0Original Article
Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Kolkata cohort of the A1chieve study
Anirban Majumder, Awadhesh Kumar Singh1'2, Kalyan Kumar Gangopadhyay3, Ranjini Sen4, Raman Shetty4, Sujoy Majumdar1
KPC Medical College and Hospital, 'GD hospital & Diabetes Institute, Kolkata, 2Sun Valley Diabetes & Endocrine Centre, Guwahati, 3Fortis Hospital, 4Novo Nordisk India Pvt. Ltd., Bangalore, 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 Kolkata, India. Results: A total of 576 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 = 417), insulin detemir (n = 70), insulin aspart (n = 55), basal insulin plus insulin aspart (n = 19) and other insulin combinations (n = 15). At baseline, glycaemic control was poor for both insulin naïve (mean HbA1c: 8.3%) and insulin user (mean HbA1c: 8.6%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: -1.3%, 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, Kolkata, 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 Kolkata, India.
Materials and Methods
Please refer to editorial titled: The Achieve study: Mapping the Ibn Battuta trail.
Results
A total of 576 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
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Corresponding Author: Dr. Raman Shetty, Novo Nordisk India Pvt. Ltd., Plot No. 32, 47 - 50, EPIP Area, Whitefield, Bangalore, India. E-mail: rasy@novonordisk.com
Majumder, et al.: A1chieve study experience from Kolkata, India
population. The majority of patients (72.4%) started on or switched to biphasic insulin aspart. Other groups were insulin detemir (n = 70), insulin aspart (n = 55), basal insulin plus insulin aspart (n = 19) and other insulin combinations (n = 15).
Number of patients 464 112 576
Male N (%) 301 (65.0) 75 (67.0) 376 (65.4)
Female N (%) 162 (35.0) 37 (33.0) 199 (34.6)
Age (years) 49.7 59.0 52.6
Weight (kg) 67.1 67.2 71.2
BMI (kg/m2) 25.4 25.7 26.8
Duration of DM (years) 6.6 13.3 6.7
No therapy 13
>2 OGLD 131 32 163
HbA|c 8.3 8.6 8.4
FPG (mmol/L) 10.3 9.9 10.2
PPPG (mmol/L) - - -
Macrovascular 169 (36.4) 88 (78.6) 257 (44.6)
complications, N (%)
Microvascular 148 (31.9) 69 (61.6) 217 (37.7)
complications, N (%)
Pre-study therapy, N (%)
Insulin users 112 (19.4)
OGLD only 451 (78.3)
No therapy 13 (2.3)
Baseline therapy, N (%)
Insulin detemir±OGLD 70 (12.2)
Insulin aspart±OGLD 55 (9.5)
Basal+insulin aspart±OGLD 19 (3.3)
Biphasic insulin aspart±OGLD 417 (72.4)
Others 15 (2.6)
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 increased in both insulin naïve (from 0.0 events/patient-year to 0.7 events/patient-year) and insulin user (from 0.0 events/patient-year to 1.2 events/patient-year) groups. SADRs including major hypoglycaemic events did not occur in any of the study patients. Blood pressure decreased from baseline, while overall lipid profile improved at week 24 in the total cohort [Tables 2 and 3].
Mean HbA1c and FPG values improved from baseline to study end in the total cohort [Table 4].
Biphasic insulin aspart ± OGLD
Of the total cohort, 417 patients started on biphasic insulin aspart ± OGLD, of which 332 (79.6%) were insulin naïve and 85 (20.4%) were insulin users. After 24 weeks of starting or switching to biphasic insulin aspart, hypoglycaemic events increased in both insulin naïve (from 0.0 events/patient-year to 0.8 events/patient-year) and insulin user (from 0.0 events/patient-year to 1.4 events/patient-year) groups [Tables 5 and 6].
