM) are
recommended to avoid an HbA1c levels <7%. The purpose of this study was to analyse the glycaemic control and
therapeutic management of older adults (≥65 years) with type 2 DM. Design: Pooled analysis of patients enrolled
in three Spanish cross-sectional epidemiological studies. Setting: The study was conducted between 2009 and
2011 by primary care or specialist physicians. Participants: A total of 7,269 patients aged ≥65 years with type
2 DM. Measurements: Sociodemographic, medical history, lifestyle habits, biochemical laboratory parameters,
comorbidities, type 2 DM complications, and pharmacological treatment data collected from medical records.
Results: In total, data from 7,269 patients were analysed (mean age 73.4 years old; 48.4% male). A total of
10.9% of patients had HbA1c levels ≥8.5% and 43.2% <7%. The most common comorbidities were hypertension
(82.0%) and dyslipidaemia (76.6%). The microvascular complications were mainly diabetic nephropathy (23.6%)
and retinopathy (19.3%). Oral antidiabetic drugs (OADs) were taken by 70.5% of patients (sulphonylureas
65.3%), 4.1% were taking insulin alone and 25.4% took both insulin and an OAD. Half of the patients (51.0%)
were taking a combination of OADs. Conclusion: In conclusion, more than half of older patients with type 2 DM
had unsatisfactory management: approximately one in ten had inadequate glycaemic control (HbA1c ≥8.5%)
despite hypoglycaemic drugs and four in ten were potentially overtreated (HbA1c <7%).

Key words: Diabetes mellitus, glycaemic control, management, older adults, type 2 diabetes.

Introduction others (8). In this line, the purpose of our study was to analyse
the glycaemic control and the adequacy of treatment patterns in
Type 2 diabetes mellitus (DM) is a highly prevalent older adults with type 2 DM in Spain.
metabolic disease among older people (1). After the publication
in 2011 of the European Diabetes Working Party for Older Methods
People 2011 clinical guidelines for type 2 diabetes mellitus
(2) and in 2012 of the American Diabetes Association (ADA) We present a pooled analysis of a subgroup of patients (≥65
and American Geriatrics Society (AGS) consensus report on years) enrolled in three cross-sectional, epidemiological and
diabetes in older adults (≥65 years) (3), different glycaemic multicentre studies conducted in Spain between 2009 and 2011
goals for this population were proposed that recommended (HIPOQoL (9), OBEDIA (10) and PATHWAYS (11) studies).
avoiding haemoglobin A1c (HbA1c) levels of less than 7% (4). The overall population of these three studies included 14,266
More recently, the global guideline for managing older adult patients (≥18 years) with type 2 DM who attended a
people with type 2 DM, published by the International Diabetes primary care physician or specialist; 7,269 patients were ≥65
Federation (IDF) (1, 5), recommended that glycaemic control years old. The OBEDIA study (10) had body mass index (BMI)
targets should be individualized by taking into account ≥25 kg/m2 (i.e. overweight or obese patients) as an additional
distinct characteristics such as functional status, presence inclusion criterion.
of comorbidities or type 2 DM complications, or risk of Sociodemographic, medical history, lifestyle habits,
hypoglycaemia. Since the incidence of hypoglycaemia is higher biochemical laboratory parameters, comorbidities, type 2
in older type 2 DM patients compared to younger patients, even DM complications, and pharmacological treatment data were
at comparable glycaemic control (6), antidiabetic therapies collected from medical records. The HIPOQoL study did not
with high risk of hypoglycaemia are not recommended for the collect treatment data.
elderly population (7). Body mass index was calculated by dividing the body
Recently, a US study based on a sample of older adults weight by the height squared (kg/m2). Abdominal obesity was
indicated that a substantial proportion of elderly patients with defined as waist circumference >102 cm for men and >88 cm
type 2 DM may be overtreated in clinical practice increasing for women, according to ADA metabolic syndrome criteria.
the risk of serious hypoglycaemia and its consequences such as Systolic and diastolic blood pressures were measured after the
falls, cognitive impairment, or cardiovascular disease among individual had been sitting for several minutes. A smoker was
Received September 1, 2016
Accepted for publication November 2, 2016
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INADEQUATE GLYCAEMIC CONTROL AND THERAPEUTIC MANAGEMENT

