Scholarly article on topic ' Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Casablanca 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 Casablanca cohort of the A 1 chieve study Academic research paper on "Economics and business"

0
0
Share paper
OECD Field of science
Keywords
{""}

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 Casablanca 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 Casablanca cohort of the A1chieve study

Ahmed Farouqi, Asmae Chadli

Departments of Diabetes, Endocrinology and Nutrition, Ibnou Rochd University Hospital, Casablanca, Morocco

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 Casablanca, Morocco. Results: A total of 495 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Study patients had started on or were switched to biphasic insulin aspart (n = 231), insulin detemir (n = 151), insulin aspart (n = 19), basal insulin plus insulin aspart (n = 53) and other insulin combinations (n = 41). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 10.2%) and insulin user (mean HbA1c: 9.4%) groups. After 24 weeks of treatment, both groups showed improvement in HbA1c (insulin naïve: -2.3%, insulin users: -1.8%). Major hypoglycaemia was observed in the insulin naïve group after 24 weeks. SADRs were reported in 1.2% of insulin naïve and 2.1% of insulin user groups. Conclusion: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.

Key words: A1chieve study, Casablanca, insulin analogues, type 2 diabetes mellitus

Introduction

Diabetes prevalence in Morocco is estimated to be 6.4%.[1] Fear of hypoglycaemia and gain in body weight are barriers for initiation of insulin therapy.[2] Modern insulin analogues are a convenient new approach or tool to glycaemic control, associated with low number of hypoglycaemia and favourable weight change.[3] 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.[4] This short communication presents the results for patients enrolled from Casablanca, Morocco.

Materials and Methods

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

Results

A total of 495 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 (46.7%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 151), insulin aspart (n = 19), basal insulin plus insulin aspart (n = 53) and other insulin combinations (n = 41).

Access this article online

Quick Response Code: Website: www.ijem.in

DOI: 10.4103/2230-8210.122042

Corresponding Author: Prof. Ahmed Farouqi, Ibnou Rochd University Hospital, Casablanca, Morocco. Email id: afarouqi@fmpc.ac.ma

After 24 weeks of treatment, overall hypoglycaemic events or episodes reduced from 11.7 events/patient-year to

Number of participants 253 242 495

Male N (%) 115 (45.5) 107 (44.2) 222 (44.8)

Female N (%) 138 (54.5) 135 (55.8) 273 (55.2)

Age (years) 57.5 55.5 56.5

Weight (kg) 71.2 75.1 73.1

BMI (kg/m2) 26.3 27.5 26.9

Duration of DM (years) 9.2 13.2 11.2

No therapy 22

>2 OGLD 4 1 5

HbA,c 10.2 9.4 9.9

FPG (mmol/L) 14.3 11.9 13.2

PPPG (mmol/L) 18.5 16.0 17.4

Macrovascular 56 (22.1) 56 (23.1) 112 (22.6)

complications, N (%)

Microvascular 136 (53.8) 133 (55.0) 269 (54.3)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 242 (48.88)

OGLD only 231 (46.66)

No therapy 22 (4.44)

Baseline therapy, N (%)

Insulin detemir±OGLD 151 (30.5)

Insulin aspart±OGLD 19 (3.8)

Basal+insulin aspart±OGLD 53 (10.7)

Biphasic insulin 231(46.7)

aspart±OGLD

Others 41 (8.3)

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

5.0 events/patient-year in insulin user group whereas overall hypoglycaemia increased from 3.5 events/patient-year to 3.8 events/patient-year in the insulin naïve group. However, this hypoglycaemia incidence in insulin naive group at 24 weeks was still lower than that observed in insulin users at baseline. Major hypoglycaemic events or episodes occurred in the insulin naïve group. SADRs were reported in 1.2% of insulin naïve and 2.1% of insulin user groups. Blood pressure and quality of life improved after 24 weeks. Although lipid profile improved in the total cohort, but the finding was 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, 231 patients started on biphasic insulin aspart ± OGLD, of which 121 (52.4%) were insulin naïve and 110 (47.6%) were insulin users. After 24 weeks of treatment, hypoglycaemic events or episodes reduced from 11.1 events/patient-year to 2.9 events/patient-year in insulin user group whereas hypoglycaemia increased from 1.3 events/patient-year to 3.2 events/patient-year in insulin naïve group. Quality of life improved at the end of the study [Tables 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

