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

Uday Phadke, Sunil Gupta1, Vaishali Deshmukh2

Ruby Hall Clinic, Pune, 'Sunil's Diabetes Care 'n' Research Centre Pvt. Ltd, Nagpur, 2Deshmukh Clinic and Research Center, Pune, Maharashtra, 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 Maharashtra, India. Results: A total of 3069 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 = 2115), insulin detemir (n = 461), insulin aspart (n = 333), basal insulin plus insulin aspart (n = 92) and other insulin combinations (n = 61). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 8.8) and insulin user (mean HbA1c: 9.1%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: -1.4%, insulin users: -1.4%). 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, Maharashtra, 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 Maharashtra, India.

Materials and Methods

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

Results

A total of 3069 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 (68.92%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 461), insulin aspart (n = 333), basal

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Corresponding Author: Dr. Uday Phadke, Ruby Hall Clinic, Pune, India. E-mail: uday.instride@gmail.com

insulin plus insulin aspart (n — 92) and other insulin combinations (n — 61).

Number of participants 2572 497 3069

Male N (%) 1444 (56.2) 332 (66.9) 1776 (57.9)

Female N (%) 1127 (43.8) 164 (33.1) 1291 (42.1)

Age (years) 51.5 54.4 52.0

Weight (kg) 69.2 70.2 69.4

BMI (kg/m2) 26.7 26.4 26.6

Duration of DM (years) 6.3 10.5 7.0

No therapy 119

>2 OGLD 94 57 151

HbA,c 8.8 9.1 8.9

FPG (mmol/L) 11.5 9.7 11.3

PPPG (mmol/L) 16.8 14.1 16.4

Macrovascular 544 (36.1) 214 (46.4) 758 (38.6)

complications, N (%)

Microvascular 1109 (73.7) 366 (79.4) 1475 (75.0)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 497 (16.19)

OGLD only 2453 (79.93)

No therapy 119 (3.88)

Baseline therapy, N (%)

Insulin detemir±OGLD 461 (15.02)

Insulin aspart±OGLD 333 (10.85)

Basal+insulin aspart±OGLD 92 (3.0)

Biphasic insulin aspart±OGLD 2115 (68.92)

Others 61 (1.99)

Missing 7 (0.23)

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 0.2 events/patient-year to 0.0 events/ patient-year in insulin naive group and from 2.8 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. Blood pressure decreased while overall lipid profile and quality of life improved at week 24 in the total cohort [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, 2115 patients started on biphasic insulin aspart ± OGLD, of which 1845 (87.2%) were insulin naïve and 270 (12.8%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events reduced from 0.2 events/patient-year to 0.0 events/patient-year in insulin naïve group and from 2.2 events/patient-year to 0.1 events/patient-year in insulin users group. Quality of life 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 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/patient-year

All 2572 0.2 0.0 -0.2

Nocturnal 0.1 0.0 -0.1

Major 0.0 0.0 0.0

Hypoglycaemia (insulin users), events/patient-year

All 497 2.8 0.3 -2.5

Nocturnal 1.1 0.1 -1.0

Major 0.7 0.0 -0.7

Body weight, kg

Insulin naïve 2158 69.0 69.1 0.2

Insulin users 374 69.6 69.7 0.1

Lipids and BP (insulin naïve)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 357 2.3 (42, 11.8) 2.4 (8, 47.1) 0.1

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 357 1.1 (303, 84.9) 1.1 (14, 82.4) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 424 1.9 (120, 28.3) 1.8 (14, 82.4) -0.1

SBP, mean (mmHg), (N, % <130 mmHg) 2399 131.5 (813, 33.9) 125.7 (1440, 67.4) -5.8

Lipids and BP (insulin users)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 124 2.7 (42, 33.9) 2.7 (20, 50.0) 0.0

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 123 1.2 (91, 74.0) 1.2 (35, 89.7) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 123 1.7 (93, 75.6) 1.5 (40, 100) -0.1

SBP, mean (mmHg), (N, % <130 mmHg) 483 136.0 (97, 20.1) 131.1 (160, 42.7) -4.9

Quality of life, VAS scale (0-100)

Insulin naïve 2089 42.6 78.4 35.8

Insulin users 351 50.3 75.7 25.4

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, 92 patients started on basal + insulin aspart ± OGLD, of which 41 (44.6%) were insulin naive and 51 (55.4%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart, hypoglycaemic events reduced from 0.8 events/ patient-year to 0.0 events/patient-year in insulin user group, while hypoglycaemia was nil in insulin naive

Insulin naïve 0 0.0 2565 25.1 2328 24.2 Insulin users 497 28.4 497 28.4 423 26.9

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA1c, mean (%) 1877 8.8 7.4 -1.5

FPG, mean (mmol/L) 2156 11.5 7.0 -4.5

PPPG, mean (mmol/L) 1433 16.8 9.8 -7.0

Glycaemic control (insulin users)

HbA1c, mean (%) 351 9.1 7.7 -1.4

FPG, mean (mmol/L) 331 9.7 7.1 -2.6

PPPG, mean (mmol/L) 239 14.1 10.1 -4.0

Achievement of HbA,c <7.0% at week 24 Insulin naïve 2162 15.7%»

(% of patients)

Insulin users 388 12.9%»

(% of patients)

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

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia, events/patient-year

Insulin naïve 1845 0.2 0.0 -0.2

Insulin users 270 2.2 0.1 -2.1

Body weight, kg

Insulin naïve 1586 68.5 68.8 0.3

Insulin users 209 68.8 69.0 0.2

Quality of life,

VAS scale (0-100)