Mean HbA1c and FPG values 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, 19 patients started on basal + insulin aspart ± OGLD, of which 11 (57.9%) were insulin
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/patient-year
All 464 0.0 0.7 0.7
Nocturnal 0.0 0.1 0.1
Major 0.0 0.0 0.0
Hypoglycaemia (insulin users), events/patient-year
All 112 0.0 1.2 1.2
Nocturnal 0.0 0.0 0.0
Major 0.0 0.0 0.0
Body weight, kg
Insulin naïve 408 67.1 67.2 0.1
Insulin users 97 67.5 67.6 0.1
Lipids and BP (insulin users)
LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 112 3.7 (3, 2.7) 3.6 (13, 12.4) -0.1
HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 126 1.0 (83, 65.9) 1.1 (78, 74.3) 0.1
TG, mean (mmol/L), (N, % <2.3 mmol/L) 64 1.8 (6, 9.4) 1.7 (58, 93.5) -0.1
SBP, mean (mmHg), (N, % <130 mmHg) 460 126.8 (242, 52.6) 121.9 (285, 69.0) -4.9
Lipids and BP (insulin users)
LDL-C, mean (mmol/L), (N, % <2.5 mmol/L) 32 3.7 (5, 15.6) 3.2 (15, 44.1) -0.5
HDL-C, mean (mmol/L), (N, % >1.0 mmol/L) 32 1.0 (20, 62.5) 1.1 (25, 75.8) 0.1
TG, mean (mmol/L), (N, % <2.3 mmol/L) 18 2.1 (14, 77.8) 1.5 (18, 94.7) -0.6
SBP, mean (mmHg), (N, % <130 mmHg) 111 140.7 (17, 15.3) 131.9 (35, 35.7) -8.8
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
Majumder, et al.: A1chieve study experience from Kolkata, India
naïve and 8 (42.1%) were insulin users. After 24 weeks of starting or switching to basal + insulin aspart, hypoglycaemia was nil, similar to baseline in both the groups [Tables 8 and 9].
Mean HbA1c and FPG values 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, 70 patients started on insulin
detemir ± OGLD was 70, of which 60 (85.7%) were insulin naïve and 10 (14.3%) were insulin users. After 24 weeks of starting or switching to insulin detemir, hypoglycaemic events increased from 0.0 events/patient-year to 0.5 events/ patient-year in insulin naïve group while hypoglycaemia was nil in insulin users group, similar to baseline [Tables 11 and 12].
Mean HbA^ and FPG values improved from baseline to study end in those who started on or were switched to insulin detemir ± OGLDs for both insulin-naïve and insulin user groups [Table 13].
Table 3: Insulin dose
Insulin N Pre-study N Baseline N Week 24
dose, U/day
Insulin naïve 0 0 464 23.7 4I7 28.7
Insulin users 112 30.2 II2 33.8 98 37. I
Table 4: Overall efficacy data
Parameter N Baseline Week Change from
24 baseline
Glycaemic control
(insulin naïve)
HbA|c, mean (%) 387 8.3 7.I -I.3
FPG, mean (mmol/L) 4I4 I0.3 7.I -3.I
Glycaemic control
(insulin users)
HbA|c, mean (%) 93 8.6 7.2 -I.4
FPG, mean (mmol/L) 97 9.9 6.8 -3.I
PPPG, mean (mmol/L) - - - -
Table 7: Biphasic insulin aspart±oral glucose-lowering drug efficacy data
Achievement of HbA|c <7.0% at week 24 Insulin naïve (% of patients) Insulin users (% of patients)
36.4 27.6
HbA,c: Glycated haemoglobin A,c, FPG: Fasting plasma glucose, PPPG: Postprandial plasma glucose
Parameter N Baseline Week Change from
24 baseline
Glycaemic control
(insulin naïve)
HbA|c, mean (%) 286 8.4 7.I -I.3
FPG, mean (mmol/L) 30I I0.3 7.2 -3.I
Glycaemic control
(insulin users)
HbA|c, mean (%) 7I 8.6 7.2 -I.4
FPG, mean (mmol/L) 75 9.7 6.8 -2.9
HbA,c: Glycated haemoglobin A,c, FPG: Fasting 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 II 0.0 0.0 0.0
Insulin users 8 0.0 0.0 0.0
Body weight, kg
Insulin naïve 9 68.3 68.4 0.I
Insulin users 7 73.I 72.2 -I.0
