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Stakeholder Insight: Insulin Use in Type 2 Diabetes - From Last Resort to Early Intervention


Description:
Only 13-28% of drug-treated type 2 diabetes patients receive insulin therapy. The late initiation of insulin reflects the general trend that it is a last resort therapy in the treatment of type 2 diabetes. We believe that there will be a shift towards earlier initiation of insulin in the future, along with increased uptake, following the introduction of non-injected insulin.

Scope
Analysis of interviews with 388 physicians in the 7 major markets, validated via in-depth interviews with international experts
Determination of the prevalence of type 1 and type 2 diabetes, with forecasts to 2012
Analysis of the use of insulin therapy in the treatment of type 2 diabetes by line of therapy and evaluation of early vs. late initiation of insulin
Assessment of the potential patient population for non-injected insulin: evaluation of switch from injected insulin and add-on to OAD therapy
Highlights
Due to rising rates of obesity and the aging population, type 2 diabetes is an emerging epidemic: We estimate there will be 50.1m diabetics in the seven major markets in 2012. Despite the large patient population, Our physician research reveals that only 50% of type 2 diabetics across the seven major markets are diagnosed.

The late initiation of insulin reflects the trend that insulin is a therapy of last resort in the treatment of type 2 diabetes. Although some experts believe that the earlier initiation of insulin is emerging, additional clinical trials are required to support this strategy.

Non-injected insulins are expected to overcome the key unmet need in the insulin market by providing a more convenient mode of administration, and they are also expected to increase the overall use of insulin in type 2 diabetes patients and shorten the time to initiation.

Reasons to Purchase
Understand the factors limiting the use of insulin in type 2 diabetes, based on both physician and patient perception
Validate product forecasting based on diagnosis and treatment rates, and the estimated future use of insulin in the treatment of type 2 diabetes
Recognize lucrative target populations, in terms of unmet need and patient potential, in order to successfully position developmental products