Table 1
Demographic, clinical and lifestyle characteristics of older patients with type 2 diabetes mellitus in Spain

Variable 65-74 years n=4,408 ≥75 years n=2,861 Overall (≥65 years) n=7,269
Demographic characteristics:
Age (years), mean ± SD 69.3 ± 2.8* 79.6 ± 3.7* 73.4 ± 6.0
Gender (male), n (%) 2224 (50.7)* 1277 (44.9)* 3501 (48.4)
Anthropometric characteristics:
BMI (kg/m²), mean ± SD 30.7 ± 4.7 30.2 ± 4.8 30.5 ± 4.7
BMI (kg/m²)*, n (%):
<25 326 (7.4) 330 (11.5) 656 (9.0)
25-<30 1813 (41.1) 1177 (41.1) 2990 (41.1)
≥30 2269 (51.5) 1354 (47.3) 3623 (49.8)
Abdominal obesity (yes), n (%) 2736 (70.1)* 1655 (67.5)* 4391 (69.1)
Vital signs:
SBP (mmHg), mean ± SD 139.0 ± 15.0 139.3 ± 15.7 139.1 ± 15.3
DBP (mmHg), mean ± SD 80.7 ± 9.9 78.9 ± 10.6 80.0 ± 10.2
History of diabetes:
Time since diagnosis (years), mean ± 10.1 ± 7.1* 12.2 ± 8.5* 10.9 ± 7.7
SD
Time since diagnosis (years)*, n (%)
<5 1030 (23.9) 534 (19.2) 1564 (22.1)
5-<10 1455 (33.8) 803 (28.8) 2258 (31.8)
10-<15 1000 (23.2) 607 (21.8) 1607 (22.7)
≥15 821 (19.1) 844 (30.3) 1665 (23.5)
Lifestyle habits:
Smoking (yes), n (%) 600 (13.7)* 222 (7.8)* 822 (11.4)
Sedentary (yes), n (%) 2695 (65.3)* 2027 (75.5)* 4722 (69.3)
SD: standard deviation; BMI: body mass index; SBP: systolic blood pressure; DBP: diastolic blood pressure; * p<0.05

defined as either a current smoker or a subject who had stopped exact test, as appropriate, and quantitative variables were
smoking within the previous 12 months. A sedentary person analysed using the t-test or the Mann-Whitney test. A p-value
was defined as a subject who walked less than half hour per <0.05 was considered statistically significant. Statistical
day. Glomerular filtration rate (GFR) was estimated using the analyses were performed using the SAS® statistical package for
abbreviated (four-variable) Modified Diet in Renal Disease Windows (version 9.2, SAS Institute Inc., Cary, NC, USA).
(MDRD-4) equation (12): estimated GFR (ml/min/1.73 m2)
= 186 x (serum creatinine)-1.154 x (age)-0.203 x (0.742 if Results
female) x (1.210 if black).
All study participants provided informed written consent A total of 7,269 older patients with type 2 DM were included
prior to study enrolment. The three studies were reviewed in the analysis. Males accounted for 50.7% of the population
and approved by the ethics committee at Hospital Clínic of between 65-74 years old, and 44.9% of the population aged
Barcelona (Spain). over 75 years old. The mean age was 73.4 ± 6.0 years and the
mean time since type 2 DM diagnosis was 10.9 ± 7.7 years.
Statistical analysis Table 1 lists the main demographic and clinical characteristics
Categorical and continuous variables were summarised as of the study sample. The overall mean BMI value was in the
percentages and mean ± standard deviation (SD), respectively. obese range (≥30 kg/m²). Either obesity, as defined by the BMI,
Missing values were not included in the count. Qualitative or abdominal obesity were significantly lower with increasing
variables were analysed by the Chi-square test or the Fisher age (p<0.05 for both). People aged 75 years or more were less

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Table 2
Analytical values of older patients with type 2 diabetes mellitus in Spain

