Scholarly article on topic ' Clinical experience with insulin detemir type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region cohort of the A 1 chieve study '

Clinical experience with insulin detemir type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region 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 type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region cohort of the A 1 chieve study "

Original Article

Clinical experience with insulin detemir type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region cohort of the A1chieve study

Abdelmjid Chraibi, Ghizlane Belmejdoub1

Department of Endocrinology and Metabolic diseases, Avicenne University Hospital, 'Department of Endocrinology and Diabetology, Military hospital of instruction Mohammed V, Rabat-Sale-Zemmour-Zaer, 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 Rabat-Sale-Zemmour-Zaer region, Morocco. Results: A total of 424 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 = 177), insulin detemir (n = 150), insulin aspart (n = 11), basal insulin plus insulin aspart (n = 45) and other insulin combinations (n=41). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 10.1%) and insulin user (mean HbA1c: 9.4%) groups. After 24 weeks of treatment, all the study groups showed improvement in HbA1c (insulin naïve: -2.5%, insulin users: -1.8%). Major hypoglycaemia was observed in the insulin user group after 24 weeks (0.1 events/patient-year). SADRs were reported in 0.5% of insulin users. 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, Rabat-Sale-Zemmour-Zaer, 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 Rabat-Sale-Zemmour-Zaer region, Morocco.

Materials and Methods

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

Results

A total of 424 patients were enrolled in the study. The patient characteristics for the entire cohort, divided as insulin-naïve and insulin users are shown in the Table 1. Glycaemic control at baseline was poor in this population. The majority of

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10.4103/2230-8210.122045

Corresponding Author: Prof. Abdelmjid Chraibi, Endocrinology and Metabolic diseases Department, Avicenne University Hospital, Rabat-Sale-Zemmour-Zaer, Morocco. E-mail: abdelmjid.chraibi7@gmail.com

patients (41.7%) started on or were switched to biphasic insulin aspart. Other groups were insulin detemir (n = 150),

Table 1: Overall demographic data

Parameters Insulin Insulin All

naïve users

Number of participants 206 218 424

Male N (%) 99 (48.1) 85 (39.0) 184 (43.4)

Female N (%) 107 (51.9) 133 (61.0) 240 (56.6)

Age (years) 58.9 58.7 58.8

Weight (kg) 72.6 72.7 72.7

BMI (kg/m2) 26.8 27.4 27.1

Duration of DM (years) 8.6 12.8 10.8

No therapy 10

>2 OGLD 3 - 3

HbA,c 10.1 9.4 9.7

FPG (mmol/L) 13.3 11.3 12.3

PPPG (mmol/L) 16.6 14.8 15.7

Macrovascular 29 (14.1) 60 (27.5) 89 (21.0)

complications, N (%)

Microvascular 81 (39.3) 128 (58.7) 209 (49.3)

complications, N (%)

Pre-study therapy, N (%)

Insulin users 218 (51.4)

OGLD only 196 (46.2)

No therapy 10 (2.4)

Baseline therapy, N (%)

Insulin detemir±OGLD 150 (35.4)

Insulin aspart±OGLD 11 (2.6)

Basal+insulin aspart±OGLD 45 (10.6)

Biphasic insulin aspart±OGLD 177 (41.7)

Others 41 (9.7)

Missing -

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

insulin aspart (n — 11), basal insulin plus insulin aspart (n — 45) and other insulin combinations (n — 41).

After 24 weeks of treatment, overall hypoglycaemia reduced from 13.4 events/patient-year to 2.7 events/patient-year in insulin user group while hypoglycaemic events increased from 0.7 events/patient-year to 0.9 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 user group. SADRs were reported in 0.5% of insulin users. 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, 177 patients started on biphasic insulin aspart ± OGLD, of which 79 (44.6%) were insulin naïve and 98 (55.4%) were insulin users. After 24 weeks of treatment, hypoglycaemic events reduced from 8.8 events/patient-year to 3.6 events/patient-year in insulin user group whereas hypoglycaemia increased from 1.3 events/patient-year to 2.2 events/patient-year in insulin naïve group. Quality of life improved at the end of the study [Tables 5 and 6].

