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

El Ansari Nawal

Department of Endocrinology and Metabolic diseases, Mohammed VI University Hospital, Marrakech Morocco

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 Marrakech, Morocco. Results: A total of 196 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 = 71), insulin detemir (n = 83), insulin aspart (n = 5), basal insulin plus insulin aspart (n = 14) and other insulin combinations (n = 23). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.3%) and insulin user (mean HbA1c: 9.3%) groups. After 24 weeks of treatment, both the study groups showed improvement in HbA1c (insulin naïve: -2.3%, insulin users: -1.9%). SADR's including major hypoglycaemic events 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, Marrakech, 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 Marrakech, Morocco.

Materials and Methods

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

Results

A total of 196 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 (42.3%) started on or were switched to insulin detemir. Other groups were biphasic insulin aspart (n = 71), insulin aspart (n = 5), basal insulin plus insulin aspart (n = 14) and other insulin combinations (n = 23).

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DOI: 10.4103/2230-8210.122041

Corresponding Author: Prof. Nawal Elansari, Endocrinology and Metabolic diseases Department, Mohammed VI University Hospital, Marrakech, Morocco. E-mail: elansarinawal@yahoo.fr

After 24 weeks of treatment, overall hypoglycaemic events or episodes reduced from 10.3 events/patient-year to 7.2 events/patient-year in insulin user group whereas overall

Number of participants 125 71 196

Male N (%) 50 (40.0) 28 (39.4) 78 (39.8)

Female N (%) 75 (60.0) 43 (60.6) 118 (60.2)

Age (years) 58.2 54.8 57.0

Weight (kg) 73.4 71.2 72.6

BMI (kg/m2) 27.0 26.2 26.7

Duration of DM (years) 8.9 11.2 9.8

No therapy 8

>2 OGLD 1 1

HbA,c 9.3 9.3 9.3

FPG (mmol/L) 12.1 11.2 11.8

PPPG (mmol/L) 13.9 13.9 13.9

Macrovascular 18 (14.4) 12 (16.9) 30 (15.3)

complications, N (%)

Microvascular 39 (31.2) 28 (39.4) 67 (34.2)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 71 (36.2)

OGLD only 117 (59.7)

No therapy 8 (4.0)

Baseline therapy, N (%)

Insulin detemir±OGLD 83 (42.3)

Insulin aspart±OGLD 5 (2.6)

Basal+insulin aspart±OGLD 14 (7.1)

Biphasic insulin aspart±OGLD 71 (36.2)

Others 23 (11.7)

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

hypoglycaemia increased from 0.4 events/patient-year to 2.3 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. SADRs including major hypoglycaemic events did not occur in any of the study patients. Blood pressure decreased from baseline while overall lipid profile and quality of life improved after 24 weeks [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, 71 patients started on biphasic insulin aspart ± OGLD, of which 38 (53.5%) were insulin naïve and 33 (46.5%) were insulin users. After 24 weeks of treatment, hypoglycaemic events or episodes increased for both the groups (insulin naïve: from 0.7 events/ patient-year to 3.7 events/patient-year and insulin users: from 9.1 events/patient-year to 10.0 events/patient-year). An increase in body weight was observed for both the groups. 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 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

Hypoglycaemia (insulin naïve), events/participant-year

All 125 0.4 2.3 1.9

Nocturnal 0.1 1.1 1.0

Major 0.0 0.0 0.0

Hypoglycaemia (insulin users), events/participant-year

All 71 10.3 7.2 -3.1

Nocturnal 4.4 0.8 -3.6

Major 0.7 0.0 -0.7

Body weight, kg

Insulin naïve 99 74.0 75.7 1.8

Insulin users 53 71.5 73.3 1.8

Lipids and BP (insulin naïve)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 70 2.9 (15, 21.4) 2.5 (34, 63.0) -0.4

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 71 1.0 (45, 63.4) 1.1 (34, 61.8) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 77 1.5 (69, 89.6) 1.3 (56, 96.6) -0.3

SBP, mean (mmHg), (N, % <130 mmHg) 120 131.2 (59, 49.2) 128.6 (60, 56.1) -2.6

Lipids and BP (insulin users)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 30 3.3 (12, 40.0) 2.6 (6, 30.0) -0.7

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 29 1.1 (23, 79.3) 1.2 (16, 80.0) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 34 1.6 (32, 94.1) 1.4 (20, 95.2) -0.2

SBP, mean (mmHg), (N, % <130 mmHg) 67 127.4 (33, 49.3) 124.7 (35, 59.3) -2.7

Quality of life, VAS scale (0-100)

Insulin naïve 111 51.7 80.8 29.0

Insulin users 63 55.7 74.4 18.7

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, 14 patients started on or switched to basal + insulin aspart ± OGLD, of which 1 (7.1%) was insulin naïve and 13 (92.9%) were insulin users. After 24 weeks of treatment, hypoglycemia reduced from 11.0 events/participant-year to 0.0 events/ participant-year [Tables 8 and 9].

