Market Report Source

Overview

Diabetes affects more than an estimated 18 million people in the United States and approximately 194 million adults worldwide. The World Health Organization projects that the number of people with diabetes will double to 366 million by 2030.

Thiazolidediones (PPAR gamma agonists), such as Actos and Avandia, are currently the market leading therapeutic agents used to treat patients with type-2 diabetes, with 2007 worldwide sales of $3.5 billion and $1.7 billion respectively. However, drugs with novel mechanism that are currently in development such as DPP-IV (dipeptidyl peptidase-4) inhibitors and GLP-1 (Glucagon-like peptide-1) antagonists could pose a competitive threat to the market leaders in the near future. In this report, Austin Research Group profiles the 35 most promising compounds in mid-to-late stage development for the treatment of Type-2 Diabetes. The assessment provides decision makers with insight into the crowded R&D environment for Type-2 Diabetes therapeutics and analyzes clinical intelligence on key competitors that have the potential to impact the market over the next five to seven years.

Austin Research Group’s Therapeutic Clinical Intelligence Report Series provides clients within the pharmaceutical and biotechnology industry with detailed information and analysis of competitive products in the development pipeline. Reports contain synthesized information and analysis of clinical development activities for products within multiple therapeutic categories and contain detailed evaluations of completed and ongoing competitor studies that capture key elements of the study protocol including:

• Trial design
• Start and end dates
• Study size and patient type
• Number of participating sites
• Dosing regimen
• Endpoints
• Safety and efficacy results

Clients utilize the report as a resource to support key decisions including:

• Analyzing the overall depth and breadth of the competitive landscape within a therapeutic area
• Assessing target product profiles of key current and future competitors
• Benchmarking competitor clinical trial designs and results
• Developing clinical analogues to support go-no-go decisions
• Identifying clinical hurdles posed by competitors
• Designing clinical trials more effectively to maximize a product’s penetration

Table of Contents

Section 1: Executive Summary 12
Scope of Research & Analysis 13
Type-2 Diabetes Disease Overview 14
Overview of Progression to Type 2 Diabetes 15
Global Projections for the Diabetes Epidemic: 2003-2025 16
Epidemiology of T2 Diabetes: Current and predicted prevalence 17
Currently Available Treatments for T2 Diabetes 18
Unmet Need in Type-2 Diabetes Market 19
FDA Summary Guidance for Development of T2 Diabetes Therapeutics 20
Overview of Competitive Landscape: Late-Stage Products Profiled in Intelligence Report 21
Overview of Competitive Landscape: Mid & Early Stage Products Profiled in Intelligence Report 22
Competitive Launch Timeline Analysis 23
Overview of Clinical Trials Landscape 24

Section 2: The Current Market Leaders in T2 Diabetes 25
Actos Product Overview—Competitor Snapshot 26
Avandia Product Overview—Competitor Snapshot 27
Byetta Product Overview—Competitor Snapshot 28
Januvia Product Overview—Competitor Snapshot 29
Symlin Product Overview—Competitor Snapshot 30
Galvus Product Overview—Competitor Snapshot 31

