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

Debmalya Sanyal, Debasis Basu1, Mihir Saikia2

KPC Medical College and Hospital, 'Apollo Gleneagles, Sugar and Heart Clinic, Kolkata, West Bengal, 2Dr. Lal Path Lab, Chandmari, Guwahati, Assam, 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 North East, India. Results: A total of 730 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 = 518), insulin detemir (n = 88), insulin aspart (n = 74), basal insulin plus insulin aspart (n = 19) and other insulin combinations (n = 30). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.5%) and insulin users (mean HbA1c: 9.2%) groups. After 24 weeks of treatment, both groups showed improvement in HbA1c (insulin naïve: -1.6%, insulin users: -1.5%). 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, insulin analogues, North East India, 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 North East, India.

Materials and Methods

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

Results

A total of 730 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 (70.96%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 88), insulin aspart (n = 74), basal

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Corresponding Author: Dr. Debmalya Sanyal, KPC Medical College and Hospital, Kolkata, India. E-mail: drdebmalyasanyal@gmail.com

insulin plus insulin aspart (n — 19) and other insulin combinations (n — 30).

Number of participants 505 225 730

Male N (%) 304 (60.2%) 162 (72.0) 466 (63.8)

Female N (%) 201 (39.8%) 63 (28.0) 264 (36.2)

Age (years) 52.4 56.6 53.7

Weight (kg) 63.0 64.1 63.3

BMI (kg/m2) 23.7 23.4 23.6

Duration of DM (years) 6.0 10.0 7.3

No therapy 44

>2 OGLD 12 9 21

HbA,c 9.5 9.2 9.4

FPG (mmol/L) 11.8 10.5 11.4

PPPG (mmol/L) 16.5 14.9 15.6

Macrovascular 36 (7.1) 51 (22.7) 87 (11.9)

complications, N (%)

Microvascular 257 (50.9) 174 (77.3) 431 (59.0)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 225 (30.82)

OGLD only 461 (63.15)

No therapy 44 (6.03)

Baseline therapy, N (%)

Insulin detemir±OGLD 88 (12.05)

Insulin aspart±OGLD 74 (10.14)

Basal+insulin aspart±OGLD 19 (2.60)

Biphasic insulin aspart±OGLD 518 (70.96)

Others 30 (4.11)

Missing 1 (0.14)

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

After 24 weeks of treatment, overall hypoglycaemic events reduced from 0.9 events/patient-year to 0.5 events/patient-year and from 20.5 events/patient-year to 0.7 events/patient-year in insulin users. 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. Blood pressure decreased and overall lipid profile improved in the total cohort, but the findings were limited by number of observations. Quality of life improved at the end of the study [Table 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, 518 patients started on biphasic insulin aspart ± OGLD, of which 365 (70.5%) were insulin naïve and 153 (29.5%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 1.0 events/patient-year to 0.5 events/patient-year in insulin naïve group and from 21.0 events/patient-year to 0.9 events/patient-year in insulin users. Quality of life also improved at the end of the study [Table 5 and 6].

All parameters of glycaemic control improved from baseline to study end in those who started on or were

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 505 0.9 0.5 -0.4

Nocturnal 0.3 0.2 -0.1

Major 0.0 0.0 0.0

Hypoglycaemia (insulin users), events/patient-year

All 225 20.5 0.7 -19.8

Nocturnal 6.8 0.3 -6.5

Major 0.9 0.0 -0.9

Body weight, kg

Insulin naïve 308 62.0 62.1 0.1

Insulin users 138 64.7 65.0 0.3

Lipids and BP (insulin naïve)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 203 2.4 (106, 52.2) 2.3 (49, 77.8) -0.1

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 201 1.2 (163, 81.1) 1.2 (60, 95.2) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 204 1.8 (153, 75.0) 1.5 (55, 91.7) -0.3

SBP, mean (mmHg), (N, % <130 mmHg) 378 133.8 (106, 28.0) 125.6 (128, 68.8) -8.2

Lipids and BP (insulin users)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 103 2.5 (53, 51.5) 2.3 (26, 78.8) -0.2

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 105 1.1 (89, 84.8) 1.2 (31, 91.2) 0.1

TG, mean (mmol/L), (N, % <2.3 mmol/L) 105 1.9 (82, 78.1) 1.6 (29, 90.6) -0.3

SBP, mean (mmHg), (N, % <130 mmHg) 186 130.5 (67, 36.0) 124.8 (64, 63.4) -5.7

Quality of life, VAS scale (0-100)

Insulin naïve 326 57.6 67.6 10.0

Insulin users 141 57.1 67.2 10.1

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

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

Basal + insulin aspart ± OGLD

Of the total cohort, 19 patients on started on basal + insulin aspart ± OGLD, of which 5 (26.3%) were insulin naive and 14 (73.7%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 17.6 events/patient-year to 0.0 events/patient-year in insulin user group, whereas hypoglycaemia remained nil in insulin naive group similar to that of baseline. Body weight increased in insulin naive group whereas it decreased in insulin users. Quality of life improved after 24 weeks of treatment [Table 8 and 9].

