Scholarly article on topic ' Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Chennai 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 Chennai 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 Chennai 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 Chennai cohort of the A1chieve study

J. S. Kumar, A. Paneerselvam1

Departments of Medicine, SRM Medical College Research Institute, 'Aruna Diabetes Centre, Chennai, Tamil Nadu, India

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 Chennai, India. Results: A total of 1334 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Patients had started on or were switched to biphasic insulin aspart (n = 983), insulin detemir (n = 205), insulin aspart (n = 42), basal insulin plus insulin aspart (n = 41) and other insulin combinations (n = 63). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.4%) and insulin users (mean HbA1c: 9.3%) groups. After 24 weeks of treatment, both groups showed improvement in HbA1c (insulin naïve: -2.1%, insulin users: -1.9%). SADRs including major hypoglycaemic events or episodes 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, Chennai, insulin analogues, type 2 diabetes mellitus

Introduction

62.4 million Indians were reported to have type 2 diabetes mellitus (T2DM) putting India on the forefront of diabetic epidemic across globe.[1,2] Fear of hypoglycaemia and gain in body weight are barriers for initiation of insulin therapy.[3] Modern insulin analogues are a convenient new approach or tool to glycaemic control, associated with low number of hypoglycaemia and favourable weight change.[4] 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.[5] This short communication presents the results for patients enrolled from Chennai, India.

Materials and Methods

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

Results

A total of 1334 patients were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-naive and insulin users is shown in Table 1. Glycaemic control at baseline was poor in this population. The majority of patients (73.7%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 205), insulin aspart (n = 42), basal insulin plus insulin aspart (n = 41) and other insulin combinations (n = 63).

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Corresponding Author: Dr. J. S. Kumar, SRM Medical College Research Institute, Chennai, India. E-mail: drkumarjs@gmail.com

Kumar and Paneerselvam: A1chieve study experience from Chennai, India

After 24 weeks of treatment, overall hypoglycaemic events reduced in both insulin naïve (from 1.2 events/

Table 1: Overall demographic data

Parameters Insulin Insulin All

naïve users

Number of participants 902 432 1334

Male N (%) 506 (56.1) 250 (58.0) 756 (56.7)

Female N (%) 396 (43.9) 181 (42.0) 577 (43.3)

Age (years) 52.7 56.4 53.9

Weight (kg) 68.7 70.8 69.4

BMI (kg/m2) 25.9 27.4 26.4

Duration of DM (years) 8.3 13.5 10.0

No therapy 55

>2 OGLD 303 168 471

HbA,c 9.4 9.3 9.4

FPG (mmol/L) 10.9 10.8 10.9

PPPG (mmol/L) 16.4 15.8 16.2

Macrovascular 130 (14.6) 100 (23.1) 230 (17.4)

complications, N (%)

Microvascular 571 (64.1) 335 (77.5) 906 (68.5)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 432 (32.4)

OGLD only 847 (63.5)

No therapy 55 (4.1)

Baseline therapy, N (%)

Insulin detemir±OGLD 205 (15.4)

Insulin aspart±OGLD 42 (3.1)

Basal+insulin aspart±OGLD 41 (3.1)

Biphasic insulin aspart±OGLD 983 (73.7)

Others 63 (4.7)

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

patient-year to 0.9 events/patient-year) and insulin user (from 2.9 events/patient-year to 2.5 events/ patient-year groups. 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 or episodes did not occur in any of the study patients. Blood pressure decreased from baseline, while overall lipid profile and quality of life improved at week 24 in the total cohort [Tables 2 and 3].

All parameters of glycaemic control improved from baseline to study end in the total cohort [Table 4]. Approximately 30.0% of patients achieved HbA^ < 7.0% at week 24.

Biphasic insulin aspart ± OGLD

Of the total cohort, 983 patients started on biphasic insulin aspart ± OGLD, of which 683 (69.5%) were insulin naïve and 300 (30.5%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced in both insulin naïve (from 0.9 events/patient-year to 0.8 events/patient-year) and insulin user (from 2.6 events/patient-year to 2.2 events/patient-year) groups. Quality of life also improved by 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

Table 2: Overall safety data

Parameter N Baseline Week 24 Change from

Hypoglycaemia (insulin naïve), events/patient-year

All 902 1.2 0.9 -0.3

Nocturnal 0.2 0.1 -0.1

Major 0.2 0.0 -0.2

Hypoglycaemia (insulin users), events/patient-year

All 432 2.9 2.5 -0.4

Nocturnal 0.5 0.4 -0.1

Major 0.1 0.0 -0.1

Body weight, kg

Insulin naïve 710 68.6 68.9 0.4

Insulin users 351 70.3 70.8 0.5

Lipids and BP (insulin naïve)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 596 3.0 (193, 32.4) 2.6 (206, 45.7) -0.5

