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

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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 Saiss 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 Saiss cohort of the A1chieve study

Farida Ajdi

Department of Diabetes, Endocrinology and Nutrition, Hassan II University Hospital, Fes, 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 Saiss, Morocco. Results: A total of 145 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 = 47), insulin detemir (n = 56), insulin aspart (n = 1), basal insulin plus insulin aspart (n = 35) and other insulin combinations (n = 6). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 10.4%) and insulin user (mean HbA1c: 9.8%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA1c (insulin naïve: -2.7%, insulin users: -2.5%). 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, Saiss, 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] 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 Saiss, Morocco.

Materials and Methods

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

Results

A total of 145 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 (38.6%) started on or were switched to insulin detemir. Other groups were biphasic insulin aspart (n = 47), insulin aspart (n = 1), basal insulin plus insulin aspart (n = 35) and other insulin combinations (n = 6).

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Corresponding Author: Prof. Farida Ajdi, Hassan II University Hospital, Fes, Morocco. E-mail: faridaajdi@yahoo.fr

After 24 weeks of treatment, overall hypoglycaemic events or episodes reduced from 23.6 events/patient-year to

Number of participants 92 53 145

Male N (%) 47 (51.1) 29 (54.7) 76 (52.4)

Female N (%) 45 (48.9) 24 (45.3) 69 (47.6)

Age (years) 56.8 52.9 55.3

Weight (kg) 70.3 71.8 70.8

BMI (kg/m2) 26.3 26.0 26.2

Duration of DM (years) 10.0 13.4 11.2

No therapy 22

>2 OGLD 5 1 6

HbA,c 10.4 9.8 10.1

FPG (mmol/L) 13.6 12.9 13.3

PPPG (mmol/L) 15.7 14.8 15.3

Macrovascular 14 (15.2) 12 (22.6) 26 (17.9)

complications, N (%)

Microvascular 31 (33.7) 27 (50.9) 58 (40.0)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 53 (36.6)

OGLD only 70 (48.3)

No therapy 22 (15.2)

Baseline therapy, N (%)

Insulin detemir±OGLD 56 (38.6)

Insulin aspart±OGLD 1 (0.7)

Basal+insulin aspart±OGLD 35 (24.1)

Biphasic insulin 47 (32.4)

aspart±OGLD

Others 6 (4.1)

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

15.7 events/patient-year in insulin user group whereas hypoglycaemia increased from 2.3 events/patient-year to 3.1 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. SADRs including major hypoglycaemia did not occur in any of the study patients. Blood pressure decreased and lipid profile improved in the total cohort, but the findings were limited by number of observations. Quality of life improved after 24 weeks [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, 47 patients started on biphasic insulin aspart ± OGLD, of which 33 (70.2%) were insulin naïve and 14 (29.8%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 30.6 events/patient-year to 22.3 events/patient-year in insulin users while hypoglycaemia increased from 0.0 events/patient-year to 0.8 events/patient-year in insulin naïve group. Quality of life improved at 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].

Table 1: Overall demographic data Parameters Insulin Insulin All

naive users

Table 2: Overall safety data

Parameter N Baseline Week 24 Change from

Hypoglycaemia (insulin naïve), events/participant-year

All 92 2.3 3.1 0.8

Nocturnal 1.1 0.6 -0.5

Major 0.6 0.0 -0.6

Hypoglycaemia (insulin users), events/participant-year

All 53 23.6 15.7 -7.9

Nocturnal 6.9 2.4 -4.5

Major 7.6 0.0 -7.6

Body weight, kg

Insulin naïve 75 70.3 71.5 1.1

Insulin users 47 71.6 72.1 0.5

Lipids and BP (insulin naïve)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 28 3.6 (2, 7.1) 3.4 (2, 12.5) -0.2

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 28 1.1 (21, 75.0) 1.1 (12, 66.7) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 47 1.7 (39, 83.0) 1.7 (27, 93.1) -0.0

SBP, mean (mmHg), (N, % <130 mmHg) 88 138.6 (23, 26.1) 132.6 (25, 31.3) -5.9

Lipids and BP (insulin users)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 20 3.5 (5, 25.0) 3.6 (0.0) 0.1

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 19 1.1 (14, 73.7) 1.1 (9, 90.0) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 32 1.8 (24, 75.0) 1.6 (19, 95.0) -0.3

SBP, mean (mmHg), (N, % <130 mmHg) 50 141.9 (14, 28.0) 133.0 (15, 31.9) -8.9

Quality of life, VAS scale (0-100)

Insulin naïve 78 71.7 83.7 12.0

Insulin users 48 66.5 78.6 12.1

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

Basal + insulin aspart ± OGLD

Of the total cohort, 35 patients started on basal + insulin aspart ± OGLD, of which 10 (28.6%) were insulin naïve and 25 (71.4%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced for both insulin naive and insulin user groups (insulin naive: from 13.0 events/patient-year to 8.7 events/patient-year, insulin user: from 25.0 events/ patient-year to 17.1 events/patient-year). Quality of life improved after 24 weeks [Tables 8 and 9].