Insulin naïve 0 0.0 504 20.2 349 20.8 Insulin users 225 29.9 225 29.6 148 25.4

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin na'i've)

HbA1c, mean (%) 336 9.5 7.9 -1.5

FPG, mean (mmol/L) 347 11.8 5.9 -5.9

PPPG, mean (mmol/L) 16 16.5 8.6 -7.9

Glycaemic control (insulin users)

HbA1c, mean (%) 144 9.2 7.7 -1.5

FPG, mean (mmol/L) 147 10.5 5.6 -4.9

PPPG, mean (mmol/L) 22 14.9 9.0 -6.0

Achievement of HbA1c <7.0% at week 24 Insulin naïve 345 18.0%»

(% of patients)

Insulin users 145 20.7%»

(% 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 365 1.0 0.5 -0.5

Insulin users 153 21.0 0.9 -20.1

Body weight, kg

Insulin naïve 256 61.6 61.9 0.2

Insulin users 109 64.2 64.6 0.4

Quality of life,

VAS scale (0-100)

Insulin naïve 257 57.6 67.7 10.1

Insulin users 110 57.1 67.2 10.1

VAS: Visual analogue scale

Mean HbA1c and FPG values improved from baseline to study end in those who started on or were switched to basal + insulin aspart ± OGLDs for insulin naive group whereas all aspects of glycaemic control improved in the insulin user group [Table 10].

Insulin detemir ± OGLD

Of the total cohort, 88 patients started on insulin detemir ± OGLD, of which 83 (94.3%) were insulin naive and 05 (5.7%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 0.3 events/patient-year to 0.0 events/patient-year in

Table 6: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0.0 365 20.3 275 21.5

Insulin users 153 30.1 153 28.1 117 24.8

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 (%) 264 9.6 7.9 -1.7

FPG, mean (mmol/L) 273 12.2 5.9 -6.3

PPPG, mean (mmol/L) 11 17.3 8.6 -8.7

Glycaemic control

(insulin users)

HbA1c, mean (%) 113 9.3 7.7 -1.7

FPG, mean (mmol/L) 116 10.6 5.7 -4.9

PPPG, mean (mmol/L) 20 15.0 9.1 -5.9

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 5 0.0 0.0 0.0

Insulin users 14 17.6 0.0 -17.6

Body weight, kg

Insulin naïve 2 68.0 69.5 1.5

Insulin users 5 75.9 75.5 -0.4

Quality of life,

VAS scale (0-100)

Insulin naïve 2 57.0 67.5 10.5

Insulin users 6 56.5 69.2 12.7

VAS: Visual analogue scale

Table 9: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin na'i've 0 0.0 5 40.8 2 46.0

Insulin users 14 39.0 14 47.7 6 36.0

Table 3: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Table 4: Overall efficacy data

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

insulin naïve group and from 26.0 events/patient-year to 0.0 events/patient-year in insulin users. Quality of life improved after 24 weeks of treatment [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, 74 patients started on insulin aspart ± OGLD was 74, of which 41 (55.4%) were insulin naïve and 33 (44.6%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 24.0 to 0.0 in insulin users group whereas hypoglycaemia increased from 0.6 events/patient-year to 1.5 events/patient-year in insulin naïve group. Quality of life improved after 24 weeks [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 population while

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 (%) 42 9.0 8.3 -0.7

FPG, mean (mmol/L) 43 10.5 5.7 -4.9

PPPG, mean (mmol/L) 2 14.0 8.9 -5.1

Glycaemic control

(insulin users)

HbA|c, mean (%) 1 9.8 7.2 -2.6

FPG, mean (mmol/L) 1 10.1 5.0 -5.1

PPPG, mean (mmol/L) | 11.8 7.8 -4.0

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

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) PPPG, mean (mmol/L)

2 11.2 8.7 -2.5

2 12.2 5.8 -6.4

6 9.8 8.6 -1.2

6 12.3 5.5 -6.8

1 16.2 7.2 -9.0

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

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

Parameter N Baseline Week 24 Change from baseline

Hypoglycaemia,

events/patient-year

Insulin naïve 41 0.6 1.5 0.9

Insulin users 33 24.0 0.0 -24.0

Body weight, kg

Insulin naïve 20 61.1 61.2 0.2

Insulin users 15 63.5 63.9 0.4

Quality of life,

VAS scale (0-100)

Insulin naïve 24 57.5 67.1 9.6

Insulin users 15 56.4 66.1 9.7

VAS: Visual analogue scale

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

Table 15: Insulin dose

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia,

events/patient-year

Insulin naïve 83 0.3 0.0 -0.3

Insulin users 5 26.0 0.0 -26.0

Body weight, kg

Insulin naïve 29 66.3 64.8 -1.5

Insulin users 1 82.5 83.5 1.0

Quality of life,

VAS scale (0-100)

Insulin naïve 40 57.7 67.6 9.9

Insulin users 1 55.0 66.0 11.0

VAS: Visual analogue scale

Table 12: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0.0 83 14.0 43 14.3

Insulin users 5 17.2 5 15.2 1 20.0

Insulin dose, U/day

N Pre-study N Baseline N Week 24

Insulin naïve Insulin users

0.0 31.2

21.4 25.7

20.2 22.4

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 (%) 25 8.8 8.0 -0.8

FPG, mean (mmol/L) 26 |0.7 5.9 -4.8

PPPG, mean (mmol/L) 3 |5.4 8.5 -6.9

Glycaemic control

(insulin users)

HbA|c, mean (%) |5 8.3 7.4 -0.9

FPG, mean (mmol/L) |5 |0.2 5.5 -4.7

PPPG, mean (mmol/L) |5 8.3 7.4 -0.9

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

mean HbA1c and FPG values improved in the insulin user population [Table 16].

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. SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients. Quality of life improved in biphasic insulin aspart, insulin detemir and insulin aspart groups. Overall, an increase in body weight was noted for both insulin naïve and users group. 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 North East 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: Sanyal D, Basu D, Saikia M. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the North East India cohort of the A1chieve study. Indian J Endocr Metab 2013;17:S506-10.

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

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