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

Banshi Saboo, Mayur Patel1

Dia Care - A complete Diabetes Care Centre, 'Swasthya Diabetes Care, Ahmedabad, Gujarat, 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 Gujarat, India. Results: A total of 812 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 = 502), insulin detemir (n = 89), insulin aspart (n = 155), basal insulin plus insulin aspart (n = 45) and other insulin combinations (n = 21). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 8.9%) and insulin user (mean HbA1c: 9.1%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: -2.2%, insulin users: -2.5%). 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, Gujarat, 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 Gujarat, India.

Materials and Methods

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

Results

A total of 812 patients were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-nai've and insulin users is shown in Table 1. Glycaemic control at baseline was poor in this population. The majority of patients (61.82%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 89), insulin aspart (n = 155), basal insulin plus insulin aspart (n = 45) and other insulin combinations (n = 21).

Access this article online

Quick Response Code: Website: www.ijem.in

DOI: 10.4103/2230-8210.122113

Corresponding Author: Dr. Banshi Saboo, Dia Care - A complete Diabetes Care Centre, Ahmedabad, India E-mail: banshisaboo@hotmail.com

After 24 weeks of treatment, overall hypoglycaemia reduced from 0.7 events/patient-year to 0.2 events/

Number of participants 606 206 812

Male N (%) 389 (64.2) 113 (54.9) 502 (61.8)

Female N (%) 217 (35.8) 93 (45.1) 310 (38.2)

Age (years) 54.5 57.3 55.2

Weight (kg) 67.9 68.3 68.0

BMI (kg/m2) 25.9 26.3 26.0

Duration of DM (years) 6.4 10.2 7.4

No therapy 16

>2 OGLD 16 11 27

HbA,c 8.9 9.1 8.9

FPG (mmol/L) 9.8 10.3 9.9

PPPG (mmol/L) - - -

Macrovascular 335 (55.3) 141 (68.4) 476 (58.6)

complications, N (%)

Microvascular 243 (40.1) 122 (59.2) 365 (45.0)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 206 (25.37)

OGLD only 590 (72.66)

No therapy 16 (1.97)

Baseline therapy, N (%)

Insulin detemir±OGLD 89 (10.96)

Insulin aspart±OGLD 155 (19.09)

Basal+insulin aspart±OGLD 45 (5.54)

Biphasic insulin aspart±OGLD 502 (61.82)

Others 21 (2.59)

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 in insulin naïve group and from 1.8 events/patient-year to 0.3 events/patient-year in insulin user group. 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 did not occur in any of the study patients. Body weight and blood pressure decreased from baseline, while overall lipid profile and quality of life improved at week 24 in the total cohort [Table 2 and 3].

Mean HbA1c and FPG values improved from baseline to study end in the total cohort [Table 4].

Biphasic insulin aspart ± OGLD

Of the total cohort, 502 patients started on biphasic insulin aspart ± OGLD, of which 372 (74.1%) were insulin naïve and 130 (25.9%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced for both insulin naive (from 0.9 events/patient-year to 0.3 events/ patient-year) and insulin user (from 1.4 events/patient-year to 0.4 events/patient-year) groups. Body weight decreased and quality of life improved at the end of the study [Table 5 and 6].

Mean HbA1c and FPG values 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

naïve users

Table 2: Overall safety data

Parameter N Baseline Week 24 Change from baseline

Hypoglycaemia (insulin naïve), events/patient-year

All 606 0.7 0.2 -0.5

Nocturnal 0.1 0.1 0.0

Major 0.0 0.0 0.0

Hypoglycaemia (insulin users), events/patient-year

All 206 1.8 0.3 -1.5

Nocturnal 0.7 0.0 -0.7

Major 0.0 0.0 0.0

Body weight, kg

Insulin naïve 436 68.1 67.6 -0.5

Insulin users 157 68.6 67.8 -0.8

Lipids and BP (insulin naïve)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 268 3.9 (24, 9.0) 3.2 (8, 6.6) -0.7

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 269 1.0 (140, 52.0) 1.1 (90, 74.4) 0.1

TG, mean (mmol/L), (N, % <2.3 mmol/L) 264 2.3 (124, 47.0) 2.0 (103, 85.8) -0.3

SBP, mean (mmHg), (N, % <130 mmHg) 606 135.5 (184, 30.4) 123.1 (338, 77.2) -12.3

Lipids and BP (insulin users)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 93 3.7 (7, 7.5%) 2.9 (7, 20.6%) -0.8

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 93 1.0 (48, 51.6) 1.1 (23, 67.6) 0.1

TG, mean (mmol/L), (N, % <2.3 mmol/L) 92 2.2 (46, 50.0) 1.8 (30, 90.9) -0.4

SBP, mean (mmHg), (N, % <130 mmHg) 204 136.7 (55, 27.0) 123.5 (118, 75.2) -13.2

Quality of life, VAS scale (0-100)

Insulin naïve 430 56.8 87.1 30.2

Insulin users 153 57.1 88.2 31.1

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, 45 patients started on basal + insulin aspart ± OGLD, of which 33 (73.3%) were insulin naive and 12 (26.7%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 0.4 events/patient-year to 0.0 events/ patient-year in insulin naive group and from 7.6 events/ patient-year to 0.0 events/patient-year in insulin user group. A decrease in body weight was observed. Quality of life improved at 24 weeks [Table 8 and 9].

Mean HbAjC and FPG values 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].