Insulin naïve 0 0 92 30.1 81 38.6

Insulin users 53 46.2 53 44.5 48 50.4

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve) HbA|c, mean (%) FPG, mean (mmol/L) PPPG, mean (mmol/L) Glycaemic control (insulin users) HbA|c, mean (%) FPG, mean (mmol/L) PPPG, mean (mmol/L) Achievement of HbA|c <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/participant-year

Insulin naïve 33 0.0 0.8 0.8

Insulin users 14 30.6 22.3 -8.3

Body weight, kg

Insulin naïve 30 69.9 71.8 1.8

Insulin users 14 73.7 75.5 1.8

Quality of life,

VAS scale (0-100)

Insulin naïve 33 74.0 86.1 12.1

Insulin users 14 68.9 79.7 10.8

VAS: Visual analogue scale

Insulin naïve 0 0 33 37.0 33 42.5

Insulin users 14 46.8 14 49.1 14 54.7

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 naive and insulin user groups [Table 10].

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 (%) 7 11.2 8.2 -3.0

FPG, mean (mmol/L) 23 14.3 7.3 -7.0

PPPG, mean (mmol/L) 6 17.9 9.6 -8.3

Glycaemic control

(insulin users)

HbA1c, mean (%) 10 10.1 7.6 -2.5

FPG, mean (mmol/L) 12 12.7 7.1 -5.5

PPPG, mean (mmol/L) 6 17.3 9.2 -8.1

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/participant-year

Insulin naïve 10 13.0 8.7 -4.3

Insulin users 25 25.0 17.1 -7.9

Body weight, kg

Insulin naïve 9 66.3 67.4 1.1

Insulin users 21 68.9 68.5 -0.4

Quality of life,

VAS scale (0-100)

Insulin naïve 9 74.0 80.9 6.9

Insulin users 22 69.2 77.8 8.6

VAS: Visual analogue scale

Table 9: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0 10 46.2 9 60.8

Insulin users 25 51.6 25 49.7 22 55.1

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 (%) 5 12.1 8.1 -3.9

FPG, mean (mmol/L) 6 15.5 7.7 -7.8

PPPG, mean (mmol/L) 5 17.3 10.0 -7.4 Glycaemic control (insulin users)

HbA1c, mean (%) 14 10.0 7.3 -2.6

FPG, mean (mmol/L) 17 12.8 6.5 -6.3

PPPG, mean (mmol/L) 13 13.0 8.7 -4.4

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

44 10.4 7.6 -2.7

58 13.6 7.5 -6.2

33 15.7 9.7 -6.0

33 9.8 7.3 -2.5

37 12.9 6.6 -6.2

23 14.8 8.6 -6.1

61 8.2

43 23.3

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

Table 11: Insulin detemir±oral glucose-lowering drug Table 13: Insulin detemir±oral glucose-lowering drug

safety data efficacy data

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia, events/

participant-year

Insulin naïve 44 1.8 4.0 2.2

Insulin users 12 14.1 6.5 -7.6

Body weight, kg

Insulin naïve 33 72.2 72.7 0.5

Insulin users 10 79.0 78.2 -0.8

Quality of life,

VAS scale (0-100)

Insulin naïve 33 67.2 82.3 15.1

Insulin users 10 60.4 79.1 18.7

VAS: Visual analogue scale

Insulin naïve 0 0 44 18.9 36 27.7

Insulin users 12 38.0 12 29.2 10 32.8

Insulin detemir ± OGLD

Of the total cohort, 56 patients started on insulin detemir ± OGLD, of which 44 (78.6%) were insulin naïve and 12 (21.4%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 14.1 events/patient-year to 6.5 events/patient-year in insulin users while hypoglycaemia increased from 1.8 events/patient-year to 4.0 events/patient-year in insulin naïve group. Quality of life improved after 24 weeks [Tables 11 and 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, only 1 patient started on or switched to insulin aspart ± OGLD and was insulin user.

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA1c, mean (%) 32 9.9 7.4 -2.5

FPG, mean (mmol/L) 28 12.7 7.5 -5.1

PPPG, mean (mmol/L) 21 14.2 9.7 -4.5

Glycaemic control

(insulin users)

HbA1c, mean (%) 7 8.9 7.4 -1.6

FPG, mean (mmol/L) 7 12.0 6.6 -5.4

PPPG, mean (mmol/L) 3 14.3 7.7 -6.5

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

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. Quality of life improved in the total cohort. SADRs including major hypoglycaemia did not occur in any of 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 Saiss, Morocco.

References

1. IDF Diabetes Atlas. 5th ed.. 2011. 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: Ajdi F. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Saiss cohort of the Achieve study. Indian J Endocr Metab 2013;17:S422-5. Source of Support: Nil, Conflict of Interest: None declared.

Table 12: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

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