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| ORIGINAL ARTICLE |
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| Year : 2013 | Volume
: 17
| Issue : 8 | Page : 449-452 |
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Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Southwest Saudi Arabia cohort of the A 1 chieve study
Waffaa Shawkat1, Magdy Abdou2, Nadia Ghannam3, Ashraf Shaaban Mahfouz4
1 Department of Diabetes center, Saudi German hospital, Abha, Southwest Saudi Arabia
2 Department of Internal Medicine, Saudi Airlines Medical Center, Jeddah, Western Saudi Arabia
3 Department of Diabetes center of excellence, International Medical Center, Jeddah, Western Saudi Arabia
4 Ghassan Naguib Pharoun Hospital, Jeddah, Western Saudi Arabia
| Date of Web Publication | 27-Nov-2013 |
Correspondence Address:
Waffaa Shawkat
Saudi German hospital, Abha
Southwest Saudi Arabia
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/2230-8210.122070
 Abstract | | |
Background: The A 1 chieve, 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 southwest Saudi Arabia. Results: A total of 2561 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 = 987), insulin detemir (n = 1121), insulin aspart (n = 21), basal insulin plus insulin aspart (n = 280) and missing or other insulin combinations (n = 152). At baseline glycaemic control was poor for both insulin naïve (mean HbA 1 c: 9.9%) and insulin user (mean HbA 1 c: 9.5%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA 1 c (insulin naïve: −2.5%, insulin users: −2.2%). Major hypoglycaemic events did not occur in any of the study patients. SADRs were reported in 0.1% of insulin naïve and 0.1% of insulin user groups. Conclusion: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia. Keywords: A 1 chieve study, insulin analogues, type 2 diabetes mellitus, Southwest Saudi Arabia
How to cite this article:
Shawkat W, Abdou M, Ghannam N, Mahfouz AS. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Southwest Saudi Arabia cohort of the A 1 chieve study. Indian J Endocr Metab 2013;17, Suppl S2:449-52 |
How to cite this URL:
Shawkat W, Abdou M, Ghannam N, Mahfouz AS. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Southwest Saudi Arabia cohort of the A 1 chieve study. Indian J Endocr Metab [serial online] 2013 [cited 2021 May 13];17, Suppl S2:449-52. Available from: https://www.ijem.in/text.asp?2013/17/8/449/122070 |
| Introduction | |  |
2.7 million people are estimated to have diabetes in Saudi Arabia, with estimated prevalence of 16.2%. [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] A 1 chieve, 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 southwest Saudi Arabia.
| Materials and Methods | | |
Please refer to editorial titled: The A 1 chieve study: Mapping the Ibn Battuta trail.
| Results | | |
A total of 2561 patients were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-naïve and insulin users is shown in the [Table 1]. Glycaemic control at baseline was poor in this population. The majority of patients (43.8%) started on or switched to insulin detemir. Other groups were insulin aspart (n = 21), basal insulin plus insulin aspart (n = 280), Biphasic insulin aspart (n = 121) and other insulin combinations (n = 17).
After 24 weeks of treatment, overall hypoglycaemic events or episodes reduced from 5.3 events/patient-year to 1.9 events/patient-year in insulin user group whereas overall hypoglycaemia increased from 0.8 events/patient-year to 1.8 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 did not occur in any of the study patients. SADRs were reported in 0.1% of insulin naïve and 0.1% of insulin user groups. Body weight decreased at the end of the study. Blood pressure and lipid profile improved after 24 weeks in the total cohort [Table 2] and [Table 3].
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, 987 patients started on biphasic insulin aspart ± OGLD, of which 483 (48.9%) were insulin naïve and 504 (51.1%) were insulin users. After 24 weeks of treatment, hypoglycaemic events or episodes reduced from 4.2 events/patient-year to 1.8 events/patient-year in insulin user group whereas hypoglycaemia increased from 0.8 events/patient-year to 1.7 events/patient-year in insulin naïve group. Body weight decreased at 24 weeks [Table 5] and [Table 6].
All aspects 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]. | Table 7: Biphasic insulin aspart±oral glucose-lowering drug efficacy data
Click here to view |
Basal + insulin aspart ± OGLD
Of the total cohort, 280 patients started on basal + insulin aspart ± OGLD, of which 70 (25%) were insulin naïve and 210 (75%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 1.9 events/patient-year to 1.0 events/patient-year in insulin naïve group and from 6.7 events/patient-year to 2.5 events/patient-year in insulin user group. Body weight decreased after 24 weeks in insulin naïve group [Table 8] and [Table 9].
All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to basal + insulin aspart ± OGLDs for both insulin naïve and insulin user groups [Table 10].
Insulin detemir ± OGLD
Of the total cohort, 1121 patients started on insulin detemir ± OGLD, of which 982 (87.6%) were insulin naïve and 139 (12.4%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemia reduced from 3.6 events/patient-year to 1.3 events/patient-year in insulin user group while hypoglycaemic events increased from 0.7 events/patient-year to 2.1 events/patient-year in insulin naïve group. A slight decrease in body weight was observed for both the groups at the end of 24 weeks [Table 11], [Table 12].
All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to insulin detemir ± OGLDs for both insulin-naïve and insulin user groups [Table 13].
Insulin aspart ± OGLD
Of the total cohort, 21 patients started on insulin aspart ± OGLD of which 17 (80.9%) were insulin naïve and 4 (19.1%) were insulin users. Hypoglycaemia remained nil similar to that of baseline for both the groups. After 24 weeks of treatment, a decrease in body weight was observed in the insulin naïve group [Table 14].
All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to insulin aspart ± OGLDs for insulin naïve group [Table 16].
| Conclusion | | |
Our study reports improved glycaemic control following 24 weeks of treatment with any of the insulin analogues (biphasic insulin aspart; basal + insulin aspart; insulin detemir; insulin aspart) with or without OGLD. Major hypoglycaemic events did not occur in any of the study patients. SADRs were reported in 0.1% of insulin naïve and 0.1% of insulin user groups. A small weight reduction was also observed for the overall 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 southwest Saudi Arabia.
| References | | |
| 1. | IDF Diabetes Atlas. 5 th ed. Available from: http://www.idf.org/atlasmap/atlasmap [Last accessed on 2013 Jun 10]. 
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| 2. | Korytkowski M. When oral agents fail: Practical barriers to starting insulin. Int J Obes Relat Metab Disord 2002;26 Suppl 3:S18-24.
[PUBMED] |
| 3. | Hirsch IB. Insulin analogues. N Engl J Med 2005;352:174-83.
[PUBMED] |
| 4. | Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A 1 chieve 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.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12], [Table 13], [Table 14], [Table 16]
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