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

Jothydev Kesavadev

Department of Internal Medicine, Jothydev's Diabetes Research, Trivandrum, Kerala, India

abstract

Background: The A1chieve, 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 Trivandrum, India. Results: A total of 528 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 = 392), insulin detemir (n = 65), insulin aspart (n = 70) and other insulin combinations (n = 1). At baseline glycaemic control was poor for both insulin naïve (mean HbAflc: 9.9%) and insulin user (mean HbAflc: 8.1%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbAflc (insulin naïve: -2.4%, insulin users: -1.0%). 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, Trivandrum, 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 Trivandrum, India.

Materials and Methods

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

Results

A total of 528 patients were enrolled in the study. The patient characteristics for the entire cohort divided as insulin-naive and insulin users are shown in the Table 1. Glycaemic control at baseline was poor in this population. The majority of patients (74.2%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 65), insulin aspart (n = 70) and other insulin combinations (n = 1).

After 24 weeks of treatment, overall hypoglycaemic events

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Corresponding Author: Dr. Jothydev Kesavadev, Jothydev's Diabetes Research Trivandrum, Kerala, India. E-mail Id: jothydev@vsnl.com

remained nil in both insulin naive and user group similar to that of baseline. SADRs did not occur in any of the study patients. Blood pressure decreased whereas 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].

Biphasic insulin aspart ± OGLD

Of the total cohort, 392 patients started on biphasic insulin

Number of participants 522 6 528

Male N (%) 313 (60.0) 4 (66.7) 317 (60.0)

Female N (%) 209 (40.0) 2 (33.3) 211 (40.0)

Age (years) 57.3 54.1 57.3

Weight (kg) 68.8 59.8 68.7

BMI (kg/m2) 24.9 23.7 24.9

Duration of DM (years) 5.7 7.9 5.7

No therapy 4

>2 OGLD 9 - 9

HbA,c 9.9 8.1 9.9

FPG (mmol/L) 11.2 8.8 11.2

PPPG (mmol/L) 14.9 14.9

Macrovascular 301 (57.7) - 301 (57.0)

complications, N (%)

Microvascular 398 (76.2) - 398 (75.4)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 6 (1.3)

OGLD only 518 (98.1)

No therapy 4 (0.8)

Baseline therapy, N (%)

Insulin detemir±OGLD 65 (12.3)

Insulin aspart±OGLD 70 (13.3)

Biphasic insulin aspart±OGLD 392 (74.2)

Others 1 (0.2)

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

aspart ± OGLD, of which 387 (98.7%) were insulin naïve and 5 (71.0%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events remained nil in both insulin naïve and user group similar to baseline. A slight increase in body weight was noted for insulin users. 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 switched to biphasic insulin aspart for both insulin naïve and insulin user groups [Table 7].

Insulin detemir ± OGLD

Of the total cohort, 65 patients were started on insulin detemir ± OGLD and all were insulin naive. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events remained nil similar to that of baseline. Body weight decreased and quality of life improved at the end of the study [Tables 8 and 9].

All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to insulin detemir ± OGLDs for insulin-naïve group [Table 10].

Insulin aspart ± OGLD

Of the total cohort, 70 patients started on insulin aspart ± OGLD, of which 69 (98.6%) were insulin naïve and 1 (1.4%) was insulin user. After 24 weeks of starting or switching to insulin aspart, hypoglycaemia was nil in both insulin naïve and insulin user groups similar to baseline. Body weight decreased and quality of life improved after 24 weeks in insulin naïve group [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 aspart ± OGLDs for insulin naïve group [Table 13].

Table 1: Overall demographic data

Parameters Insulin Insulin All

naïve users

Table 2: Overall safety data

Parameter

Baseline

Week 24

Change from baseline

Hypoglycaemia (insulin naïve), events/patient-year

All 522 0.0 0.0 0.0

Hypoglycaemia (insulin users), events/patient-year

All 6 0.0 0.0 0.0

Body weight, kg

Insulin naïve 504 68.9 68.6 -0.3

Insulin users 5 58.8 58.9 0.1

BP (insulin naïve)

SBP, mean (mmHg), (N, % <130 mmHg) 515 159.1 (53, 10.3) 132.2 (177, 34.8) -26.9

BP (insulin users)

