0Original Article
Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from North and the oriental region of Morocco cohort of the A1chieve study
Othmane Laaribi
Duc de Tovar Hospital, Tangier, Morocco
abstract
Background: The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66 726) in routine clinical care across four continents. Materials and Methods: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Oriental, Morocco. Results: A total of 180 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Study patients had started on or were switched to biphasic insulin aspart (n = 146), insulin detemir (n = 22), insulin aspart (n = 6), basal insulin plus insulin aspart (n = 2) and other insulin combinations (n = 4). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.0%) and insulin user (mean HbA1c: 8.8%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA1c (insulin naïve: -1.7%, insulin users: -1.6%). SADRs including major hypoglycaemia did not occur in any of the study patients. Conclusion: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.
Key words: A1chieve study, insulin analogues, type 2 diabetes mellitus, Oriental
Introduction
Diabetes prevalence in Morocco is estimated to be 6.4%.[1] Fear of hypoglycaemia and gain in body weight are barriers for initiation of insulin therapy.[2] Modern insulin analogues are a convenient new approach or tool to glycaemic control, associated with low number of hypoglycaemia and favourable weight change.[3] Achieve, a multinational, 24-week, non-interventional study, assessed the safety and effectiveness of insulin analogues in people with T2DM (n = 66,726) in routine clinical care.[4] This short communication presents the results for patients enrolled from Oriental, Morocco.
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10.4103/2230-8210.122047
Materials and Methods
Please refer to editorial titled: The Achieve study: Mapping the Ibn Battuta trail..
Results
A total of 180 patients were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-nai've and insulin users is shown in the Table 1. Glycaemic control at baseline was poor in this population. The majority of patients (81.1%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 22), insulin aspart (n = 6), basal insulin plus insulin aspart (n = 2) and other insulin combinations (n = 4).
After 24 weeks of treatment, overall hypoglycaemia decreased for both insulin user (from 30.1 events/patient-year to 13.8 events/patient-year) and insulin naive (from 24.9 events/patient-year to 12.7 events/patient-year) groups.
Corresponding Author: Dr. Othmane Laaribi, Duc de Tovar Hospital, Tangier, Morocco. E-mail: laaribi@gmail.com
The hypoglycaemia incidence in insulin naive group at 24 weeks was lower than that observed in insulin users at baseline. SADRs including major hypoglycaemic events did not occur in any of the study patients. Also a decrease in body weight was observed for both the groups at 24 weeks [Tables 2 and 3].
Number of patients 113 67 180
Male N (%) 62 (54.9) 38 (56.7) 100 (55.6)
Female N (%) 51 (45.1) 29 (43.3) 80 (44.4)
Age (years) 58.1 52.6 56.0
Weight (kg) 76.2 75.0 75.7
BMI (kg/m2) 27.0 26.6 26.8
Duration of DM (years) 6.5 6.6 6.5
No therapy 1
>2 OGLD 1 - 1
HbA|c 9.0 8.8 8.9
FPG (mmol/L) 11.4 10.6 11.2
PPPG (mmol/L) 15.7 14.5 15.2
Macrovascular 13 (11.5) 9 (13.4) 22 (12.2)
complications, N (%)
Microvascular 25 (22.1) 23 (34.3) 48 (26.7)
complications, N (%)
Pre-study therapy, N (%)
Insulin users 67 (37.2)
OGLD only 112 (62.2)
No therapy 1 (0.6)
Baseline therapy, N (%)
Insulin detemir±OGLD 22 (12.2)
Insulin aspart±OGLD 6 (3.3)
Basal+insulin aspart±OGLD 2 (1.1)
Biphasic insulin aspart±OGLD 146 (81.1)
Others 4 (2.2)
BMI: Body mass index, OGLD: Oral glucose-lowering drug, HbA|c: Glycated hemoglobin A|c, FPG: Fasting plasma glucose, PPPG: Postprandial plasma glucose, DM: Diabetes mellitus
All parameters of glycaemic control improved from baseline to study end in the total cohort [Table 4]. More than 20.0% of patients achieved HbA^ < 7.0% at week 24.