Section 3: Future Competitive Threats Novel Therapeutics in Late-Stage Development 32
Alogliptin (SYR-322) 33
Alogliptin Product Overview—Competitor Snapshot 34
Alogliptin Phase II Study Design & Results 35
Alogliptin Phase III Study Design (Ongoing) 36
Alogliptin Phase III Study Design (Ongoing) 37
Alogliptin Phase III Study Design (Ongoing) 38
Alogliptin Phase III Study Design (Ongoing) 39
Alogliptin Phase III Study Design & Results 40
Alogliptin Phase III Study Design (Ongoing) 41
Alogliptin Phase III Study Design (Ongoing) 42
Liraglutide 43
Liraglutide Product Overview—Competitor Snapshot 44
Liraglutide Phase II Study Design & Results 45
Liraglutide Phase II Study Design & Results 46
Overview of Liraglutide Registrational Program 47
Liraglutide Phase III Study Design & Results LEAD 1 48
Liraglutide Phase III Study Design (Ongoing) LEAD 2 49
Liraglutide Phase III Study Design & Results LEAD 3 50
Liraglutide Phase III Study Design (Ongoing) LEAD 4 51
Liraglutide Phase III Study Design (Ongoing) LEAD 5 52
Liraglutide Phase III Study Design & Results LEAD 6 53
Liraglutide Phase III Study Design (Ongoing) Japan NDA-Enabling Trial 54
Saxagliptin 55
Saxagliptin Product Overview—Competitor Snapshot 56
Saxagliptin Phase I Studies (#1 & #2): Design & Results 57
Saxagliptin Phase III Study Design & Results 58
Saxagliptin Phase III Study Design 59
Saxagliptin Phase III Study Design 60
Saxagliptin Phase III Study Design & Results 61
Saxagliptin Phase III Study Design (Ongoing) 62
Saxagliptin Phase III Study Design (Ongoing) 63
AGI-1067 64
AGI-1067 Product Overview—Competitor Snapshot 65
AGI-1067 Phase III Study Design & Interim Results (Ongoing) ANDES (AGI-1067 as a Novel Antidiabetic Agent Evaluation Study) 66
Exanatide LAR (exenatide) 67
Exenatide LAR Product Overview—Competitor Snapshot 68
Exenatide LAR Phase II Study Design & Results 69
Exenatide LAR Phase II Study Design (Ongoing) 70
Exenatide LAR Phase III Study Design & Results-DURATION-1 71
Exenatide LAR Phase III Study Design (Ongoing) 72
Exenatide LAR Phase III Study Design (Ongoing) 73
Exenatide LAR Phase III Study Designs (Ongoing) 74
Dapagliflozin 75
Dapagliflozin Product Overview—Competitor Snapshot 76
Dapagliflozin Phase II Study Design & Results 77
Overview of Dapagliflozin Registrational Program 78
Dapagliflozin Phase III Study Design (Ongoing) 79
Dapagliflozin Phase III Study Design (Ongoing) 80
Dapagliflozin Phase III Study Design (Ongoing) 81
Dapagliflozin Phase III Study Design (Ongoing) 82
Balaglitazone 83
Balaglitazone Product Overview—Competitor Snapshot 84
Balaglitazone Phase II Study Design & Results 85
Balaglitazone Phase III Study Design (Ongoing) 86
BI-1356 87
BI-1356 Product Overview—Competitor Snapshot 88
BI-1356 Phase I/II Study Design & Results 89
BI-1356 Phase I/II Study Design & Results 90
BI-1356 Phase I/II Study Design (ongoing) 91
BI-1356 Phase III Study Design (Ongoing) 92
BI-1356 Phase III Study Design (Ongoing) 93
BI-1356 Phase III Study Design (Ongoing) 94
BI-1356 Phase III Study Design (Ongoing) 95
BI-1356 Phase III Study Design (Ongoing) 96
rivoglitazone (CS-011) 97
rivoglitazone Product Overview—Competitor Snapshot 98
Rivoglitazone Phase II/III Study Design & Results 99
Rivoglitazone Phase III Study Design (Ongoing) 100
AVE-0010 101
AVE-0010 Product Overview—Competitor Snapshot 102
AVE-0010 Phase IIa Study Design & Results 103
AVE-0010 Phase IIb Study Design 104
AVE-0010 Phase 2b Top-Line Efficacy Results 105
AVE-0010 Product Positioning 106
R1583 107
R1583 Product Overview—Competitor Snapshot 108
R1583 Phase II Study Design & Results 109
R1583 Phase II Study Design & Results 110
R1583 Phase II Study Design & Results 111
R1583 Phase II Study Design & Results 112
AVE-2268 113
AVE-2268 FDC Product Overview—Competitor Snapshot 114
AVE-2268 Phase IIb Study Design 115
remogliflozin 116
Remogliflozin Product Overview—Competitor Snapshot 117
Remogliflozin Phase I Study Design (Ongoing) 118
Remogliflozin Phase I Study Design (Ongoing) 119
Remogliflozin Phase II Study Design (Ongoing) 120
Remogliflozin Phase II Study Design (Ongoing) 121
Remogliflozin Phase II Study Design (Completed) 122
PHX1149 123
PHX1149 Product Overview—Competitor Snapshot 124
PHX1149 Phase I Study Design & Results 125
PHX1149 Phase I Study Design & Results 126
PHX1149 Phase IIa Study Design & Results 127
PHX1149 Phase IIb Study Design (Ongoing) 128
INT131 129
INT131 Product Overview—Competitor Snapshot 130
INT131 Phase I Study Design & Results 131
INT131 Phase I Study Design & Results 132
INT131 Phase IIa Study Design & Results 133
INT131 Phase IIb Study Design (Ongoing) 134
albiglutide 135
albiglutide Product Overview—Competitor Snapshot 136
albiglutide Phase I Study Design 137
albiglutide Phase I Study Design 138
albiglutide Phase I/II Study Design (Ongoing) 139
albiglutide Phase IIb Study Design (Ongoing) 140