SBP, mean (mmHg), (N, % <130 mmHg) 3 123.3 (2, 66.7) 120.0 (6, 100) -3.3

Quality of life, VAS scale (0-100)

Insulin naïve 503 47.1 72.4 25.3

Insulin users 5 48.0 88.0 40.0

BP: Blood pressure, SBP: Systolic blood pressure, VAS: Visual analogue scale

Table 3: Insulin dose

Insulin dose, U/day

N Pre-study N Baseline N Week 24

Insulin naïve Insulin users

0 55.3

24.0 25.2

19.5 26.3

Table 4: Overall efficacy data

Parameter

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)

453 9.9 7.5 -2.4

507 11.2 8.0 -3.2

506 14.9 11.2 -3.7

8.1 7.1 -1.0

8.8 6.1 -2.7

12.3 8.5 -3.8

8.9 33.3

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 N Baseline Week Change from

24 baseline

Hypoglycaemia,

events/patient-year

Insulin naïve 387 0.0 0.0 0.0

Insulin users 5 0.0 0.0 0.0

Body weight, kg

Insulin naïve 374 68.7 68.4 -0.3

Insulin users 5 58.8 58.9 0.1

Quality of life,

VAS scale (0-100)

Insulin naïve 372 46.0 72.4 26.4

Insulin users 4 45.0 87.5 42.5

VAS: Visual analogue scale

Table 6: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0 387 23.3 375 20.1

Insulin users 5 36.4 5 24.2 5 27.6

Conclusion

Our study reports improved glycaemic control (HbA1c, FPG, PPPG) and quality of life following 24 weeks of treatment with any of the insulin analogues (biphasic insulin aspart; insulin detemir; insulin aspart) with or without OGLD. Overall, body weight decreased in insulin

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

Parameter N Baseline Week Change from

24 baseline

Glycaemic control

(insulin naïve)

HbA,c, mean (%) 330 9.8 7.4 -2.5

FPG, mean (mmol/L) 375 10.3 7.4 -2.9

PPPG, mean (mmol/L) 373 13.6 10.4 -3.2

Glycaemic control

(insulin users)

HbA,c, mean (%) 5 8.8 7.6 -1.2

FPG, mean (mmol/L) 5 9.7 6.1 -3.5

PPPG, mean (mmol/L) 5 13.2 8.5 -4.7

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

PPPG: Postprandial plasma glucose

Table 8: Insulin detemir±oral glucose-lowering drug

safety data

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia,

events/patient-year

Insulin naïve 65 0.0 0.0 0.0

Body weight, kg

Insulin naïve 64 72.3 71.8 -0.5

Quality of life,

VAS scale (0-100)

Insulin naïve 63 50.3 72.0 21.7

VAS: Visual analogue scale

Table 9: Insulin dose

Insulin dose, U/day

N Pre-study N Baseline N Week 24

Insulin naïve

Table 10: Insulin detemir±oral glucose-lowering drug efficacy data

Parameter N Baseline Week 24 Change from baseline

Glycaemic control

(insulin naïve)

HbA1c, mean (%) 61 10.2 7.6 -2.5

FPG, mean (mmol/L) 64 11.3 8.1 -3.1

PPPG, mean (mmol/L) 64 14.8 11.1 -3.8

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

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

Parameter

N Baseline Week Change from 24 baseline

Hypoglycaemia, events/patient-year

Insulin naïve 69 0.0 0.0 -0.0

Body weight, kg

Insulin naïve 65 67.1 66.8 -0.3

Quality of life, VAS scale (0-100)

Insulin naïve 67 49.5 7|.9 22.3

VAS: Visual analogue scale

Table 12: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0 69 36.3 68 21.2

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA|c, mean (%) 61 10.5 7.5 -3.0

FPG, mean (mmol/L) 67 16.4 11.1 -5.3

PPPG, mean (mmol/L) 68 21.8 15.6 -6.2

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

naïve group while it increased in insulin users. SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients after 24 week of treatment. 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 Trivandrum, 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: Kesavadev J. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Trivandrum cohort of the A1chieve study. Indian J Endocr Metab 2013;17:S565-8.

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

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

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