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CHAPTER 1 EXECUTIVE SUMMARY 3
Key Findings 3
CHAPTER 2 INTRODUCTION AND SCOPE 6
Scope of the analysis 6
Related reports 7
Common abbreviations used throughout this report: 7
CHAPTER 3 COUNTRY TREATMENT ALGORITHMS 9
Introduction 9
US 10
Japan 12
France 14
Germany 16
Italy 18
Spain 20
UK 22
5 European Markets Summary Algorithms 24
CHAPTER 4 DISEASE DEFINITION AND OVERVIEW 26
Definition of diabetes 26
Segmentation of diabetes 26
Type 1 diabetes 26
Type 1.5 diabetes 27
Type 2 diabetes 27
Etiology and Risk factors 28
Mechanisms of development of diabetes 28
Genetic or acquired causes 28
Risk factors 28
Obesity 29
T2 diabetes epidemic hand-in-hand with obesity epidemic 29
Race 30
T2 diabetes more prevalent in Hispanics and African Americans than in Caucasians 30
Family history 31
T2 diabetes in first-degree relatives is a strong prognostic indicator 31
Advanced age 31
Gender and other factors 31
Gestational diabetes mellitus 32
CHAPTER 5 EPIDEMIOLOGY OF DIABETES 33
Epidemiology of diabetes 33
Diabetes presents a worldwide public health problem 33
Current prevalence of type 1 and type 2 diabetes 34
Increasing prevalence of type 2 diabetes 34
Increase in prevalence to epidemic proportion 35
Datamonitor epidemiology forecast 36
Methodology 39
Epidemic rise in incidence of T2 diabetes 40
CHAPTER 6 DIAGNOSIS AND PATIENT MANAGEMENT 43
Patient management 43
The majority of diabetics are diagnosed and managed by primary care practitioners 43
Referral to a specialist 44
Diagnosis rates in type 2 diabetes 45
Reasons for the poor diagnosis rate 46
Insidious nature of the disease 46
Lack of screening 47
Awareness of guidelines 47
Validity of diagnostic tests 48
Misdiagnosis of T2 and T1 diabetes 50
Strategies to increase diagnosis rates 50
The need for a targeted screening program 51
Late stage of diagnosis 52
Disease indicators at presentation 53
CHAPTER 7 DIABETIC COMPLICATIONS 57
Complications of type 2 diabetes 57
Microvascular complications 58
Nephropathy 58
Retinopathy 61
Neuropathy 62
Macrovascular complications 65
Effect of macrovascular complications on type 2 diabetes treatment 66
End-stage disease considerations 67
Co-morbidities 68
Obesity 68
Effect of obesity on type 2 diabetes treatment 70
Hypertension 70
Dyslipidemia 71
CHAPTER 8 TREATMENT OPTIONS FOR TYPE 2 DIABETES 73
Treatment guidelines for type 2 diabetes 73
Clinical practice guidelines from the ADA/EASD 73
The AACE clinical practice guidelines 76
Lifestyle management for type 2 diabetes 77
Pharmacological treatment for type 2 diabetes 79
Oral antidiabetic (OAD) agents 81
Biguanides (metformin) 81
Sulfonylureas 81
Prandial glucose regulators (PGRs) 82
Thiazolidinediones 84
Alpha-glucosidase inhibitors (AGIs) 85
Incretin Mimetics 86
Glucagon-like peptide-1 agonists (GLP-1s) 86
Dipeptidyl peptidase-4 inhibitors (DPP-4s) 88
Insulins 88
Lantus 88
Levemir 89
Humalog 89
Novolog 90
NovoLin 91
Humulin 91
Apidra 92
CHAPTER 9 FIRST-LINE PHARMACOTHERAPY 93
Overview 93
First-line monotherapy 93
First-line combination therapy 96
CHAPTER 10 SECOND-LINE PHARMACOTHERAPY 98
Overview 98
Second-line monotherapy 99
Second-line combination therapy 100
CHAPTER 11 THIRD-LINE PHARMACOTHERAPY 103
Overview 103
Third-line monotherapy 104
Third-line combination therapy 105
CHAPTER 12 TRANSITION TO INSULIN THERAPY 108
History of insulin therapy 108
Indications for insulin use in type 2 diabetes 110
Time of initiation of insulin therapy 113
Drivers for insulin uptake 114
Improved of glycemic control 114
Earlier initiation of insulin therapy 115
Restraints for uptake of insulin 116
Weight gain 117
Risk of hypoglycemia 118
Patient education and compliance with subcutaneous injections 119
Cost and reimbursement issues 119
Use of insulin 120
Overall usage of insulin 120
Changes to insulin prescribing habits 122
Past, present and future use 122
Usage of different types of insulin 123
Physician perception of different types of insulin 124
Brand map overview 124