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 592 1.0 (314, 53.0) 1.1 (296, 66.1) 0.1

TG, mean (mmol/L), (N, % <2.3 mmol/L) 586 2.0 (414, 70.6) 1.6 (379, 91.3) -0.4

SBP, mean (mmHg), (N, % <130 mmHg) 800 133.7 (260, 32.5) 128.0 (388, 48.1) -5.7

Lipids and BP (insulin users)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 361 2.7 (168, 46.5) 2.4 (163, 61.0) -0.3

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 363 1.0 (197, 54.3) 1.1 (176, 65.9) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 358 2.0 (267, 74.6) 1.7 (232, 88.2) -0.3

SBP, mean (mmHg), (N, % <130 mmHg) 409 137.3 (97, 23.7) 131.3 (124, 31.7) -6.0

Quality of life, VAS scale (0-100)

Insulin naïve 772 66.0 76.4 10.4

Insulin users 402 64.4 77.0 12.6

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

Kumar and Paneerselvam: A1chieve study experience from Chennai, India

switched to biphasic insulin aspart for both insulin naive and insulin user groups [Table 7].

Basal + insulin aspart ± OGLD

Of the total cohort, 41 patients started on basal + insulin aspart ± OGLD, of which 10 (24.4%) were insulin naive and 31 (75.6%) were insulin users. After 24 weeks of

Table 3: Insulin dose

Insulin dose, U/day

N Pre-study N Baseline N Week 24

Insulin naïve Insulin users

0 0 902

432 28.8 (18.8) 432

19.9 (9.3) 833 20.5 (9.3) 31.8 (18.2) 405 28.8 (15.6)

Table 4: Overall efficacy data

Parameter N Baseline Week Change from

24 baseline

Glycaemic control

(insulin naïve)

HbA1c, mean (%) 815 9.4 7.3 -2.1

FPG, mean (mmol/L) 816 10.9 6.7 -4.2

PPPG, mean (mmol/L) 797 16.4 10.0 -6.5

Glycaemic control

(insulin users)

HbA1c, mean (%) 401 9.3 7.4 -1.9

FPG, mean (mmol/L) 393 10.8 6.8 -4.0

PPPG, mean (mmol/L) 394 15.8 10.0 -5.8

Achievement of HbA1c

<7.0% at week 24

Insulin naïve 831 31.3

(% of patients)

Insulin users 401 30.2

(% of patients)

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

treatment, hypoglycaemic events reduced from 2.9 events/ patient-year to 2.4 events/patient-year in insulin user group whereas hypoglycaemia increased from 2.6 events/ patient-year to 3.3 events/patient-year in insulin naïve group. Body weight decreased and quality of life improved after 24 weeks of treatment [Tables 8 and 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, 205 patients started on insulin detemir ± OGLD, of which 167 (81.5%) were insulin naïve and 38 (18.5%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from

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 (%) FPG, mean (mmol/L) PPPG, mean (mmol/L) Glycaemic control (insulin users) HbA1c, mean (%) FPG, mean (mmol/L) PPPG, mean (mmol/L)

605 9.4 7.3 -2.1

612 10.9 6.8 -4.1

593 16.5 10.1 -6.4

278 9.2 7.4 -1.8

274 10.7 6.8 -3.9

276 15.8 10.0 -5.7

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

Table 5: Biphasic insulin aspart±oral glucose-lowering drug safety data

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

Parameter N Baseline Week 24 Change from baseline Parameter N Baseline Week 24 Change from baseline

Hypoglycaemia, events/patient-year Insulin naïve 683 0.9 0.8 -0.1 Hypoglycaemia, events/patient-year Insulin naïve 10 2.6 3.3 0.7

Insulin users 300 2.6 2.2 -0.4 Insulin users 31 2.9 2.4 -0.5

Body weight, kg Insulin naïve 530 68.7 69.1 0.5 Body weight, kg Insulin naïve 4 69.9 69.4 -0.5

Insulin users 243 69.2 69.9 0.7 Insulin users 24 73.5 73.2 -0.2

Quality of life, VAS scale (0-100) Insulin naïve 570 66.1 76.5 10.4 Quality of life, VAS scale (0-100) Insulin naïve 6 65.0 79.5 14.5

Insulin users 278 64.9 76.8 11.9 Insulin users 27 63.3 77.1 13.8

VAS: Visual analogue scale

VAS: Visual analogue scale

Table 6: Insulin dose

Insulin dose, U/day

N Pre-study N Baseline N Week 24

Insulin naïve Insulin users

0 26.1

683 300

20.5 27.2

622 281

21.6 26.7

Table 9: Insulin dose

Insulin dose, U/day

Insulin naïve Insulin users

N Pre-study N Baseline N Week 24

0 45.4

40.4 63.0

36.9 47.3

Kumar and Paneerselvam: A1chieve study experience from Chennai, India

2.6 events/patient-year to 1.0 events/patient-year in insulin naive group whereas hypoglycaemia increased from 1.7 events/patient-year to 2.5 events/patient-year in

