Original Article

Clinical experience with insulin detemir type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region cohort of the A1chieve study Abdelmjid Chraibi, Ghizlane Belmejdoub1 Department of Endocrinology and Metabolic diseases, Avicenne University Hospital, 1Department of Endocrinology and Diabetology, Military hospital of instruction Mohammed V, Rabat-Sale-Zemmour-Zaer, Morocco

A B S T R A C T 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 Rabat-Sale-Zemmour-Zaer region, Morocco. Results: A total of 424 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 = 177), insulin detemir (n = 150), insulin aspart (n = 11), basal insulin plus insulin aspart (n = 45) and other insulin combinations (n = 41). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 10.1%) and insulin user (mean HbA1c: 9.4%) groups. After 24 weeks of treatment, all the study groups showed improvement in HbA1c (insulin naïve: −2.5%, insulin users: −1.8%). Major hypoglycaemia was observed in the insulin user group after 24 weeks (0.1 events/patient-year). SADRs were reported in 0.5% of insulin users. 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, Rabat-Sale-Zemmour-Zaer, type 2 diabetes mellitus

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] A1chieve, a multinational, Access this article online Quick Response Code: Website: www.ijem.in DOI: 10.4103/2230-8210.122045

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 Rabat-Sale-Zemmour-Zaer region, Morocco.

MATERIALS

AND

METHODS

Please refer to editorial titled: The A1chieve study: Mapping the Ibn Battuta trail..

RESULTS A total of 424 patients were enrolled in the study. The patient characteristics for the entire cohort, divided as insulin-naïve and insulin users are shown in the Table 1. Glycaemic control at baseline was poor in this population. The majority of

Corresponding Author: Prof. Abdelmjid Chraibi, Endocrinology and Metabolic diseases Department, Avicenne University Hospital, Rabat-Sale-Zemmour-Zaer, Morocco. E-mail: [email protected] Indian Journal of Endocrinology and Metabolism / 2013 / Vol 17 / Supplement 2

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Chraibi and Belmejdoub: A1chieve study experience from Rabat-Sale-Zemmour-Zaer, Morocco

patients (41.7%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 150),

insulin aspart (n = 11), basal insulin plus insulin aspart (n = 45) and other insulin combinations (n = 41).

Table 1: Overall demographic data

After 24 weeks of treatment, overall hypoglycaemia reduced from 13.4 events/patient-year to 2.7 events/patient-year in insulin user group while hypoglycaemic events increased from 0.7 events/patient-year to 0.9 events/patient-year in the insulin naïve group. However, this hypoglycaemia incidence in insulin naive group at 24 weeks was still lower than that observed in insulin users at baseline. Major hypoglycaemic events or episodes occurred in the insulin user group. SADRs were reported in 0.5% of insulin users. Blood pressure and quality of life improved after 24 weeks. Although lipid profile improved in the total cohort, but the finding was limited by number of observations [Tables 2 and 3].

Parameters Number of participants Male N (%) Female N (%) Age (years) Weight (kg) BMI (kg/m2) Duration of DM (years) No therapy >2 OGLD HbA1c FPG (mmol/L) PPPG (mmol/L) Macrovascular complications, N (%) Microvascular complications, N (%) Pre-study therapy, N (%) Insulin users OGLD only No therapy Baseline therapy, N (%) Insulin detemir±OGLD Insulin aspart±OGLD Basal+insulin aspart±OGLD Biphasic insulin aspart±OGLD Others Missing

Insulin naïve

Insulin users

All

206 99 (48.1) 107 (51.9) 58.9 72.6 26.8 8.6

218 85 (39.0) 133 (61.0) 58.7 72.7 27.4 12.8

3 10.1 13.3 16.6 29 (14.1)

9.4 11.3 14.8 60 (27.5)

424 184 (43.4) 240 (56.6) 58.8 72.7 27.1 10.8 10 3 9.7 12.3 15.7 89 (21.0)

81 (39.3)

128 (58.7)

209 (49.3)

218 (51.4) 196 (46.2) 10 (2.4) 150 (35.4) 11 (2.6) 45 (10.6) 177 (41.7) 41 (9.7) -

BMI: Body mass index, OGLD: Oral glucose-lowering drug, HbA1c: Glycated hemoglobin A1c, 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]. Biphasic insulin aspart ± OGLD

Of the total cohort, 177 patients started on biphasic insulin aspart ± OGLD, of which 79 (44.6%) were insulin naïve and 98 (55.4%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 8.8 events/patient-year to 3.6 events/patient-year in insulin user group whereas hypoglycaemia increased from 1.3 events/patient-year to 2.2 events/patient-year in insulin naïve group. Quality of life improved at the end of the study [Tables 5 and 6].

Table 2: Overall safety data Parameter Hypoglycaemia (insulin naïve), events/patient-year All Nocturnal Major Hypoglycaemia (insulin users), events/patient-year All Nocturnal Major Body weight, kg Insulin naïve Insulin users Lipids and BP (insulin naïve) LDL-C, mean (mmol/L), (N, % 1.0 mmol/L) TG, mean (mmol/L), (N, %