Table 5: Biphasic insulin aspart±oral glucose-lowering drug safety data
Table 9: Insulin dose
Parameter N Baseline Week Change from
24 baseline
Hypoglycaemia,
events/patient-year
Insulin naïve 332 0.0 0.8 0.8
Insulin users 85 0.0 I.4 I.4
Body weight, kg
Insulin naïve 30I 67.9 67.9 0.0
Insulin users 75 66.5 66.6 0.I
VAS: Visual analogue scale
Table 6: Insulin dose
Insulin N Pre-study N Baseline N Week 24
dose, U/day
Insulin naïve 0 0 332 25.0 303 29.2
Insulin users 85 32.I 85 33.8 75 36.9
Insulin dose, U/day
N Pre-study N Baseline N Week 24
Insulin naïve Insulin users
0 26.4
39.9 45.5
53.8 52.0
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 (%) FPG, mean (mmol/L) Glycaemic control (insulin users) HbA|c, mean (%) FPG, mean (mmol/L)
8.I I0.7
7.0 7.3
7.2 6.5
-I.2 -3.5
-I.7 -3.3
HbA,c: Glycated haemoglobin A,c, FPG: Fasting plasma glucose
Majumder, et al.: A1chieve study experience from Kolkata, India
Table 11: Insulin detemir±oral glucose-lowering drug Table 14: Insulin aspart±oral glucose-lowering drug
safety data safety data
Parameter N Baseline Week Change from
24 baseline
Hypoglycaemia, events/patient-year
Insulin naïve 6О О.О О.5 О.5
Insulin users I0 О.О О.О О.О
Body weight, kg
Insulin naïve 48 66.9 67.2 О.3
Insulin users 8 7О.О 7О.4 О.4
VAS: Visual analogue scale
Insulin naïve 0 0 60 13.0 53 17.7
Insulin users 10 21.0 10 20.0 8 25.0
Parameter N Baseline Week Change from
24 baseline
Glycaemic control
(insulin naïve)
HbA1c, mean (%) 46 8.2 7.0 -I.2
FPG, mean (mmol/L) 53 I0.3 7.0 -3.2
Glycaemic control
(insulin users)
HbA1c, mean (%) 8 8.6 7.I -I.5
FPG, mean (mmol/L) 7 I2.0 6.7 -5.3
HbAIc: Glycated haemoglobin AIc, FPG: Fasting plasma glucose
Insulin aspart ± OGLD
Of the total cohort, 55 patients started on insulin aspart ± OGLD was 55, of which 54 (98.1%) were insulin naïve and 1 (1.9%) was insulin user. After 24 weeks of starting or switching to insulin aspart, hypoglycaemic events increased from 0.0 events/patient-year to 0.3 events/patient-year in insulin naïve group whereas hypoglycaemia was nil in insulin user, similar to baseline [Tables 14 and 15].
Mean HbA^ and FPG values improved from baseline to study end in those who started on or were switched to insulin aspart ± OGLDs for insulin-naïve group [Table 16].
Conclusion
Our study reports improved glycaemic control (HbA1c, FPG) following 24 weeks of treatment with any of the insulin analogues (Biphasic insulin aspart; Basal + insulin aspart; Insulin detemir; Insulin aspart) with or without
Parameter N Baseline Week Change from
24 baseline
Hypoglycaemia, events/patient-year
Insulin naïve 54 0.0 0.3 0.3
Body weight, kg
Insulin naïve 45 63.2 63.2 0.0
Table 15: Insulin dose
Insulin N Pre-study N Baseline N Week 24
dose, U/day
Insulin naïve 0 0 54 22.5 47 31.5
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 (%) 44 8.2 7.1 -1.1
FPG, mean (mmol/L) 46 9.8 6.9 -2.8
HbA|c: Glycated haemoglobin A|c, FPG: Fasting plasma glucose
OGLD. A small increase in body weight was observed for the total cohort. SADRs 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 Kolkata, 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: Majumder A, Singh AK, Gangopadhyay KK, Sen R, Shetty R, Majumdar S. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Kolkata cohort of the Achieve study. Indian J Endocr Metab 2013;17:S584-7.
Source of Support: Nil, Conflict of Interest: None declared.
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