Insulin naïve 0 0 125 28.0 111 34.5

Insulin users 71 43.2 71 43.4 63 51.8

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA1c, mean (%) 89 9.3 7.1 -2.3

FPG, mean (mmol/L) 86 12.1 6.4 -5.6

PPPG, mean (mmol/L) 59 13.9 8.5 -5.5

Glycaemic control (insulin users)

HbA1c, mean (%) 49 9.3 7.4 -1.9

FPG, mean (mmol/L) 38 11.2 6.7 -4.5

PPPG, mean (mmol/L) 26 13.9 8.8 -5.1

Achievement of HbA1c <7.0% at week 24 Insulin naïve 101 49.5

(% of patients)

Insulin users 59 32.2

(% 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 38 0.7 3.7 3.0

Insulin users 33 9.1 10.0 0.9

Body weight, kg

Insulin naïve 29 70.6 73.9 3.3

Insulin users 25 74.9 76.9 2.0

Quality of life,

VAS scale (0-100)

Insulin naïve 32 53.1 78.9 25.9

Insulin users 30 54.2 74.2 19.9

VAS: Visual analogue scale

Insulin naïve 0 0 38 34.7 32 49.1

Insulin users 33 40.3 33 42.1 30 45.7

All parameters of glycaemic control improved from baseline to study end in those who started on or were switched to basal + insulin aspart ± OGLDs [Table 10].

Insulin detemir ± OGLD

Of the total cohort, 83 patients started on insulin detemir ± OGLD, of which 74 (89.2%) were insulin naïve and 9 (10.8%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events reduced from 2.9 events/patient-year to 1.9 events/

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 (%) 21 10.1 7.5 -2.7

FPG, mean (mmol/L) 21 14.6 6.7 -7.8

PPPG, mean (mmol/L) 16 16.5 8.7 -7.8

Glycaemic control

(insulin users)

HbA1c, mean (%) 19 9.2 7.7 -1.5

FPG, mean (mmol/L) 16 12.5 6.6 -5.8

PPPG, mean (mmol/L) 16 14.5 9.0 -5.5

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 users 13 11.0 0.0 -11.0

Body weight, kg

Insulin users 11 63.5 65.3 1.7

Quality of life, VAS scale (0-100) Insulin users 11 52.2 76.8 24.6

VAS: Visual analogue scale

Table 9: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin users 13 43.6 13 46.1 11 59.1

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 (%) 11 9.9 7.1 -2.8

FPG, mean (mmol/L) 8 10.1 6.3 -3.8

PPPG, mean (mmol/L) 3 16.2 7.7 -8.5

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

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

patient-year in insulin user group while hypoglycaemia increased from 0.4 events/patient-year to 0.6 events/ patient-year in insulin naïve group. Quality of life improved at 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

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia, events/patient-year

Insulin naïve 74 0.4 0.6 0.2

Insulin users 9 2.9 1.9 -1.0

Body weight, kg

Insulin naïve 59 75.1 75.6 0.5

Insulin users 5 72.3 71.8 -0.5

Quality of life,

VAS scale (0-100)

Insulin naïve 67 52.7 81.4 28.7

Insulin users 7 70.6 70.7 0.1

VAS: Visual analogue scale

Insulin naïve 0 0 74 19.4 67 23.7

Insulin users 9 20.4 9 17.6 7 23.1

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA1c, mean (%) 58 9.0 7.0 -2.0

FPG, mean (mmol/L) 55 11.3 6.4 -4.9

PPPG, mean (mmol/L) 34 12.9 8.4 -4.6

Glycaemic control (insulin users)

HbA1c, mean (%) 5 8.2 7.3 -0.9

FPG, mean (mmol/L) 5 10.4 7.3 -3.1

PPPG, mean (mmol/L) 1 15.5 10.0 -5.6

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, 5 patients started on insulin aspart ± OGLD of which 1 (20.0%) was insulin naïve and 4 (80.0%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 6.5 events/patient-year to 4.3 events/patient-year in insulin user group. Mean HbA1c and mean FPG improved from baseline to study end who started on or were switched to insulin aspart ± OGLDs for insulin user group. Quality of life improved in both insulin naïve and insulin user groups.

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. SADR's including major hypoglycaemic events did not occur in any of the study patients. 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 Marrakech, Morocco.

References

1. IDF Diabetes Atlas. 5th ed.. 2011. Available from: http://www.idf. org/atlasmap/atlasmap [Last accessed on 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: Nawal E. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Marrakech cohort of the Achieve study. Indian J Endocr Metab 2013;17:S404-7. Source of Support: Nil, Conflict of Interest: None declared.

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

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