Interpreting a brand map 124
Long-acting insulins: Lantus (Glargine) and Levemir (Detemir) 125
Short-acting insulins: Humalog (Lispro) and Apidra (Glulisine) 126
Failure of inhaled insulin 126
CHAPTER 13 PRESCRIBING TRENDS IN THE TREATMENT OF TYPE 2 DIABETES 129
The evolution of the treatment regimen 129
Factors determining the alteration to a treatment regimen 130
Patient empowerment 131
Uptake of single-pill combination (SPC) therapies 132
The evolution of the treatment algorithm 134
Sulfonylureas and Metformin 135
Loss of confidence in TZDS 137
PGRs and AGIs 137
Insulin shifted down treatment algorithm by new classes of incretin mimetic 137
CHAPTER 14 PRESCRIBING INFLUENCES IN THE TREATMENT OF TYPE 2 DIABETES 139
Factors influencing prescribing decisions in T2 diabetes 139
Efficacy is the major prescribing influence in type 2 diabetes 140
Safety is also an important prescribing influence 140
Cost issues possibly not as important as for other indications 141
Beta cell salvage and time to secondary failure 142
Mode of administration 143
Dosing frequency 143
Physician perception of existing therapies in type 2 diabetes 143
Brand map overview 144
Interpreting a brand map 144
Physician perception of established classes of antidiabetic drugs 145
Physician perception of novel classes of antidiabetic drugs 147
CHAPTER 15 UNMET NEEDS IN TYPE 2 DIABETES 150
Overview 150
Each unmet need is ordered by relative importance, and discussed in more detail below: 151
Insulin response variability 151
Poor diagnosis 153
Routine screening programs to improve poor diagnosis rate 153
Guideline awareness 155
Non-invasive blood glucose measurement (BMG) 158
Tolerability 159
Incidence of hypoglycemic events 159
Delivery-related complications 160
Weight gain 161
Mode of administration (MoA) 161
Reluctance to self-inject 162
Patient compliance 162
Insulin secretion patterns 162
Patient awareness 163
Efficacy 164
APPENDIX A 166
Bibliography 166
APPENDIX B 173
Physician research methodology 173
Physician sample breakdown 173
US 173
Japan 174
France 174
Germany 175
Italy 175
Spain 176
UK 176
APPENDIX C 177
The survey questionnaire 177
List of Tables
Table 1: Prevalence of diabetes mellitus is forecast to increase by the International Diabetes Foundation (IDF), 2003-2025 34
Table 2: Prevalence rate of type 1 and type 2 diabetes in the seven major markets (%), 2006-2015 38
Table 3: Estimated absolute prevalence of diabetes in the seven major markets (millions), 2007-2017 41
Table 4: Framingham Heart Study data on lipid levels in men and women with and without diabetes 72
Table 5: ADA evidence grading system for clinical practice guidelines 74
Table 6: Comparator Insulins by onset of action, 2006 109
Table 7: US physician sample breakdown, 2007 173
Table 8: Japan physician sample breakdown, 2007 174
Table 9: France physician sample breakdown, 2007 174
Table 10: Germany physician sample breakdown, 2007 175
Table 11: Italy physician sample breakdown, 2007 175
Table 12: Spain physician sample breakdown, 2007 176
Table 13: UK physician sample breakdown, 2007 176
List of Figures
Figure 1: Population demographic for diagnosed type 2 diabetic patients in the US, 2007 10
Figure 2: Population, treatment and treatment outcome data for type 2 diabetic patients in US, 2007 11
Figure 3: Population demographic for diagnosed type 2 diabetic patients in Japan, 2007 12
Figure 4: Population, treatment and treatment outcome data for type 2 diabetic patients in Japan, 2007 13
Figure 5: Population demographic for diagnosed type 2 diabetic patients in France, 2007 14
Figure 6: Population, treatment and treatment outcome data for type 2 diabetic patients in France, 2007 15
Figure 7: Population demographic for diagnosed type 2 diabetic patients in Germany, 2007 16
Figure 8: Population, treatment and treatment outcome data for type 2 diabetic patients in Germany, 2007 17
Figure 9: Population demographic for diagnosed type 2 diabetic patients in Italy, 2007 18