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA|c, mean (%) 8 10.0 7.3 -2.6

FPG, mean (mmol/L) 7 13.1 7.0 -6.1

PPPG, mean (mmol/L) 7 19.4 10.4 -9.0 Glycaemic control (insulin users)

HbA|c, mean (%) 27 9.6 7.4 -2.2

FPG, mean (mmol/L) 26 11.9 6.5 -5.4

PPPG, mean (mmol/L) 26 17.1 8.8 -8.3

HbA1c: Glycated haemoglobin A,c, FPG: Fasting plasma glucose, PPPG: Postprandial plasma glucose

Parameter N Baseline Week 24 Change from baseline

Hypoglycaemia,

events/patient-year

Insulin naïve 167 2.6 1.0 -1.6

Insulin users 38 1.7 2.5 0.8

Body weight, kg

Insulin naïve 139 68.6 68.6 0.0

Insulin users 27 69.8 70.2 0.3

Quality of life,

VAS scale (0-100)

Insulin naïve 157 65.6 75.8 10.2

Insulin users 37 63.5 76.2 12.7

VAS: Visual analogue scale

Insulin naïve 0 0 167 13.5 162 14.1

Insulin users 38 18.2 38 14.4 37 16.4

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA|c, mean (%) 162 9.3 7.3 -2.0

FPG, mean (mmol/L) 158 10.9 6.4 -4.5

PPPG, mean (mmol/L) 158 15.7 9.6 -6.1

Glycaemic control

(insulin users)

HbA|c, mean (%) 37 9.0 7.3 -1.7

FPG, mean (mmol/L) 36 9.7 6.7 -3.0

PPPG, mean (mmol/L) 36 13.8 9.9 -3.9

HbA1c: Glycated haemoglobin A1c, FPG: Fasting plasma glucose, PPPG: Postprandial plasma glucose

insulin users. Quality of life improved after 24 weeks of treatment [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, 42 patients started on insulin aspart ± OGLD, of which 29 (69.0%) were insulin naïve and 13 (31.0%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 19.0 events/patient-year to 6.5 events/patient-year in insulin user group whereas hypoglycaemia increased from 0.0 events/patient-year to 0.5 events/patient-year in insulin naïve group. Body weight decreased and quality of life improved after 24 weeks of treatment [Tables 14 and 15].

All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to insulin aspart ± OGLDs for both insulin naïve and insulin user groups [Table 16].

Conclusion

Our study reports improved glycaemic control and quality of life 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. SADRs including major

Table 14: Insulin aspart±oral glucose-lowering drug safety data

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia,

events/patient-year

Insulin naïve 29 0.0 0.5 0.5

Insulin users 13 19.0 6.5 12.5

Body weight, kg

Insulin naïve 28 66.1 66.0 -0.1

Insulin users 12 76.0 75.2 -0.8

Quality of life,

VAS scale (0-100)

Insulin naïve 27 66.5 78.4 11.9

Insulin users 12 63.5 78.6 15.1

VAS: Visual analogue scale

Table 15: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0.0 29 25.3 29 24.7

Insulin users |3 43.9 13 4|.2 12 32.3

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

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

Kumar and Paneerselvam: A1chieve study experience from Chennai, India

Parameter N Baseline Week 24 Change from baseline

Glycaemic control

(insulin naïve)

HbA1c, mean (%) 28 9.1 7.2 -1.9

FPG, mean (mmol/L) 29 9.3 6.2 -3.1

PPPG, mean (mmol/L) 29 17.2 9.9 -7.2

Glycaemic control

(insulin users)

HbA1c, mean (%) 11 9.4 7.8 -1.6

FPG, mean (mmol/L) 12 11.4 7.0 -4.4

PPPG, mean (mmol/L) 11 14.0 11.1 -2.9

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

hypoglycaemic events or episodes did not occur in any of the study patients. A slight increase in body weight was noted for 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 Chennai, India.

References

1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: Estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27:1047-53.

2. Shetty P Public health: India's diabetes time bomb. Nature 2012;485:S14-6.

3. Korytkowski M. When oral agents fail: Practical barriers to starting insulin. Int J Obes Relat Metab Disord 2002;26 Suppl 3:S18-24.

4. Hirsch IB. Insulin analogues. N Engl J Med 2005;352:174-83.

5. 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: Kumar JS, Paneerselvam A. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Chennai cohort of the A1chieve study. Indian J Endocr Metab 2013;17:S574-8.

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

Table 16: Insulin aspart±oral glucose-lowering drug efficacy data