Contents: TABLE OF CONTENTS
CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the analysis 4
Datamonitor insight into the type 2 diabetes insulin market 5
Summary 12
Key metrics 13
CHAPTER 2 INTRODUCTION AND SCOPE 23
Coverage of the Stakeholder Insight Survey 23
CHAPTER 3 COUNTRY TREATMENT TREES 26
Introduction to the treatment trees 26
US 27
Japan 29
France 31
Germany 33
Italy 35
Spain 37
UK 39
CHAPTER 4 DISEASE DEFINITION AND EPIDEMIOLOGY 41
Definition of type 2 diabetes 41
Etiology of type 2 diabetes 41
Complications of type 2 diabetes 42
Nephropathy 42
Retinopathy 43
Neuropathy 43
Macrovascular complications 44
Epidemiology of type 1 and type 2 diabetes 44
Current prevalence of type 1 and type 2 diabetes 44
Methodology 45
Future prevalence of type 2 diabetes 46
Methodology 47
CHAPTER 5 DIAGNOSIS AND TREATMENT RATES 49
Diagnosis 49
Symptoms and diagnosis 49
Diagnosis rates 51
Who manages patients with type 2 diabetes? 53
Treatment options 55
Existing therapy for type 2 diabetes 55
History of insulin 56
Treatment rates 57
Treatment guidelines for type 2 diabetes 60
Clinical practice guidelines from the ADA 60
The AACE system of Intensive Diabetes Self-Management 62
Physician and patient understanding of treatment guidelines 62
CHAPTER 6 INSULIN PRESCRIBING TRENDS 64
Indications for insulin use in type 2 diabetes 64
Overall use of insulin in type 2 diabetes 66
Current prescribing of insulin in type 2 diabetes 67
Change in insulin prescribing over the last three years 70
Guidelines advocating more aggressive treatment of type 2 diabetes 71
Analysis of past changes by physician type 73
Change in the prescribing of insulin over the next three years 74
Analysis of future changes by physician type 76
Reasons for and against insulin use in type 2 diabetes 80
Factors driving the use of insulin in type 2 diabetes 80
Improvement of glycemic control 80
Factors limiting the use of insulin in type 2 diabetes 82
Risk of hypoglycemia 83
Patient compliance with subcutaneous injections 88
Cost and reimbursement issues 92
Possible weight gain 96
Other barriers: attitude of the healthcare professional towards the use of insulin in type 2 diabetes 101
Other barriers: self-monitoring of blood glucose (SMBG) 103
Other barriers: incidence of heart failure increased in insulin-treated patients 109
CHAPTER 7 BREAKDOWN OF INSULIN THERAPY 111
Overview of line of therapy in type 2 diabetes 112
Breakdown by line of therapy 112
Monotherapy versus combination therapy 113
Breakdown of insulin use by line of therapy 115
Overview of insulin use by line of therapy 115
Approved insulin combinations 116
Breakdown of insulin prescribing at first line by physician type 117
Breakdown of insulin prescribing at second line by physician type 119
Second-line monotherapy 119
Second-line combination therapy 121
Breakdown of insulin prescribing at third line and beyond by physician type 125
Third-line monotherapy 125
Third-line combination therapy 126
Analysis of early versus late initiation of insulin 128
When is insulin therapy currently initiated in type 2 diabetics? 128
Number of years from diagnosis to initiation of insulin 128
Number of OADs prescribed before insulin is initiated 129
Clinical evidence supporting early initiation of insulin 129
Breakdown of insulin use by type and brand 131
Breakdown of insulin use by insulin type 134
Past and future changes in the use of different insulin types 137
Breakdown of insulin use by brand 148
Aventis’s Lantus – benefiting from its more predictable glycemic control 149
Eli Lilly’s Humalog – experiencing increasing uptake 152
Novo Nordisk’s NovoLog/NovoRapid – retaining strong growth 153
CHAPTER 8 POTENTIAL FOR NON-INJECTED INSULINS 155
Overview of the non-injected insulin pipeline 155
Inhaled insulin 156
Exubera – the most advanced non-injected insulin 158
Improving glycemic control in patients failing on combination OAD therapy 159
Exubera versus rosiglitazone in patients uncontrolled on diet and exercise 159
Success of Exubera will predict future of inhaled insulin 159
AERx iDMS – improving patient compliance 160
Inhaled insulin via AERx iDMS versus subcutaneous insulin injection 160
Technosphere Insulin – marketing partner required 162
AIR insulin – lack of financial support from Eli Lilly 163
Phase I inhaled insulin projects 164
Oral insulin 165
Oralin – termination of agreement with Eli Lilly 166
Emisphere oral insulin – seeking a partner to further development 167
HIM2 – further investigation in type 2 diabetes patients required 168
Macrulin – continued development uncertain 169
Barriers for non-injected insulin 169
Comparable efficacy and safety 170
Improved patient compliance 171
Reproducibility and accuracy of dosing 172
Switching patients from injected to non-injected insulin 173
Competitive pricing 174
Patient potential for non-injected insulin 175
Switch from injected insulin or OAD therapy 176
Add-on to existing OAD therapy 177
Will non-injected insulin result in the earlier initiation of insulin? 179
CHAPTER 9 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS 181
Prof Burden 182
Treatment guidelines 182
Initiation of insulin in type 2 diabetes 184
Self-monitoring blood glucose (SMBG) 188
Choice of insulin therapy 190
The advent of non-injected insulins 191
Prof Fonseca 193
Treatment guidelines 193
Initiation of insulin in type 2 diabetes 193
Self-monitoring blood glucose (SMBG) 195
Choice of insulin therapy 196
The advent of non-injected insulins 198
David McAughey 199
Treatment guidelines and patient awareness 199
Initiation of insulin in type 2 diabetes 203
Self-monitoring blood glucose (SMBG) 207
The advent of non-injected insulins 209
Emma Bunn 211
Treatment guidelines and patient awareness 211
Initiation of insulin in type 2 diabetes 214
Self-monitoring blood glucose (SMBG) 217
The advent of non-injected insulins 219
APPENDIX A BIBLIOGRAPHY 221
Epidemiology 221
General bibliography 222
APPENDIX B 226
Physician research methodology 226
Physician sample breakdown 226
US 226
Japan 227
France 227
Germany 228
Italy 228
Spain 229
UK 229
Type 2 diabetes Insight survey questionnaire 231
Section 1: Physician perceptions of patient segmentation 231
Section 2: Treatment patterns in first-, second- and third-line therapy 232
Section 3: Key branded products 234
Section 5: Prescribing trends 234
Section 7: Insulin therapy in type 2 patients 235
Disclaimer 238





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