Figure 10: Population, treatment and treatment outcome data for type 2 diabetic patients in Germany, 2007 19
Figure 11: Population demographic for diagnosed type 2 diabetic patients in Spain, 2007 20
Figure 12: Population, treatment and treatment outcome data for type 2 diabetic patients in Italy, 2007 21
Figure 13: Population demographic for diagnosed type 2 diabetic patients in the UK, 2007 22
Figure 14: Population, treatment and treatment outcome data for type 2 diabetic patients in the UK, 2007 23
Figure 15: Population, treatment and treatment outcome data for RCC in the 5EU, 2007 (continued) 24
Figure 16: Population, treatment and treatment outcome data for type 2 diabetic patients in the 5EU, 2007 25
Figure 17: Specialty of physician diagnosing and managing diabetic patients. 43
Figure 18: Estimated percentage of diagnosed type 2 diabetics in the seven major markets 46
Figure 19: Estimated percentage of diagnosed type 2 diabetics who are classified as either overweight or obese. 53
Figure 20: Estimated percentage of diagnosed type 2 diabetics who are classified as prehypertensive or hypertensive. 54
Figure 21: Estimated percentage of diagnosed type 2 diabetics with each degree of plasma cholesterol elevation 55
Figure 22: Proportion of type 2 diabetics in the seven major markets with complications 57
Figure 23: Proportion of type 2 diabetics with complications that suffer from microvascular and/or macrovascular complications in the seven major markets 58
Figure 24: Proportion of type 2 diabetics with different stages of nephropathy in the seven major markets 59
Figure 25: Average time from the diagnosis of diabetes required for the development of different stages of diabetic nephropathy in the seven major markets, 2007. 60
Figure 26: Proportion of type 2 diabetics with retinopathy in the seven major markets 61
Figure 27: Average time required for the development of diabetic retinopathy in the seven major markets 62
Figure 28: Proportion of type 2 diabetics with neuropathy in the seven major markets 64
Figure 29: Average time required for the development of diabetic neuropathy in the seven major markets 64
Figure 30: Proportion of type 2 diabetics with macrovascular complications in the seven major markets 65
Figure 31: Average time for the development of macrovascular complications in the seven major markets 66
Figure 32: Proportion of type 2 diabetics with serious complications (e.g. ESRD, acute MI, amputation) 68
Figure 33: Treatment algorithm for type 2 diabetes, recommended by the 2006 ADA/EASD clinical practice guidelines. 75
Figure 34: Percentage of diagnosed type 2 patients receiving drug therapy and/or lifestyle management in the seven major markets 77
Figure 35: Breakdown of patients by line of treatment in the seven major markets 80
Figure 36: Mechanism of action of sulfonylureas and prandial glucose regulators 82
Figure 37: Percentage of patients on monotherapy versus. combination therapy at first-line therapy, 2007. 94
Figure 38: Breakdown of overall drug class usage in patients on first-line therapy in the seven major markets 96
Figure 39: Breakdown of combination therapy at first-line in the seven major markets 97
Figure 40: Percentage of patients in monotherapy vs. combination therapy in second-line therapy 99
Figure 41: Breakdown of drug class use in patients on second-line monotherapy in the seven major markets 100
Figure 42: Breakdown of drug class use in patients on second-line monotherapy in the seven major markets 101
Figure 43: Percentage of patients on monotherapy versus combination therapy in third-line therapy, 2007. 104
Figure 44: Breakdown of drug class use in patients on third-line monotherapy in the seven major markets, 2007. 105
Figure 45: Breakdown of drug regimen use in patients on third-line combination therapy in the seven major markets 107
Figure 46: Common insulin regimens 110
Figure 47: When to start insulin therapy in type 2 diabetes? 112
Figure 48: Time to the inititation of insulin therapy 114
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