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

Satinath Mukhopadhyay, Nilanjan Sengupta1, Sujoy Ghosh

IPGME and R and SSKM Hospital, NRS Medical College and Hospital, Kolkata, West Bengal, 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, 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from West Bengal, India. Results: A total of 1133 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 = 897), insulin detemir (n = 94), insulin aspart (n = 90), basal insulin plus insulin aspart (n = 28) and other insulin combinations (n = 19). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 8.5%) and insulin user (mean HbA1c: 8.9%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA1c (insulin naïve: -1.3%, insulin users: -1.6%). 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, insulin analogues, type 2 diabetes mellitus, West Bengal

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

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10.4103/2230-8210.122142

with T2DM (n = 66,726) in routine clinical care.[5] This short communication presents the results for patients enrolled from West Bengal, India.

Materials and Methods

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

Results

A total of 1133 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 (79.2%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 94), insulin aspart (n = 90), basal insulin plus insulin aspart (n = 28) and other insulin combinations (n = 19).

Corresponding Author: Dr. Satinath Mukhopadhyay, IPGME & R and SSKM Hospital, Kolkata, India. E-mail: satinath.mukhopadhyay@gmail.com

Mukhopadhyay, et al.: A1chieve study experience from West Bengal, India

After 24 weeks of treatment, overall hypoglycaemic events reduced from 6.9 events/patient-year to

Table 1: Overall demographic data

Parameters Insulin Insulin All

naïve users

Number of participants 965 168 1133

Male N (%) 603 (62.6) 111 (66.1) 714 (63.1)

Female N (%) 360 (37.4) 57 (33.9) 417 (36.9)

Age (years) 52.3 57.2 53.0

Weight (kg) 65.1 64.8 65.0

BMI (kg/m2) 25.1 25.3 25.1

Duration of DM (years) 6.9 12.3 7.7

No therapy 25

>2 OGLD 35 12 47

HbA,c 8.5 8.9 8.6

FPG (mmol/L) 10.3 10.2 10.3

PPPG (mmol/L) 18.2 19.8 19.1

Macrovascular 311 (32.2) 110 (65.5) 421 (37.2)

complications, N (%)

Microvascular 309 (32.0) 108 (64.3) 417 (36.8)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 168 (14.83)

OGLD only 940 (82.97)

No therapy 25 (2.21)

Baseline therapy, N (%)

Insulin detemir±OGLD 94 (8.30)

Insulin aspart±OGLD 90 (7.94)

Basal+insulin aspart±OGLD 28 (2.47)

Biphasic insulin aspart±OGLD 897 (79.2)

Others 19 (1.68)

Missing 5 (0.44)

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

0.9 events/patient-year in insulin users whereas overall hypoglycaemia increased from 0.2 events/patient-year to 0.7 events/patient-year in insulin naive 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 hypoglycaemic events did not occur in any of the study patients. Blood pressure decreased while overall lipid profile and quality of life improved at week 24 in the total cohort but the findings were limited by number of observations [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, 897 patients started on biphasic insulin aspart ± OGLD, of which 769 (85.7%) were insulin naïve and 128 (14.3%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events decreased from 7.7 events/ patient-year to 1.1 events/patient-year in insulin user group while hypoglycaemia increased from 0.2 events/ patient-year to 0.8 events/patient-year in insulin naive group. A small increase in body weight was observed. Quality of life improved 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

Table 2: Overall safety data

Parameter N Baseline Week 24 Change from

Hypoglycaemia (insulin naive), events/patient-year

All 965 0.2 0.7 0.5

Nocturnal 0.1 0.1 0.0

Major 0.0 0.0 0.0

Hypoglycaemia (insulin users), events/patient-year

All 168 6.9 0.9 -6.0

Nocturnal 1.2 0.0 -1.2

Major 1.7 0.0 -1.7

Body weight, kg

Insulin naive 651 66.0 66.1 0.1

Insulin users 139 65.1 65.3 0.2

Lipids and BP (insulin naive)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 456 3.9 (6, 1.3) 3.7 (14, 6.8) -0.2