Parameter, mean ± SD 65-74 years n=4,408 ≥75 years n=2,861 Overall (≥65 years) n=7,269
HbA1c (%) 7.3 ± 1.2 7.2 ± 1.1 7.2 ± 1.2
Fasting glucose (mg/dl) 145.4 ± 43.1 144.0 ± 43.7 144.8 ± 43.4
Serum albumin (g/dl) 4.5 ± 1.1 4.4 ± 1.1 4.5 ± 1.1
Serum creatinine (mg/dl) 1.0 ± 0.5* 1.1 ± 0.4* 1.1 ± 0.4
Urine albumin/ creatinine ratio (mg/g) 4.8 ± 2.5 4.5 ± 2.1 4.7 ± 2.3
LDL-cholesterol (mg/dl) 119.4 ± 36.5 114.7 ± 34.1 117.6 ± 35.6
HDL-cholesterol (mg/dl) 51.4 ± 18.6 50.7 ± 16.0 51.1 ± 17.6
Total cholesterol (mg/dl) 199.0 ± 42.4 192.8 ± 39.1 196.4 ± 41.2
Triglycerides (mg/dl) 155.7 ± 86.9 145.7 ± 66.3 151.6 ± 79.3
eGFR (ml/min/1.73 m2) 76.2 ± 50.2* 68.0 ± 45.7* 72.9 ± 48.6
eGFR (ml/min/1.73 m2)*, n (%)
<15 17 (0.8) 4 (0.3) 21 (0.6)
15-<30 35 (1.6) 44 (2.9) 79 (2.1)
30-<60 572 (25.4) 581 (38.0) 1153 (30.5)
60-<90 1185 (52.6) 723 (47.3) 1908 (50.4)
≥90 446 (19.8) 176 (11.5) 622 (16.4)
SD: standard deviation; LDL: low-density lipoprotein; HDL: high-density lipoprotein; eGFR: estimated glomerular filtration rate; * p<0.05

Table 3
Comorbidities and diabetes complications in older patients with type 2 diabetes mellitus in Spain

Disorder, n (%) 65-74 years n=4,408 ≥75 years n=2,861 Overall (≥65 years) n=7,269
Hypertension 2478 (79.9)* 1798 (85.1)* 4276 (82.0)
Dyslipidaemia 2413 (77.1) 1612 (75.9) 4025 (76.6)
Coronary artery disease 988 (32.6)* 889 (43.5)* 1877 (37.0)
Cerebrovascular disease 254 (6.3)* 340 (12.8)* 594 (8.8)
Peripheral artery disease 509 (12.5)* 435 (16.4)* 944 (14.0)
Diabetic retinopathy 725 (17.8)* 570 (21.4)* 1295 (19.3)
Diabetic nephropathy 880 (21.7)* 705 (26.5)* 1585 (23.6)
Diabetic foot 223 (5.5) 176 (6.6) 399 (5.9)
* p<0.05

Table 4
Concomitant treatments in older patients with type 2 diabetes mellitus in Spain

Treatment, n (%) 65-74 years n=4,408 ≥75 years n=2,861 Overall (≥65 years) n=7,269
Any treatment 2954 (92.8)* 2068 (95.4)* 5022 (93.9)
Antihypertensives 2389 (80.9)* 1737 (84.0)* 4126 (82.2)
Lipid-lowering medications 2209 (74.8)* 1460 (70.6)* 3669 (73.1)
Anticoagulants/ antiplatelets 1648 (55.8)* 1313 (63.5)* 2961 (59.0)
Gastrointestinal drugs 908 (40.3)* 711 (46.1)* 1619 (42.6)
Antidepressants 575 (19.5) 424 (20.5) 999 (19.9)
* p<0.05; Data not available for the HIPOQoL study

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Table 5
Diabetes treatment patterns in older patients with type 2 diabetes mellitus in Spain

65-74 years n=4,408 ≥75 years n=2,861 Overall (≥65 years) n=7,269
Type of therapy*, n (%):
OAD 2286 (72.6) 1428 (67.4) 3714 (70.5)
Insulin 105 (3.3) 111 (5.2) 216 (4.1)
Insulin + OAD 756 (24.0) 580 (27.4) 1336 (25.4)
Type of OAD, n (%):
Monotherapy 1074 (47.2) 753 (52.0) 1827 (49.0)
Free or fixed-dose combination 1204 (52.9) 696 (48.0) 1900 (51.0)
Type of OAD, n (%):
Metformin 1926 (94.0)* 1177 (91.3)* 3103 (93.0)
Sulphonylureas 722 (64.0) 534 (67.3) 1256 (65.3)
DPP4 inhibitors 650 (59.3)* 319 (51.0)* 969 (56.3)
Thiazolidinediones 222 (29.6)* 102 (22.3)* 324 (26.8)
Meglitinides 143 (21.3) 107 (23.6) 250 (22.2)
Alpha-glucosidase inhibitors 59 (9.6) 36 (9.0) 95 (9.3)
GLP-1 receptor agonists 55 (9.1) 32 (8.3) 87 (8.8)
OAD: oral antidiabetic drug; DPP4: dipeptidyl peptidase-4; GLP-1: glucagon-like peptide 1; * p<0.05; Data not available for the HIPOQoL study