Section 4: Long-Term Potential Competitive Threats Innovative Therapies in Mid-Stage Development 141
Aleglitazar 142
Aleglitazar Product Overview—Competitor Snapshot 143
Aleglitazar Phase IIb Study Design (Ongoing) 144
Aleglitazar Phase IIb Study Design (Ongoing) 145
PF-00734200 146
PF-00734200 Product Overview—Competitor Snapshot 147
PF-00734200 Phase IIa Study Design & Results 148
PF-00734200 Phase IIa Study Design (Ongoing) 149
PF-00734200 Phase II Study Design (Ongoing) 150
R1579 151
R1579 Product Overview—Competitor Snapshot 152
R1579 Phase I Study Design & Results 153
R1579 Phase II Study Design (Ongoing) 154
TAK-472 (SYR-472) 155
TAK-472 Product Overview—Competitor Snapshot 156
TAK-472 Phase II Study Design (Ongoing) 157
AMG-222 (ALS 2-0426) 158
AMG-222 Product Overview—Competitor Snapshot 159
INCB13739 160
INCB13739 Product Overview—Competitor Snapshot 161
INCB13739 Phase I Study Design & Results 162
INCB13739 Phase IIa Study Design & Results 163
MB07803 164
MB07803 Product Overview—Competitor Snapshot 165
MB07803 Phase IIa Study Design & Results 166
ISIS 113715 167
ISIS 113715 Product Overview—Competitor Snapshot 168
ISIS 113715 Phase I Study Design & Results 169
ISIS 113715 Phase II Study Design & Results 170
ISIS 113715 Phase II Study Design (Ongoing) 171
AZD2207 172
AZD2207 Product Overview—Competitor Snapshot 173
DIO-902 174
DIO-902 Product Overview—Competitor Snapshot 175
DIO-902 Phase IIa Study Design & Results 176
DIO-902 Phase II/III Study Design (Ongoing) 177
DIO-902 Phase II/III Extension Study Design (Ongoing) 178
EMD 387008 179
EMD 387008 Product Overview—Competitor Snapshot 180
indeglitazar 181
indeglitazar Product Overview—Competitor Snapshot 182
indeglitazar Phase IIa Study Design & Results 183
azilsartan 184
azilsartan Product Overview—Competitor Snapshot 185
MBX-2044 186
MBX-2044 Product Overview—Competitor Snapshot 187
MBX-2044 Phase IIa Study Design & Results 188
CJC-1134-PC 189
CJC-1134-PC Product Overview—Competitor Snapshot 190
CJC-1134-PC Phase I/II Study Design & Results 191
CJC-1134-PC Phase I/II Study Design & Results 192
CJC-1134-PC Phase II Study Design (Ongoing) 193
CJC-1134-PC Phase II Study Design (Ongoing) 194
CRx-401 195
CRx-401 Product Overview—Competitor Snapshot 196
CRx-401 Phase II Study Design (Ongoing) 197
K-111 198
K-111 Product Overview—Competitor Snapshot 199
K-111 Phase IIa Study Design & Results 200
K-111 Phase IIa Study Design & Results 201
MP-513 202
MP-513 Product Overview—Competitor Snapshot 203
MP-513 Phase II Study Design (Ongoing) 204
AKP-020 205
AKP-020 Product Overview—Competitor Snapshot 206
AKP-020 Phase II Study Design (Discontinued) 207
AVE0847 208
AVE0847 Product Overview—Competitor Snapshot 209
AVE0847 Phase II Study Design (Completed-Results Unpublished) 210

Section 6: APPENDIX 211
Disclaimer 212
Report Licensing 213