Biphasic insulin aspart ± OGLD
Of the total cohort, 146 patients started on biphasic insulin aspart ± OGLD, of which 95 (65.1%) were insulin naïve and 51 (34.9%) were insulin users. After 24 weeks of treatment, hypoglycaemic events or episodes increased for both the groups (insulin naïve: from 26.4 events/patient-year to 14.7 events/patient-year and insulin users: from 29.6 events/patient-year to 14.1 events/ patient-year). A decrease in body weight was observed for both the groups. Quality of life improved at the end of the study [Tables 5 and 6].
All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to biphasic insulin aspart for both insulin naïve and insulin user groups [Table 7].
Basal + insulin aspart ± OGLD
Of the total cohort, 2 patients started on or were switched to basal + insulin aspart and both of them were insulin users.
Insulin detemir ± OGLD
Of the total cohort, 22 patients started on insulin detemir ± OGLD, of which 17 (77.3%) were insulin naïve and 5 (22.7%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events decreased for both insulin naïve (from
Table 1: Overall demographic data
Parameters Insulin Insulin All
naïve users
Table 2: Overall safety data
Parameter N Baseline Week 24 Change from baseline
Hypoglycaemia (insulin naïve), events/participant-year
All 113 24.9 12.7 -12.2
Nocturnal 12.0 3.1 -8.9
Major 7.4 0.0 -7.4
Hypoglycaemia (insulin users), events/participant-year
All 67 30.1 13.8 -16.3
Nocturnal 13.2 4.8 -8.4
Major 10.7 0.0 -10.7
Body weight, kg
Insulin naïve 91 78.2 76.8 -1.5
Insulin users 51 76.3 75.1 -1.2
Lipids and BP (insulin naïve)
TG, mean (mmol/L), (N, % <2.3 mmol/L) 19 3.0 (12, 63.2) 1.8 (3, 75.0) -1.2
SBP, mean (mmHg), (N, % <130 mmHg) 53 124.0 (19, 35.8) 134.0 (4, 33.3) 10.0
Lipids and BP (insulin users)
TG, mean (mmol/L), (N, % <2.3 mmol/L) 11 1.5 (9, 81.8) 1.5 (2, 100) 0.1
SBP, mean (mmHg), (N, % <130 mmHg) 34 135.0 (8, 23.5) 134.2 (1, 14.3) -0.8
Quality of life, VAS scale (0-100)
Insulin naïve 92 51.1 75.1 24.0
Insulin users 51 51.8 73.4 21.5
BP: Blood pressure, LDL-C: Low-density lipoprotein cholesterol, HDL-C: High-density lipoprotein cholesterol, TG: Triglycerides, SBP: Systolic blood pressure, VAS: Visual analogue scale
0.4 events/patient-year to 0.6 events/patient-year) and insulin user (from 2.9 events/patient-year to 1.9 events/patient-year) group. Quality of life improved at the end of 24 weeks [Tables 8 and 9].
All parameters of glycaemic control improved from baseline to study end in those who started on or were
Insulin naïve 0 0 113 37.7 92 52.4
Insulin users 67 46.8 67 45.8 51 60.9
Parameter N Baseline Week Change from
24 baseline
Glycaemic control (insulin naïve) HbA1c, mean (%) FPG, mean (mmol/L) PPPG, mean (mmol/L) Glycaemic control (insulin users) HbA1c, mean (%) FPG, mean (mmol/L) PPPG, mean (mmol/L) Achievement of HbA1c <7.0% at week 24 Insulin naïve (% of patients) Insulin users (% of patients)
HbA|c: Glycated haemoglobin A,c, FPG: Fasting plasma glucose, PPPG: Postprandial plasma glucose
Parameter N Baseline Week Change from
24 baseline
Hypoglycaemia, events/patient-year
Insulin naïve 95 26.4 14.7 -11.7
Insulin users 51 29.6 14.1 -15.5
Body weight, kg
Insulin naïve 78 78.2 76.6 -1.6
Insulin users 47 76.4 75.1 -1.3
Quality of life,
VAS scale (0-100)
Insulin naïve 78 50.5 74.4 23.8
Insulin users 47 51.1 73.9 22.8
VAS: Visual analogue scale
Insulin naïve 0 0 95 41.8 78 57.4
Insulin users 51 49.3 51 48.1 47 59.8
switched to insulin detemir ± OGLDs for insulin-naïve group [Table 10].