likely to smoke compared to patients between 65 and 74 years Figure 1

and were more likely to exhibit sedentary behaviour (p<0.05 for Glycaemic control (HbA1c [%]) in older patients with type 2
both). diabetes mellitus in Spain (n=7,269)
Approximately two thirds (65.8%) of older adults with type 2
DM had HbA1c levels less than 7.5% and 43.2% less than 7%
(Figure 1). Around one out of ten patients (10.9%) had HbA1c
level greater than or equal to 8.5%. The mean HbA1c was
approximately 7% (55 mmol/mol) and the mean fasting glucose
level was 145 mg/dl (8.0 mmol/l) [Table 2].
Table 2 shows additional biochemical laboratory parameters.
Serum albumin, urine albumin/creatinine ratio and lipid levels
were similar between age groups. However, estimated GFR
(eGFR) decreased with increasing age (p<0.05). There was
a higher proportion of patients with an eGFR below 60 ml/
min/1.73 m2 (41.2% vs. 27.8%, p<0.05) or below 30 ml/ Oral antidiabetic drugs (OADs) were prescribed in 70.5%
min/1.73 m2 (3.2% vs. 2.4%, p<0.05) after the age of 75. of cases (metformin in 93.0%, sulphonylureas for 65.3%,
Furthermore, there was a high proportion of hypertension, and dipeptidyl peptidase-4 [DPP4] inhibitors in 56.3%) while
dyslipidaemia and history of coronary artery disease among 4.1% of patients were taking insulin alone and 25.4% were
older patients with type 2 DM (Table 3). The vast majority being treated with both insulin and an OAD (Table 5). A
of patients received concomitant treatment (93.9%), the most total of 51.0% of patients were on free or fixed-dose OAD
common being antihypertensive therapies (82.2%) and lipid- combinations. The proportion of patients on insulin was
lowering medications (73.1 %) [Table 4]. The prevalence of significantly higher with increasing age (27.4% in patients
microvascular complications is reported in Table 3 (mainly between 65-74 years vs. 32.6% in patients ≥75 years)
diabetic nephropathy 23.6% and retinopathy 19.3%). The while OADs such as DPP4 inhibitors (59.3% vs. 51.0%) or
occurrence of comorbidities and type 2 DM complications thiazolidinediones (29.6% vs. 22.3%) decreased with age
increased with age. (p<0.05 for all).