Insulin naïve 1546 42.4 78.4 36.0

Insulin users 215 49.7 76.1 26.3

VAS: Visual analogue scale

Insulin naïve 0 0.0 1845 25.2 1683 25.1 Insulin users 270 28.4 270 28.1 239 28.1

group, similar to baseline. Quality of life improved after 24 weeks of treatment [Table 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, 461 patients started on insulin detemir ± OGLD, of which 399 (86.6%) were insulin naïve and 62 (13.4%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 0.2 events/patient-year to 0.0 events/ patient-year in insulin naïve group and from 2.7 events/ patient-year to 0.0 events/patient-year in insulin users. Body weight decreased and quality of life improved at 24 weeks [Table 11 and 12].

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 (%) 1360 8.8 7.4 -1.5

FPG, mean (mmol/L) 1563 11.6 7.0 -4.6

PPPG, mean (mmol/L) 1037 16.7 9.6 -7.1

Glycaemic control

(insulin users)

HbA1c, mean (%) 194 9.1 7.7 -1.4

FPG, mean (mmol/L) 184 9.7 7.2 -2.5

PPPG, mean (mmol/L) 140 14.2 9.9 -4.3

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 41 0.0 0.0 0.0

Insulin users 51 0.8 0.0 -0.8

Body weight, kg

Insulin naïve 36 68.9 69.4 0.5

Insulin users 41 71.0 71.4 0.4

Quality of life,

VAS scale (0-100)

Insulin naïve 35 43.5 78.0 34.5

Insulin users 33 45.7 75.5 29.8

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 41 44.1 38 30.0

Insulin users 51 32.2 51 39.2 43 31.5

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

Table 6: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

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

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA,c, mean (%) 35 9.3 8.3 -1.0

FPG, mean (mmol/L) 35 12.6 8.5 -4.2

PPPG, mean (mmol/L) 29 18.5 12.4 -6.1

Glycaemic control

(insulin users)

HbA1c, mean (%) 37 8.9 7.7 -1.2

FPG, mean (mmol/L) 29 10.0 6.4 -3.6

PPPG, mean (mmol/L) 11 15.6 10.7 -4.9

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 399 0.2 0.0 -0.2

Insulin users 62 2.7 0.0 -2.7

Body weight, kg

Insulin naïve 330 71.2 71.1 -0.1

Insulin users 32 71.5 71.2 -0.3

Quality of life,

VAS scale (0-100)

Insulin naïve 317 41.3 79.2 37.9

Insulin users 32 54.2 75.3 21.1

VAS: Visual analogue scale

Insulin naïve 0 0.0 399 19.0 358 19.3 Insulin users 62 20.9 62 15.5 42 16.5

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA1c, mean (%) 282 8.9 7.3 -1.5

FPG, mean (mmol/L) 338 11.6 6.8 -4.8

PPPG, mean (mmol/L) 198 17.0 9.5 -7.5

Glycaemic control

(insulin users)

HbA1c, mean (%) 31 9.2 7.5 -1.7

FPG, mean (mmol/L) 28 9.8 7.1 -2.7

PPPG, mean (mmol/L) 19 13.8 10.5 -3.3

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

insulin detemir ± OGLDs for both insulin-nave and insulin user groups [Table 13].

Insulin aspart ± OGLD

Of the total cohort, 333 patients started on insulin aspart ± OGLD, of which 242 (72.7%) were insulin naïve and 91 (27.3%) were insulin users. After 24 weeks of treatment starting or switching to insulin aspart a decrease in hypoglycaemic events was observed in both insulin naïve (from 0.5 events/patient-year to 0.0 events/patient-year) and insulin user (from 5.6 events/patient-year to 1.5 events/patient-year) groups. A decrease in body weight and improvement in quality of life was observed at the end of the study [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 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. All four insulin regimens showed a decrease in FPG and PPPG; however this improvement was higher in insulin naïve compared to insulin users. SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients. A small weight reduction was noted for insulin detemir and insulin aspart groups. Though

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

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia,

events/patient-year

Insulin naïve 242 0.5 0.0 -0.5

Insulin users 91 5.6 1.5 -4.1

Body weight, kg

Insulin naïve 174 69.3 69.2 -0.1

Insulin users 70 70.4 70.3 -0.1

Quality of life,

VAS scale (0-100)

Insulin naïve 163 45.7 76.8 31.1

Insulin users 62 54.1 74.8 20.7

VAS: Visual analogue scale

Table 15: Insulin dose

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

Insulin naïve 0 0.0 242 28.1 209 24.0

Insulin users 91 28.7 91 28.8 77 25.3

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

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 (%) 169 8.9 7.5 -1.4

FPG, mean (mmol/L) 187 10.6 7.3 -3.3

PPPG, mean (mmol/L) 147 16.6 10.7 -5.9

Glycaemic control

(insulin users)

HbA|c, mean (%) 69 9.3 7.8 -1.5

FPG, mean (mmol/L) 69 9.6 7.4 -2.2

PPPG, mean (mmol/L) 60 13.4 10.4 -3.0

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

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 Maharashtra, 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: Phadke U, Gupta S, Deshmukh V. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Maharashtra cohort of the A1chieve study. Indian J Endocr Metab 2013;17:S511-5. Source of Support: Nil, Conflict of Interest: None declared.

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