Table 2: Overall safety data

Parameter N Baseline Week 24 Change from baseline

Hypoglycaemia (insulin naïve), events/patient-year

All 206 0.7 0.9 0.2

Nocturnal 0.3 0.4 0.1

Major 0.2 0.0 -0.2

Hypoglycaemia (insulin users), events/patient-year

All 218 13.4 2.7 -10.7

Nocturnal 4.1 0.8 -3.3

Major 1.3 0.1 -1.2

Body weight, kg

Insulin naïve 160 72.6 73.5 0.9

Insulin users 169 72.4 72.7 0.3

Lipids and BP (insulin naïve)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 101 3.4 (24, 23.8) 3.2 (13, 15.3) -0.2

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 102 1.2 (68, 66.7) 1.2 (59, 72.8) 0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 109 1.9 (90, 82.6) 1.7 (85, 93.4) -0.2

SBP, mean (mmHg), (N, % <130 mmHg) 188 134.7 (60, 31.9) 131.4 (50, 33.3) -3.3

Lipids and BP (insulin users)

LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 112 3.2 (34, 30.4) 3.0 (18, 20.7) -0.2

HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 109 1.2 (78, 71.6) 1.1 (50, 66.7) -0.0

TG, mean (mmol/L), (N, % <2.3 mmol/L) 116 1.6 (101, 87.1) 1.6 (83, 88.3) 0.1

SBP, mean (mmHg), (N, % <130 mmHg) 193 136.7 (53, 27.5) 134.4 (40, 24.7) -2.3

Quality of life, VAS scale (0-100)

Insulin naïve 185 57.2 69.6 12.5

Insulin users 185 60.0 72.3 12.3

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

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].

Basal + insulin aspart ± OGLD

Of the total cohort, 45 patients started on basal + insulin aspart ± OGLD, of which 4 (8.9%) were

Insulin naïve 0 0 206 23.4 186 30.5

Insulin users 218 36.9 217 40.5 187 46.5

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin naïve)

HbA1c, mean (%) 152 10.1 7.6 -2.5

FPG, mean (mmol/L) 140 13.3 7.3 -6.0

PPPG, mean (mmol/L) 87 16.6 9.0 -7.6

Glycaemic control (insulin users)

HbA1c, mean (%) 157 9.4 7.6 -1.8

FPG, mean (mmol/L) 147 11.3 7.6 -3.7

PPPG, mean (mmol/L) 101 14.8 9.2 -5.6

Achievement of HbA1c <7.0% at week 24 Insulin naïve 162 18.5

(% of patients)

Insulin users 171 21.6

(% 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 79 1.3 2.2 0.9

Insulin users 98 8.8 3.6 -5.2

Body weight, kg

Insulin naïve 69 69.8 71.3 1.5

Insulin users 76 73.1 73.4 0.3

Quality of life,

VAS scale (0-100)

Insulin naïve 76 56.3 70.0 13.7

Insulin users 84 60.1 71.4 11.3

VAS: Visual analogue scale

Insulin naïve 0 0 79 33.6 76 40.5

Insulin users 98 36.5 97 40.5 84 45.2

insulin naïve and 41 (91.1%) were insulin users. After 24 weeks, hypoglycaemic events reduced from 36.5 events/patient-year to 3.1 events/patient-year in insulin user group. Quality of life also 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 basal + insulin aspart ± OGLDs [Table 10].

