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Type 2 Diabetes Mellitus [2017]

Type 2 Diabetes Mellitus [2017]

Introduction

Will novel therapies transform the treatment of type 2 diabetes?

The treatment of type 2 diabetes mellitus has evolved in recent years with introduction of new classes of molecules. While the wide array of treatment options – including SGLT-2 inhibitors, GLP-1 agonists and newer insulin therapies – provide individualised therapy, unmet needs persist in the market for effective modalities that can provide optimal glycaemic control. Diabetes has a rich late-stage pipeline, but which candidates stand out to key opinion leaders (KOLs)? Which products and combinations are likely to succeed?

Learn how KOLs see the type 2 diabetes market evolving in KOL Insight: Type 2 Diabetes. Twelve US and European KOLs provide candid insights on 18 marketed and 11pipeline therapies targeting various aspects of the type 2 diabetes treatment algorithm.

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The table of contents

The key business questions answered

The key KOL quotes

See the therapies covered

Find out who the 6 EU & 6 US KOLs are

Review an extract from the report - 1 drug profile

Introduction

Reasons to Purchase

Top takeaways

Can Lilly’s once-weekly Trulicity replace Novo Nordisk’s once-daily Victoza as the GLP-1 of choice? Victoza enjoys the dominant position in this class but can newer entrants challenge its dominance?

Can Novo Nordisk’s Xultophy and Sanofi’s Soliqua 100/33, embed themselves in treatment strategy? How do KOLs view these novel once-daily GLP-1/basal insulin combinations?

What do KOLs think of heart failure warnings for AstraZeneca’s Onglyza and Takeda’s Nesina? Do KOLs think signal could be a class-wide effect for DPP-4 inhibitors?

Is there a future for Takeda’s Oseni (alogliptin/pioglitazone) and Kazano (alogliptin/metformin) FDCs? How do KOLs see Oseni’s potential and can Kazano compete with Merck & Co.’s Janumet (sitagliptin/metformin)?

Following positive EMPA-REG OUTCOME data for Boehringer Ingelheim and Eli Lilly’s empagliflozin (Jardiance) can SGLT2 inhibitors move up in the treatment strategy? Can AstraZeneca’s dapagliflozin (Farxiga) compete with Jardiance?

How do KOLs view the novel SGLT2/DPP-4s combinations? Will Glyxambi (empagliflozin/linagliptin; Boehringer Ingelheim/Eli Lilly) and Qtern (dapagliflozin/saxagliptin; AstraZeneca) gain traction in the market?

What potential do KOLs think Novo Nordisk’s basal insulin degludec (Tresiba) and rapid-acting insulin aspart (Fiasp) and basal insulin degludec (Ryzodeg) have? What barriers do they need to be overcome?

How do KOLs rate Novo Nordisk’s injectable once-weekly semaglutide and Intarcia’s ITCA 650 implant? What challenges do KOLs see for these products?

Could Sanofi’s sotagliflozin, Theracos’ bexagliflozin and Pfizer/Merck & Co.’s ertugliflozin provide benefit? Pipeline SGLT2 inhibitors are entering a crowded market, so how do KOLs view their chances of success?

What do KOLs think about Roche’s sinogliatin, a fourth-generation glucokinase activator? How do experts rate this novel mechanism of action in diabetes?

Will PhaseBio’s Insumera provide an attractive proposition or pose more problems than solutions? What do KOLs think of the longer-acting insulin product?

Quote

“I hope there are more comparative studies. They are badly needed; we need to know what kind of drugs work better compared to the others. And more cardiovascular outcome studies, they are even more important than producing ten more drug classes. That’s how I see it.”EU Key Opinion Leader

“We had some significant changes in the past decade with a lot of new categories of molecules and they are going to be part of routine diabetes care in the future. We may see some new drugs which will be competitors to metformin.” EU Key Opinion Leader

Sample of therapies covered

Marketed/Registered Therapies

Farxiga/Forxiga (AstraZeneca/Bristol-Myers Squibb)

Fiasp (Novo Nordisk)

Glyxambi (Boehringer Ingelheim/Eli Lilly)

Invokana (Johnson & Johnson)

Jardiance (Boehringer Ingelheim)

Lyxumia/Adlyxin (Sanofi)

Nesina/Vipidia (Takeda)

Onglyza (AstraZeneca)

Qtern (AstraZeneca)

Ryzodeg (Novo Nordisk)

Synjardy (Boehringer Ingelheim)

Tanzeum/ Eperzan (GlaxoSmithKline)

Toujeo/Optisulin (Sanofi)

Tradjenta/Trajenta (Boehringer Ingelheim/Eli Lilly)

Tresiba (Novo Nordisk)

Trulicity (Eli Lilly)

Xultophy/IDegLira (Novo Nordisk)

Zafatek (Takeda/Furiex)

Aflibercept (Zaltrap; Regeneron/Sanofi)

Bevacizumab (Avastin; Roche)

Ramucirumab (Cyramza; Eli Lilly)

Cetuximab (Erbitux; Eli Lilly/Merck Group)

Panitumumab (Vectibix; Amgen)

Regorafenib (Stivarga; Bayer)

Nivolumab (Opdivo; BMS)

Pembrolizumab (Keytruda; Merck & Co.)