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 464 1.0 (223, 48.1) 1.1 (155, 73.8) 0.1

TG, mean (mmol/L), (N, % <2.3 mmol/L) 398 1.9 (328, 82.4) 1.8 (158, 96.9) -0.1

SBP, mean (mmHg), (N, % <130 mmHg) 958 126.7 (472, 49.3) 122.4 (465, 71.1) -4.4

Lipids and BP (insulin users)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 54 3.7 (9, 16.7) 3.3 (15, 36.6) -0.4

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 54 1.0 (29, 53.7) 1.1 (29, 70.7) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 58 2.0 (29, 50.0) 1.6 (25, 92.6) -0.4

SBP, mean (mmHg), (N, % <130 mmHg) 167 137.4 (38, 22.8) 130.0 (57, 40.1) -7.4

Quality of life, VAS scale (0-100)

Insulin naive 31 56.8 67.8 11.0

Insulin users 26 57.8 67.5 9.7

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

Mukhopadhyay, et al.: A1chieve study experience from West Bengal, India

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

Basal + insulin aspart ± OGLD

Of the total cohort, 28 patients started on basal + insulin aspart ± OGLD, of which 15 (53.6%) were insulin naive and 13 (46.4%) were insulin users. After 24 weeks of starting or switching to Biphasic insulin aspart, hypoglycaemic events

Table 3: Insulin dose

Insulin dose, U/day N Pre-study N Baseline N Week 24

Insulin naïve Insulin users 0 168 0.0 29.3 960 168 22.4 32.2 677 26.6 142 35.0

Table 4: Overall efficacy data

Parameter N Baseline Week 24 Change from baseline

remained nil in both insulin user and naïve group similar to that of baseline. Quality of life improved at the end of the 24 weeks [Tables 8 and 9].

Mean HbA1c and FPG value 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 naive and insulin user groups [Table 10].

Table 7: Biphasic insulin aspart±oral glucose-lowering drug efficacy data

Parameter

N Baseline

Week 24

Change from 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)

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)

481 8.6 7.2 -1.4

511 10.3 7.1 -3.2

9 20.2 9.2 -11.0

101 9.0 7.3 -1.6

110 10.0 6.7 -3.4

15 20.1 9.5 -10.6

618 8.5 7.2 -1.3

661 10.3 7.1 -3.3

15 18.2 9.0 -9.3

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

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

130 8.9 7.3 -1.6 drug safety data

139 10.2 6.6 -3.6 Parameter N Baseline Week Change from

17 19.8 9.5 -10.3 24 baseline

29.6 22.1

Hypoglycaemia, events/patient-year

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

Parameter

Baseline

Week 24

Change from baseline

Hypoglycaemia, events/patient-year

Insulin naïve 769 0.2 0.8 0.6

Insulin users 128 7.7 1.1 -6.6

Body weight, kg

Insulin naïve 508 66.4 66.5 0.1

Insulin users 109 64.3 64.6 0.2

Quality of life,

VAS scale (0-100)

Insulin naïve 22 58.4 67.9 9.5

Insulin users 21 57.5 67.5 10

VAS: Visual analogue scale

Table 6: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0.0 769 22.9 526 26.9

Insulin users 128 30.7 128 31.9 111 35.1

Insulin naïve 15 0.0 0.0 0.0

Insulin users 13 0.0 0.0 0.0

Body weight, kg

Insulin naïve 11 65.8 65.7 0.0

Insulin users 9 67.6 66.8 -0.8

Quality of life,

VAS scale (0-100)

Insulin naïve 1 60.0 68.0 8.0

Insulin users 2 57.5 67.5 10.0

VAS: Visual analogue scale

Table 9: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0.0 15 38.7 11 49.7

Insulin users 13 26.4 13 43.8 9 48.0

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

Parameter

N Baseline

Week 24

Change from baseline

Glycaemic control (insulin naïve) HbA|c, mean (%) FPG, mean (mmol/L) Glycaemic control (insulin users) HbA|c, mean (%) FPG, mean (mmol/L)