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 (%) 62 10.7 7.6 -3.1

FPG, mean (mmol/L) 61 14.3 7.3 -7.0

PPPG, mean (mmol/L) 39 17.7 8.9 -8.8

Glycaemic control

(insulin users)

HbA1c, mean (%) 63 9.4 7.4 -2.0

FPG, mean (mmol/L) 67 11.1 7.6 -3.5

PPPG, mean (mmol/L) 57 15.9 9.3 -6.6

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 41 36.5 3.1 -33.4

Body weight, kg

Insulin users 38 68.1 68.0 -0.1

Quality of life, VAS scale (0-100)

Insulin users 37 60.2 73.2 13.0

VAS: Visual analogue scale

Table 9: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin users 41 37.7 41 48.7 38 50.8

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

Parameter N Baseline Week Change from

24 baseline

Glycaemic control (insulin users)

HbA1c, mean (%) 35 9.8 7.5 -2.2

FPG, mean (mmol/L) 30 11.1 7.0 -4.1

PPPG, mean (mmol/L) 16 13.9 9.1 -4.8

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

Insulin detemir ± OGLD

Of the total cohort, 150 patients started on insulin detemir ± OGLD, of which 116 (77.3%) were insulin naïve and 34 (22.7%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemia reduced from 13.0 events/patient-year to 0.5 events/patient-year in insulin users and from 0.1 events/patient-year to 0.0 events/patient-year in insulin naïve group. An improvement in quality of life was also observed at the end of the study [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 insulin-naïve group while mean HbA^ and FPG values improved for insulin users [Table 13].

Parameter N Baseline Week 24 Change from baseline

Hypoglycaemia,

events/patient-year

Insulin naïve 116 0.1 0.0 -0.1

Insulin users 34 13.0 0.5 -12.5

Body weight, kg

Insulin naïve 81 75.0 75.3 0.3

Insulin users 21 77.1 77.1 -0.1

Quality of life,

VAS scale (0-100)

Insulin naïve 99 58.6 69.6 11

Insulin users 24 60.8 74.4 13.6

VAS: Visual analogue scale

Insulin naïve 0 0 116 15.1 100 22.0

Insulin users 34 26.7 34 21.1 24 26.6

Parameter N Baseline Week 24 Change from baseline

Glycaemic control

(insulin naïve)

HbA1c, mean (%) 82 9.6 7.6 -1.9

FPG, mean (mmol/L) 70 12.3 7.3 -5.0

PPPG, mean (mmol/L) 43 15.7 9.3 -6.3

Glycaemic control

(insulin users)

HbA1c, mean (%) 22 8.9 7.7 -1.2

FPG, mean (mmol/L) 17 9.5 7.3 -2.1

PPPG, mean (mmol/L) 10 9.7 10.5 0.8

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

Insulin aspart ± OGLD

Of the total cohort, 11 patients started on insulin aspart ± OGLD of which 2 (18.2%) were insulin naïve and 9 (81.8%) were insulin users [Table 14].

Mean HbA^ and mean PPPG improved from baseline to study end in those who started on or were switched insulin aspart ± OGLDs [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. Major hypoglycaemia was observed in the insulin user group after 24 weeks. SADRs were reported in 0.5% of insulin user group. A small weight gain was observed for the overall cohort. 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 Rabat-Sale-Zemmour-Zaer region, Morocco.

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

Parameter N Baseline Week Change from

24 baseline

Hypoglycaemia,

events/patient-year

Insulin users 9 0.0 0.0 0.0

Body weight, kg

Insulin users 6 72.0 72.8 0.8

Quality of life,

VAS scale (0-100)

Insulin users 7 61.4 65.7 4.3

VAS: Visual analogue scale

Table 15: Insulin dose

Insulin N Pre-study N Baseline N Week 24

dose, U/day

Insulin users 9 34.8 9 15.7 8 42.8

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 (%) 7 9.0 7.8 -1.2

FPG, mean (mmol/L) 4 10.1 10.1 0.0

PPPG, mean (mmol/L) 2 14.1 7.9 -6.2

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

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

References

1. IDF Diabetes Atlas. 5th ed. 2011. Available from: http://www.idf.org/ atlasmap/atlasma [Last accessed on 2013 June 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: Chraibi A, Belmejdoub G. Clinical experience with insulin detemir type 2 diabetes mellitus, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Rabat-Sale-Zemmour-Zaer Region cohort of the Achieve study. Indian J Endocr Metab 2013;17:S413-7. Source of Support: Nil, Conflict of Interest: None declared.

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