Insulin detemir ± OGLD

Of the total cohort, 89 patients started on insulin

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

Table 3: Insulin dose 24 baseline

Insulin N Pre-study N Baseline N Week 24 dose, U/day Glycaemic control (insulin na'i've) HbA,c, mean (%) 267 8.9 6.6 -2.3 FPG, mean (mmol/L) 267 9.7 6.1 -3.7 Glycaemic control (insulin users) HbA1c, mean (%) 99 8.9 6.6 -2.3 FPG, mean (mmol/L) 102 10.1 6.4 -3.7

Insulin naive 0 0.0 606 25.4 439 22.1 Insulin users 206 29.8 206 31.6 157 24.3

Table 4: Overall efficacy data

Parameter N Baseline Week Change from 24 baseline HbA1c: Glycated haemoglobin A,c, FPG: Fasting plasma glucose

Glycaemic control (insulin naïve) HbA|c, mean (%) 436 8.9

FPG, mean (mmol/L) 436 9.8 Glycaemic control (insulin users) HbA|c, mean (%) 153 9.1

FPG, mean (mmol/L) 156 10.3 Achievement of HbA|c <7.0% at week 24 Insulin naïve 437 71.2

(% of patients)

Insulin users 153 67.3

(% of patients)

ó.7 ó.I

ó.ó ó.3

-2.2 -3.7

-2.4 -4.0

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

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

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

Parameter

N Baseline Week Change from 24 baseline

Hypoglycaemia, events/patient-year

Insulin naïve 372 0.9 0.3 -0.ó

Insulin users I30 I.4 0.4 -I.0

Body weight, kg

Insulin naïve 2ó8 ó8.4 ó7.9 -0.5

Insulin users I02 óó.5 óó.0 -0.5

Quality of life,

VAS scale (0-100)

Insulin naïve 2ó2 57.I 87.2 30.0

Insulin users I00 5ó.7 88.3 3I.ó

VAS: Visual analogue scale

Table 6: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0.0 372 24.9 2ó9 24.0

Insulin users 130 29.9 I30 3I.0 I02 2ó.ó

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia,

events/patient-year

Insulin naïve 33 0.4 0.0 -0.4

Insulin users I2 7.Ó 0.0 -7.Ó

Body weight, kg

Insulin naïve 3I 79.2 77.7 -I.5

Insulin users 9 78.2 7ó.4 -I.8

Quality of life,

VAS scale (0-100)

Insulin naïve 3I 5ó.5 88.2 3I.ó

Insulin users 9 5ó.I 87.Ó 3I.4

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 33 52.5 3I 22.5

Insulin users 12 3I.Ó I2 50.9 9 27.I

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 (%) 3I 9.I ó.8 -2.3

FPG, mean (mmol/L) 3I 9.8 ó.3 -3.5

Glycaemic control

(insulin users)

HbA1c, mean (%) 9 8.9 ó.9 -2.0

FPG, mean (mmol/L) 9 I0.2 ó.2 -4.0

HhA|c: Glycated haemoglohin A,c, FPG: Fasting plasma glucose

detemir ± OGLD, of which 66 (74.2%) were insulin naïve and 23 (25.8%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart hypoglycaemic events reduced from 0.8 events/patient-year to 0.0 events/ patient-year in insulin naïve group and from 0.6 events/ patient-year to 0.0 events/patient-year in insulin user group. A decrease in body weight was observed. Quality of life improved at 24 weeks [Table 11 and 12].

Mean HbA1c and FPG values 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, 155 patients started on insulin aspart ± OGLD, of which 122 (78.7%) were insulin naïve and 33 (21.3%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 0.1 events/patient-year to 0.0 events/

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

patient-year in insulin naïve group and from 1.6 events/ patient-year to 0.0 events/patient-year in insulin user group. A decrease in body weight was observed. Quality of life improved at 24 weeks [Table 14 and 15].

Mean HbA1c and FPG values 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. A small weight reduction was noted for all the four regimens. 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

Table 14: 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, Hypoglycaemia,

events/patient-year events/patient-year

Insulin naïve 66 0.8 0.0 -0.8 Insulin naïve 122 0.1 0.0 -0.1

Insulin users 23 0.6 0.0 -0.6 Insulin users 33 1.6 0.0 -1.6

Body weight, kg Body weight, kg

Insulin naïve 49 66.9 66.7 -0.2 Insulin naïve 78 63.3 63.1 -0.2

Insulin users 17 74.0 73.2 -0.8 Insulin users 23 71.3 69.8 -1.5

Quality of life, Quality of life,

VAS scale (0-100) VAS scale (0-100)

Insulin naïve 49 55.2 88.2 33.0 Insulin naïve 78 57.0 85.6 28.6

Insulin users 16 57.1 88.9 31.8 Insulin users 22 58.7 87.0 28.3

VAS: Visual analogue scale

VAS: Visual analogue scale

Table 12: Insulin dose

Insulin dose, U/day

N Pre-study N Baseline N Week 24

Insulin naïve Insulin users

0.0 26.3

13.3 13.7

13.5 12.1

Table 15: Insulin dose

Insulin dose, U/day

N Pre-study N Baseline N Week 24

Insulin naïve Insulin users

0.0 31.8

25.5 36.0

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

Parameter

N Baseline Week Change from 24 baseline

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

8.9 9.7

9.2 10.3

6.7 6.2

6.6 6.0

-2.2 -3.5

-2.6 -4.3

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

Parameter

N Baseline Week Change from 24 baseline

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

9.2 10.2

9.9 11.2

6.8 6.1

6.8 6.4

-2.4 -4.1

-3.1 -4.8

HbA1c: Glycated haemoglobin A1c, FPG: Fasting plasma glucose

HbA1c: Glycated haemoglobin A1c, FPG: Fasting plasma glucose

indicates that insulin analogues can be considered effective and possess a safe profile for treating type 2 diabetes in Gujarat, 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: Saboo B, Patel M. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Gujarat cohort of the A1chieve study. Indian J Endocr Metab 2013;17:S521-5.

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

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