8.3 10.9

9.4 12.1

7.2 7.2

7.8 6.3

-1.1 -3.7

-1.5 -5.8

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

Mukhopadhyay, et al.: Axhieve study experience from West Bengal, India

Insulin detemir ± OGLD

Of the total cohort, 94 patient started on insulin detemir ± OGLD, of which 82 (87.2%) were insulin naïve and 12 (12.8%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 0.8 events/patient-year to 0.4 events/patient-year in insulin naive group, whereas hypoglycaemia increased from 1.1 events/ patient-year to 1.3 events/patient-year in insulin user group. Quality of life improved after 24 weeks [Table 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, 90 patients started on insulin aspart ± OGLD was 90, of which 85 (94.4%) were insulin naïve

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia,

events/patient-year

Insulin naïve 82 0.8 0.4 -0.4

Insulin users 12 1.1 1.3 0.2

Body weight, kg

Insulin naïve 65 66.6 66.8 0.2

Insulin users 10 68.3 68.8 0.5

Quality of life,

VAS scale (0-100)

Insulin naïve 6 51.3 67.7 16.3

Insulin users 2 60.0 67.5 7.5

VAS: Visual analogue scale

and 5 (5.6%) were insulin users. After 24 weeks of treatment starting or switching to insulin aspart, hypoglycaemic events decreased from 31.1 events/patient-year to 0.0 events/ patient-year in insulin users while hypoglycaemia increased from 0.0 events/patient-year to 0.2 events/patient-year in insulin naive group. An increase in body weight was observed for insulin user group [Table 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 insulin naïve group while mean HbA^ and FPG values improved in the insulin user group [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

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

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia, events/patient-year

Insulin naïve 85 0.0 0.2 0.2

Insulin users 5 31.2 0.0 -31.2

Body weight, kg

Insulin naïve 60 63.6 63.6 0.0

Insulin users 4 63.4 64.2 0.9

Quality of life,

VAS scale (0-100)

Insulin naïve 2 55.0 67.5 12.5

VAS: Visual analogue scale

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

Insulin naïve 0 0.0 82 13.5 71 17.9

Insulin users 12 20.3 12 19.0 10 23.4

Table 15: Insulin dose

Insulin dose, U/day

N Pre-study N Baseline N Week 24

Insulin naïve Insulin users

0.0 24.2

21.7 24.2

28.8 24.0

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

Table 16: Insulin aspart±oral glucose-lowering drug

Parameter N Baseline Week Change from efficacy data

24 baseline Parameter N Baseline Week Change from

Glycaemic control 24 baseline

(insulin naïve) Glycaemic control

HbA1c, mean (%) 64 8.4 7.2 -1.3 (insulin naïve)

FPG, mean (mmol/L) 71 10.5 6.9 -3.6 HbA|c, mean (%) 58 8.2 7.2 -1.1

PPPG, mean (mmol/L) 5 15.9 8.6 -7.3 FPG, mean (mmol/L) 61 9.9 6.9 -2.9

Glycaemic control PPPG, mean (mmol/L) 1 12.3 8.3 -3.9

(insulin users) Glycaemic control

HbA1c, mean (%) 10 8.7 7.1 -1.7 (insulin users)

FPG, mean (mmol/L) 9 11.9 6.3 -5.6 HbA|c, mean (%) 3 8.5 7.1 -1.4

PPPG, mean (mmol/L) 2 17.6 9.3 -8.3 FPG, mean (mmol/L) 3 7.6 6.8 -0.8

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

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

Mukhopadhyay, et al.: A1chieve study experience from West Bengal, India

aspart; insulin detemir; insulin aspart) with or without OGLD. Overall, a small increase in body weight was observed for both insulin naive and users group. SADRs including major hypoglycaemic events or episodes 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 West Bengal, India.

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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: Mukhopadhyay S, Sengupta N, Ghosh S. Clinical

experience with insulin detemir, biphasic insulin aspart and insulin aspart

in people with type 2 diabetes: Results from the West Bengal cohort of the

Achieve study. Indian J Endocr Metab 2013;17:S579-83.

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