Hypoglycaemia (insulin naïve), events/participant-year

All 253 3.5 3.8 0.3

Nocturnal 0.9 1.6 0.7

Major 0.7 0.1 -0.6

Hypoglycaemia (insulin users), events/participant-year

All 242 11.7 5 -6.7

Nocturnal 4.7 1.2 -3.5

Major 2.2 0.0 -2.2

Body weight, kg

Insulin naïve 185 70.9 74.3 3.4

Insulin users 166 75.1 76.2 1.1

Lipids and BP (insulin naïve)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 102 3.3 (23, 22.5) 2.6 (22, 40.7) -0.7

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 96 1.2 (73, 76.0) 1.2 (43, 86.0) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 114 1.9 (83, 72.8) 1.6 (55, 88.7) -0.3

SBP, mean (mmHg), (N, % <130 mmHg) 245 135.6 (73, 29.8) 132.0 (68, 35.1) -3.6

Lipids and BP (insulin users)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 105 3.2 (23, 21.9) 2.7 (13, 33.3) -0.5

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 93 1.3 (76, 81.7) 1.4 (36, 94.7) 0.1

TG, mean (mmol/L), (N, % <2.3 mmol/L) 110 1.6 (95, 86.4) 1.6 (37, 90.2) 0.0

SBP, mean (mmHg), (N, % <130 mmHg) 235 133.2 (73, 31.1) 131.0 (63, 35.2) -2.2

Quality of life, VAS scale (0-100)

Insulin naïve 200 62.7 78.3 15.6

Insulin users 179 66.0 77.3 11.3

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, 53 patients started on basal + insulin aspart ± OGLD, of which 10 (18.9%) were insulin naive and 43 (81.1%) were insulin users. After 24 weeks, hypoglycaemic events reduced from 29.9 events/patient-year to 0.0

Insulin naïve 0 0.0 253 28.7 207 34.2 Insulin users 242 41.5 242 42.5 184 49.2

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA1c, mean (%) 124 10.2 7.9 -2.3

FPG, mean (mmol/L) 170 14.3 8.1 -6.2

PPPG, mean (mmol/L) 108 18.5 10.2 -8.3

Glycaemic control (insulin users)

HbA1c, mean (%) 112 9.4 7.6 -1.8

FPG, mean (mmol/L) 139 11.9 7.5 -4.4

PPPG, mean (mmol/L) 87 16.0 10.1 -5.9

Achievement of HbA1c <7.0% at week 24 Insulin naïve 159 21.4

(% of patients)

Insulin users 140 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 121 1.3 3.2 1.9

Insulin users 110 11.1 2.9 -8.2

Body weight, kg

Insulin naïve 86 69.1 74.1 5.0

Insulin users 76 74.8 77.0 2.2

Quality of life,

VAS scale (0-100)

Insulin naïve 92 64.1 81.1 17.0

Insulin users 82 65.6 79.4 13.9

VAS: Visual analogue scale

Insulin naïve 0 0 121 35.3 95 40.2

Insulin users 110 41.8 110 45.0 86 50.1

events/patient-year in insulin naive group and from 14.5 events/patient-year to 8.1 events/patient-year in insulin user group. Quality of life improved after 24 weeks [Tables 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 naive and insulin user groups [Table 10].

Insulin detemir ± OGLD

Of the total cohort, 151 patients started on insulin detemir ± OGLD, of which 111 (73.5%) were insulin naive and 40 (26.5%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemia reduced from 13.7 events/patient-year to 3.7 events/patient-year in insulin user group while hypoglycaemic events increased from 3.9 events/patient-year to 4.7 events/patient-year

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 (%) 51 10.5 7.8 -2.7

FPG, mean (mmol/L) 78 14.4 8.1 -6.3

PPPG, mean (mmol/L) 48 19.4 10.2 -9.2

Glycaemic control (insulin users)

HbA1c, mean (%) 55 9.6 7.6 -2.0

FPG, mean (mmol/L) 67 12.3 7.5 -4.8

PPPG, mean (mmol/L) 43 16.0 10.1 -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 10 29.9 0.0 -29.9

Insulin users 43 14.5 8.1 -6.4

Body weight, kg

Insulin naïve 9 72.7 73.7 1.0

Insulin users 29 77.6 78.3 0.7

Quality of life,

VAS scale (0-100)

Insulin naïve 9 73.3 83.9 10.6

Insulin users 32 70.4 77.2 6.8

VAS: Visual analogue scale

Table 9: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 0 10 42.1 9 49.0

Insulin users 43 47.3 43 54.7 32 59.3

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

in insulin naive group. Quality of life also improved after 24 weeks [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 detemir ± OGLDs for both insulin-naive and insulin user groups [Table 13].