Insulin aspart ± OGLD
Of the total cohort, 6 patients started on insulin aspart ± OGLD of which 1 (16.7%) was insulin naïve and 5 (83.3%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 13.0
Table 7: Biphasic insulin aspart±oral glucose-lowering drug efficacy data
Parameter N Baseline Week Change from
24 baseline
Glycaemic control (insulin naïve)
HbA1c, mean (%) 72 9.0 7.3 -1.7
FPG, mean (mmol/L) 77 11.6 6.5 -5.2
PPPG, mean (mmol/L) 60 16.0 9.3 -6.6
Glycaemic control
(insulin users)
HbA1c, mean (%) 43 8.8 7.2 -1.6
FPG, mean (mmol/L) 44 10.5 6.5 -4.1
PPPG, mean (mmol/L) 36 14.6 9.5 -5.1
HbA,c: Glycated haemoglobin A,c, FPG: Fasting plasma glucose, PPPG: Postprandial plasma glucose
Table 8: Insulin detemir±oral glucose-lowering drug safety data
Parameter N Baseline Week Change from
24 baseline
Hypoglycaemia, events/patient-year
Insulin naïve 17 17.6 2.00 -15.6
Insulin users 5 39.00 0 -39.0
Body weight, kg
Insulin naïve 13 78.5 78.0 -0.5
Quality of life,
VAS scale (0-100)
Insulin naïve 13 55.4 81.8 26.5
VAS: Visual analogue scale
Table 9: Insulin dose
Insulin N Pre-study N Baseline N Week 24
dose, U/day
Insulin naïve 0 0 17 15.3 13 25.1
Insulin users 5 19.8 5 27.6
Table 10: Insulin detemir±oral glucose-lowering drug efficacy data
Parameter N Baseline Week Change from
24 baseline
Glycaemic control (insulin naïve)
HbA1c, mean (%) 12 8.8 7.2 -1.7
FPG, mean (mmol/L) 13 10.6 6.0 -4.6
PPPG, mean (mmol/L) 7 13.3 9.0 -4.3
HbA,c: Glycated haemoglobin A,c, FPG: Fasting plasma glucose, PPPG: Postprandial plasma glucose
Table 3: Insulin dose
Insulin N Pre-study N Baseline N Week 24
dose, U/day
Table 4: Overall efficacy data
84 9.0 7.3 -1.7
91 11.4 6.4 -5.0
67 15.7 9.3 -6.4
45 8.8 7.2 -1.6
48 10.6 6.5 -4.2
39 14.5 9.4 -5.1
84 20.2
45 24.4
Table 5: Biphasic insulin aspart±oral glucose-lowering drug safety data
Table 6: Insulin dose
Insulin N Pre-study N Baseline N Week 24
dose, U/day
events/patient-year to 0.0 events/patient-year for insulin user group [Table1 11 and 12].
Conclusion
Our study reports improved glycaemic control following 24 weeks of treatment with any of the insulin analogues (biphasic insulin aspart; insulin detemir; insulin aspart) with or without OGLD. SADRs including major
Parameter N Baseline Week Change from
24 baseline
Hypoglycaemia, events/patient-year
Insulin users 5 13.0 0.0 -13.0
hypoglycaemia did not occur in any of the study patients. Bodyweight decreased and quality of life improved after 24 weeks in the total cohort. Though the findings are limited by number of patients, still the trend indicates that insulin analogues can be considered effective and possess a safe profile for treating type 2 diabetes in Oriental Morocco.
References
1. IDF Diabetes Atlas. 5th ed.. 2011. Available from: http://www.idf.org/ atlasmap/atlasmap [Last accessed date 2013 June 10].
2. Korytkowski M. When oral agents fail: Practical barriers to starting insulin. Int J Obes Relat Metab Disord 2002;26 Suppl 3:S18-24.
3. Hirsch IB. Insulin analogues. N Engl J Med 2005;352:174-83.
4. Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A1chieve study: A 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice. Diabetes Res Clin Pract 2010;88 Suppl 1:S11-6.
Table 12: Insulin dose
Insulin N Pre-study N Baseline N Week 24
dose, U/day
Cite this article as: Laaribi O. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from North and the oriental region of Morocco cohort of the A1chieve study. Indian J Endocr Metab 2013;17:S418-21.
Source of Support: Nil, Conflict of Interest: None declared.
Table 11: Insulin aspart±oral glucose-lowering drug safety data
Insulin users 5 40.8 5 29.6
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