Scholarly article on topic ' Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Yanbu cohort of the A 1 chieve study '

Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Yanbu cohort of the A 1 chieve study Academic research paper on "Medical engineering"

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Academic research paper on topic " Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Yanbu cohort of the A 1 chieve study "

Original Article

Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Yanbu cohort of the A1chieve study

Moody El Harby, Ahmed Saeed1

Department of Diabetic Centre, King Fahd Hospital, Madina, 'Department: Internal Medicine, El Amal Polyclinic, Yanbu, Saudi Arabia

abstract

Background: The Achieve, 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 Yanbu, Saudi Arabia. Results: A total of 499 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 = 256), insulin detemir (n = 146), insulin aspart (n = 3), basal insulin plus insulin aspart (n = 55) and other insulin combinations (n = 37). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.4%) and insulin user (mean HbA1c: 9.5%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA1c (insulin naïve: -2.1%, insulin users: -1.8%). SADRs including major hypoglycaemic events did not occur in 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, Saudi Arabia, Yanbu

Introduction

Diabetes prevalence in Saudi Arabia is estimated to be 16.2%, affecting 2.7 million people.[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, 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 Yanbu, Saudi Arabia.

Materials and Methods

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

Results

A total of 499 patients were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-naive and insulin users is shown in the Table 1. Glycaemic control at baseline was poor in this population. The majority of patients (51.3%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 146), insulin aspart (n = 3), basal insulin plus insulin aspart (n = 55) and other insulin combinations (n = 37).

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Corresponding Author: Moody El Harby, King Fahd Hospital, Madina, Saudia Arabia. E-mail: dr_lolo_123@hotmail.com

After 24 weeks of treatment, overall hypoglycaemia reduced from 16.3 to 7.2 events/patient-year in insulin user group whereas hypoglycaemic events increased from 0.9 to 2.0 events/patient-year in the insulin naïve group.

Number of participants 313 186 499

Male N (%) 205 (66.6) 112 (61.9) 317 (64.8)

Female N (%) 103 (33.4) 69 (38.1) 172 (35.2)

Age (years) 50.3 52.3 51.0

Weight (kg) 84.2 84.8 84.4

BMI (kg/m2) 30.9 30.5 30.7

Duration of DM (years) 8.9 14.2 10.8

No therapy 6

>2 OGLD 20 11 31

HbA,c 9.4 9.5 9.4

FPG (mmol/L) 11.2 11.2 11.2

PPPG (mmol/L) 14.8 13.9 14.5

Macrovascular 81 (25.9) 90 (48.4) 171 (34.3)

complications, N (%)

Microvascular 209 (66.8) 166 (89.2) 375 (75.2)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 186 (37.3)

OGLD only 307 (61.5)

No therapy 6 (1.2)

Baseline therapy, N (%)

Insulin detemir±OGLD 146 (29.3)

Insulin aspart±OGLD 3 (0.6)

Basal+insulin aspart±OGLD 55 (11.0)

Biphasic insulin aspart±OGLD 256 (51.3)

Others 37 (7.4)

Missing 2 (0.4)

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

However, this hypoglycaemia incidence in insulin naive group at 24 weeks was still lower than that observed in insulin users at baseline. SADRs including major hypoglycaemic events did not occur in the study patients. Body weight and blood pressure decreased from baseline, while overall lipid profile improved at week 24 in complete cohort [Tables 2 and 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, 256 patients started on biphasic insulin aspart ± OGLD, 153 (59.7%) were insulin naïve and 103 (40.3%) were insulin users. After 24 weeks of treatment, hypoglycaemic events or episodes increased for both the groups (insulin naïve: from 0.3 to 2.3 events/patient-year; insulin users: from 6.9 to 7.1 events/patient-year). Body weight decreased in both insulin naïve and user groups after 24 weeks [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, 55 patients started on basal + insulin aspart ± OGLD, of which 17 (30.9%) were insulin naïve and 38 (69.1%) were insulin users. After 24 weeks, hypoglycaemic events reduced from 42.1 to 5.5 events/ patient-year in insulin user group whereas hypoglycaemia

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/patient-year

All 313 0.9 2.0 1.1

Nocturnal 0.2 0.4 0.2

Major 0.1 0.0 -0.1

Hypoglycaemia (insulin users), events/patient-year

All 186 16.3 7.2 -9.1

Nocturnal 5.8 3.1 -2.7

Major 3.4 0.0 -3.4

Body weight, kg

Insulin naïve 313 83.7 81.7 -2.0

Insulin users 186 84.6 82.9 -1.7

Lipids and BP (insulin naïve)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 241 3.1 (50, 20.7) 2.4 (140, 58.3) -0.7

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 239 1.0 (142, 59.4) 1.1 (191, 78.6) 0.1

TG, mean (mmol/L), (N, % <2.3 mmol/L) 278 2.4 (168, 60.4) 1.7 (250, 90.6) -0.6

SBP, mean (mmHg), (N, % <130 mmHg) 312 136.9 (85, 27.2) 124.9 (171, 58.6) -12.0

Lipids and BP (insulin users)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 138 3.0 (40, 29.0) 2.7 (69, 43.9) -0.4

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 139 1.0 (79, 56.8) 1.1 (94, 59.9) 0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 160 2.2 (94, 58.8) 1.9 (142, 88.2) -0.3

SBP, mean (mmHg), (N, % <130 mmHg) 184 142.8 (31, 16.8) 131.9 (47, 27.2) -10.9

BP: Blood pressure, LDL-C: Low-density lipoprotein cholesterol, HDL-C: High-density lipoprotein cholesterol, TG: Triglycerides, SBP: Systolic blood pressure

increased from 0.0 to 2.4 events/patient-year in insulin naive group [Tables 8 and 9 ].