Insulin aspart ± OGLD

Of the total cohort, 19 patients started on insulin aspart ± OGLD and all of them were insulin users. After 24 weeks of treatment, hypoglycaemic events increased from 10.3 events/patient-year to 13.9 events/patient-year. Quality of life improved at 24 weeks [Tables 14 and 15].

All parameters of glycaemic control improved from baseline to study end in those who started on or were switched insulin aspart ± OGLDs for insulin user group [Table 16].

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

Parameter N Baseline Week Change from

24 baseline

Glycaemic control

(insulin naïve)

HbA,c, mean (%) б IG.9 7.3 -З.б

FPG, mean (mmol/L) В 15.9 7.B -B.I

PPPG, mean (mmol/L) б IB.7 B.3 -IG.4

Glycaemic control

(insulin users)

HbA,c, mean (%) tó 9.б 7.б -2.G

FPG, mean (mmol/L) 2В I2.3 В.2 -4.I

PPPG, mean (mmol/L) tó I7.3 9.б -7.7

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

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

Parameter

Baseline

Week 24

Change from baseline

Hypoglycaemia, events/patient-year

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. Major hypoglycaemia was observed in the insulin naive group after 24 weeks. SADRs were reported in 1.2% of insulin naïve and 2.1% of insulin user groups. Overall, increase in weight was noted for both insulin naive and

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

Insulin naïve III 3.9 4.7 G.B

Insulin users 4G I3.7 3.7 -IG.G

Body weight, kg

Insulin naïve В2 73.2 75.2 2.G

Insulin users 3G 75.9 75.I -G.B

Quality of life,

VAS scale (0-100)

Insulin naïve 9I 6G.2 75.2 I5.I

Insulin users 3I бб.б 74.9 В.3

VAS: Visual analogue scale

Table 12: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin naïve 0 G III I8.9 94 25.8

Insulin users 40 29.5 4G 23.G 32 3G.3

Parameter N Baseline Week Change from

24 baseline

Glycaemic control

(insulin naïve)

HbA,c, mean (%) б5 9.9 B.I -I.8

FPG, mean (mmol/L) 77 I3.6 7.9 -5.7

PPPG, mean (mmol/L) 52 I7.B IG.6 -7.2

Glycaemic control

(insulin users)

HbA,c, mean (%) I9 9.I 7.6 -I.5

FPG, mean (mmol/L) 28 IG.G б.9 -3.I

PPPG, mean (mmol/L) I4 I4.I 9.8 -4.3

HbAIc: Glycated haemoglobin AIc, FPG: Fasting plasma glucose,

PPPG: Postprandial plasma glucose

Table 14: Insulin aspart±oral glucose-lowering drug

safety data

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia,

events/patient-year

Insulin users I9 IG.3 I3.9 3.6

Body weight, kg

Insulin users I5 69.8 7G.I 0.3

Quality of life,

VAS scale (0-100)

Insulin users I5 68.I 8G.7 12.6

VAS: Visual analogue scale

Table 15: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin users 19 42.7 I9 I9.9 I5 48.4

Table 16: Insulin aspart±oral glucose-lowering drug

efficacy data

Parameter N Baseline Week Change from

24 baseline

Glycaemic control

(insulin users)

HbA,c, mean (%) II 9.3 7.6 -1.7

FPG, mean (mmol/L) 7 I2.4 7.5 -4.9

PPPG, mean (mmol/L) IG I5.I IG.3 -4.8

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

insulin user groups. 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 Casablanca, Morocco.

References

1. IDF Diabetes Atlas. 5th ed.. 2011. Available from: http://www.idf.org/ atlasmap/atlasmap [Last accessed date 2013 Jun 10].

2. Korytkowski M. When oral agents fail: Practical barriers to

starting insulin. Int J Obes Relat Metab Disord 2002;26 Suppl 3:S18-24.

3. Hirsch IB. Insulin analogues. N Engl J Med 2005;352:174-83.

4. 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: Farouqi A, Chadli A. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Casablanca cohort of the A1chieve study. Indian J Endocr Metab 2013;17:S408-12.

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

Copyright of Indian Journal of Endocrinology & Metabolism is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.