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Discussion disease 37% versus 13%, and peripheral artery disease 14%
versus 9%. On the other hand, the prevalence of diabetic foot
The present study allows to accurately describing the or cerebrovascular disease was lower in our study compared to
characteristics and management of a large cohort of older Brazilian population (6% vs.12% and 9% vs. 12%, respectively)
patients with type 2 DM in Spain. It is worth noting that the (19). As expected, the incidence of both microvascular and
glycaemic control of our study population was tighter than macrovascular complications increased with age.
required by current guidelines (3). Our study shows that more The main strength of the present study is the large sample
than half of patients (54%) had unsatisfactory management: size, representative of routine clinical practice in Spain.
11% had inadequate glycaemic control (HbA1c greater than However, the study has also several limitations. First, its cross-
or equal to 8.5% despite hypoglycaemic agents) and 43% sectional design does not allow the determination of causal
were potentially overtreated (HbA1c less than 7%). Although relationships between treatments and degree of glycaemic
there is a general agreement that avoiding tight glycaemic control. Second, as the HIPOQoL study did not collect any
control minimizes the risk of hypoglycaemia (1), and that it is treatment data, a percentage of patients may be undertaking diet
not indicated in older people (13), these results highlight the and exercise regimen. Therefore, the percentage of overtreated
elevated percentage of tight glycaemic control among older patients may be slightly overestimated. Moreover, we could not
subjects with type 2 DM increasing the risk of iatrogenic exclude those patients with HbA1c level less than 7% who were
hypoglycaemia, an important challenge for health professionals on diet and exercise only and thus, not overtreated. In addition,
nowadays (14). as a functional assessment of subjects was not performed, we
Our results are consistent with that reported by Barrot-de la cannot define the degree of glycaemic control with absolute
Puente et al (15) who found a high percentage of patients with precision. Finally, patients who were overweight or obese were
an HbA1c level less than 7% among older type 2 DM patients overrepresented in this study as one of the studies had this
(between 54-61% in men or women older than 65 years). condition as an inclusion criterion.
Lipska et al also found a high percentage of patients (62%) In summary, the results of this pooled analysis show that
with a tight glycaemic control (HbA1c ≤7%) among US older the glycaemic control and therapeutic management of older
adults with diabetes (8). Furthermore, another study conducted patients with type 2 DM in Spain is inadequate, mainly due
in French long-term-care homes also reported a tight glycaemic to overtreatment with drugs with high risk of hypoglycaemia.
control in elderly patients with diabetes. In particular, they These findings emphasise the need for better management of
described a total of 32% of subjects with an HbA1c value of type 2 DM in older adults and for changing the targets now
≤6.5% (16). recommended by several local guidelines of practice.
Antidiabetic therapies such as sulphonylureas or human
insulin are not recommended in the elderly (4, 7, 17). However, Key conclusions
a large proportion of older patients with type 2 DM were
receiving sulphonylureas (65%) or insulin (30%) despite the • The glycaemic control of older patients with type 2 DM in
associated risk of hypoglycaemia (by comparison 27% were Spain is inadequate
receiving thiazolidinediones, 9% received alpha-glucosidase • Patients are overtreated with drugs with high risk of
inhibitors , and 9% glucagon-like peptide 1 [GLP-1] receptor hypoglycaemia
agonists). Aside from this, half of the patients were on free or • There is a need for better management of type 2 DM in
fixed-dose OAD combinations. These treatment patterns were older adults in Spain
generally consistent with previous studies that reported a high
percentage of older diabetic adults receiving insulin (between Acknowledgements: Manuscript writing and editorial support was provided by Eva
Mateu from TFS Develop.
27-34%) or sulphonylureas (40-56%) (8, 18). Conversely, the
proportion of patients who were prescribed DPP4 inhibitors, a Funding: Financial support was provided by Novartis Farmacéutica, S.A., Barcelona,
Spain.
glucose-lowering agent with a low risk of hypoglycaemia, was
higher in our European sample compared to older US patients Conflict of interest: Dr. Francesc Formiga has received speaking and/or advisory board
honoraria from Boehringer-Ingelheim and Lilly, Glaxo SmithKline, Jansen, Novartis and
with type 2 DM (56% vs. 12%) (18). Novo Nordisk. Dr. Josep Franch-Nadal has received speaking and/or advisory board
In our sample, there was a high rate of hypertension and honoraria related to this subject from Novartis, Boehringer-Ingelheim and Lilly, MSD
dyslipidaemia, common comorbidities among older adults and Jansen. Dr. Leocadio Rodríguez has received grants from Novartis, Lilly, Servier
and Sanofi for making research projects or for giving lectures. Dr. Luis Ávila Lachica has
with diabetes (3). According to current IDF guidelines (1), the received honoraria for collaboration with this subject from Novartis, Novo, Boehringer-
LDL-cholesterol level was clearly outside the target (<80 mg/ Ingelheim, Lilly, MSD, Janssen, Astra Médica, Esteve, Servier and Glaxo. Dr. Eva Fuster
is employee of Novartis.
dl) regardless of lipid-lowering medications. The prevalence
of some microvascular and macrovascular complications was Ethical standard: This study was conducted in accordance with the guidelines in
the Declaration of Helsinki and the three studies were reviewed and approved by the
higher in this study than that reported by Souza et al (19) ethics committee at Hospital Clínic of Barcelona (Spain). All study participants provided
among Brazilian older patients with type 2 DM: nephropathy informed written consent prior to study enrolment.
24% versus 13%, retinopathy 19% versus 12%, coronary artery

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