All parameters of glycaemic control improved from baseline to study end in those who started on or were basal + insulin aspart ± OGLDs for both insulin naïve and insulin user groups [Table 10].

Insulin detemir ± OGLD

Of the total cohort, 146 patients started on insulin detemir ± OGLD, of which 133 (91.1%) were insulin naïve

Insulin naïve 0 0.0 312 35.5 293 42.8 Insulin users 186 54.8 184 59.6 173 69.8

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 153 0.3 2.3 2.0

Insulin users 103 6.9 7.1 0.2

Body weight, kg

Insulin naïve 148 86.3 84.4 -1.9

Insulin users 97 87.4 84.7 -2.7

Insulin naïve 0 0.0 153 46.2 150 49.5

Insulin users 103 53.1 103 60.9 101 66.6

and 13 (8.9%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 4.0 to 0.0 events/patient-year in insulin users whereas no change in hypoglycaemia was noted in insulin naïve group compared to baseline. Body weight also decreased at the end of the study [Tables 11 and 12].

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 (%) 148 9.3 7.1 -2.2

FPG, mean (mmol/L) 141 11.1 6.4 -4.7

PPPG, mean (mmol/L) 126 15.6 8.4 -7.2

Glycaemic control

(insulin users)

HbA1c, mean (%) 92 9.6 7.6 -1.9

FPG, mean (mmol/L) 88 11.1 7.2 -3.9

PPPG, mean (mmol/L) 64 13.3 8.2 -5.1

HbA,c: Glycated haemoglobin A,c, FPG: Fasting plasma glucose, PPPG: Postprandial plasma glucose

Table 8: Basal+insulin aspart±oral glucose-lowering drug safety data

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia, events/patient-year

Insulin naïve 17 0.0 2.4 2.4

Insulin users 38 42.1 5.5 -36.6

Body weight, kg

Insulin naïve 16 80.7 79.7 -1.0

Insulin users 31 81.8 82.2 0.3

Table 9: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0.0 17 54.9 16 74.1

Insulin users 38 66.9 37 59.0 33 79.4

Table 10: Basal+insulin aspart±oral glucose-lowering drug efficacy data

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA1c, mean (%) 16 10.1 8.0 -2.2

FPG, mean (mmol/L) 16 12.4 7.6 -4.8

PPPG, mean (mmol/L) 16 14.2 9.5 -4.7

Glycaemic control

(insulin users)

HbA1c, mean (%) 32 9.7 7.9 -1.8

FPG, mean (mmol/L) 33 11.1 7.9 -3.2

PPPG, mean (mmol/L) 30 14.3 10.2 -4.1

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

287 9.4 7.4 -2.1

263 11.2 6.8 -4.3

220 14.8 8.7 -6.2

162 9.5 7.7 -1.8

153 11.2 7.4 -3.8

118 13.9 9.0 -4.9

292 40.4

171 25.1

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

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-naive and insulin user groups [Table 13].

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia, events/patient-year

Insulin naïve 133 1.4 1.4 0.0

Insulin users 13 4.0 0.0 -0.4

Body weight, kg

Insulin naïve 112 80.7 78.3 -2.4

Insulin users 12 80.6 79.5 -1.1

Insulin naïve 0 0.0 133 18.9 120 29.0 Insulin users 13 33.2 13 26.5 12 44.6

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA1c, mean (%) 117 9.5 7.6 -1.9

FPG, mean (mmol/L) 101 10.9 7.2 -3.8

PPPG, mean (mmol/L) 75 13.8 8.9 -4.9

Glycaemic control

(insulin users)

HbA1c, mean (%) 12 8.8 7.2 -1.6

FPG, mean (mmol/L) 11 11.3 7.7 -3.6

PPPG, mean (mmol/L) 9 13.8 9.7 -4.1

HbA|c: Glycated haemoglobin A,c, FPG: Fasting plasma glucose, PPPG: Postprandial plasma glucose

Insulin aspart ± OGLD

Of the total cohort, 3 patients started on insulin aspart ± OGLD and all of them were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 30.3 to 0.0 events/patient-year. All parameters of glycaemic control improved from baseline to study end in those who started on or were switched insulin aspart ± OGLDs.

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. Their administration even caused a small weight reduction. SADRs including major hypoglycaemic events did not occur in the study patients. 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 Yanbu, Saudi Arabia.

References

1. IDF Diabetes Atlas. 5th ed. Available from: http://www.idf.org/ atlasmap/atlasmap [Last accessed on 2013 Jun 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.

Cite this article as: El Harby M, Saeed A. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Yanbu cohort of the A1chieve study. Indian J Endocr Metab 2013;17:S441-4.

Source of Support: Nil, Conflict of Interest: None declared.

Table 11: Insulin detemir±oral glucose-lowering drug safety data

Table 12: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Table 13: Insulin detemir±oral glucose-lowering drug efficacy data

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