Pipeline Therapies

Atorvastatin/glimepiride (GlaxoSmithKline)

Bexagliflozin (Theracos)

Canagliflozin/teneligliptin (Mitsubishi Tanabe/Daiichi Sankyo)

Ertugliflozin (Pfizer/Merck & Co.)

Insumera (PhaseBio)

Ipragliflozin/sitagliptin (Astellas/Kotobuki/Merck & Co.)

ITCA 650 (Intarcia Therapeutics)

Pioglitazone/linagliptin (Boehringer Ingelheim)

Semaglutide (Novo Nordisk)

Sinogliatin (Roche/Hua Medicine)

Sotagliflozin (Lexicon/Sanofi)

KOLs interviewed

KOLs from North America

Prof. Vivian A. Fonseca, MD, FRCP. Chief, Section of Endocrinology, School of Medicine, Tulane University, New Orleans, LA

Prof. Osama Hamdy, MD, PhD, FACE. Medical Director/Clinical Investigator, Joslin Diabetes Center, Harvard Medical School, Boston, MA

David B. Jack, MD, FAAFP. Adjunct Clinical Faculty, University of Utah School of Medicine and Chair, Board of Trustees, Lone Peak Hospital, Draper, UT

Dr. Udaya M. Kabadi, MD. VA Medical Center, Central Iowa Healthcare System, Des Moines, IA

Dr. Michael Shanik, MD. Endocrinology Diabetes & Metabolism, Catherine of Siena Medical Center and St. Charles Hospital, Smithtown, NY

Prof. Vijay Shivaswamy, MD. Department of Internal Medicine, University of Nebraska Medical Center College of Medicine,Omaha, NE

KOLs from Europe

Prof. Pierre Yves Benhamou, MD, PhD. Professor of Endocrinology and Metabolism, and Head, Clinique d’Endocrinology Diabétology Nutrition, Pôle DIGIDUNE CHU de Grenoble, Université Joseph Fourier, Grenoble, France

Dr Federico Bertuzzi, MD. Medical Director and Consultant, Azienda Ospedaliera Niguarda Ca’ Granda - Unità di diabetologia, Milan, Italy

Prof. Fernando Gomez-Peralta, MD, PhD. Endocrinology and Nutrition Unit, Hospital General De Segovia , Segovia, Spain

Professor Richard Holt MA, MB, BChir, PhD, FRCP, FHEA. Professor in Diabetes and Endocrinology, Department of Medicine, University of Southampton, Southampton, UK

Dr Peter Winocour, MD, FRCP. Consultant Physician, Clinical Director, East and North Hertfordshire NHS Trust, Lister Hospital, Stevenage, UK

German KOL (Anonymous). Prof. Dr. med. and leading diabetologist in Germany

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1. Executive summary
2. Research objectives
3. Research focus
3.1 Epidemiology
3.1.1 Diabetes prevalence
3.2 Diabetes cost burden
3.3 Type 2 diabetes treatment
4. Glucagon-like peptide-1 (GLP-1) agonists
4.1 Overview
4.2 Recently marketed GLP-1 agonists
4.2.1 Lyxumia/Adlyxin (lixisenatide; Sanofi)
4.2.2 Tanzeum/Eperzan (albiglutide; GlaxoSmithKline)
4.2.3 Trulicity (dulaglutide; Eli Lilly)
5. Dipeptidyl peptidase-4 (DPP-4) inhibitors
5.1 Overview
5.2 Recently marketed DPP-4 inhibitors
5.2.1 Onglyza (saxagliptin; AstraZeneca)
5.2.2 Nesina/Vipidia (alogliptin; Takeda)
5.2.3 Tradjenta/Trajenta (linagliptin; Boehringer Ingelheim/Eli Lilly)
5.2.4 Qtern (SaxaDapa, Saxagliptin/Dapagliflozin; AstraZeneca)
5.2.5 Zafatek (trelagliptin; Takeda/Furiex)
6. Sodium-glucose co-transporter-2 (SGLT2) inhibitors
6.1 Overview
6.2 Recently marketed SGLT2 inhibitors
6.2.1 Farxiga/Forxiga (dapagliflozin; AstraZeneca)
6.2.2 Invokana (canagliflozin; Johnson & Johnson)
6.2.3 Jardiance (empagliflozin; Boehringer Ingelheim/Eli Lilly)
7. Insulin therapy
7.1 Overview
7.2 Recently marketed insulins
7.2.1 Tresiba (insulin degludec; Novo Nordisk)
7.2.2 Toujeo/Optisulin (insulin glargine; Sanofi)
7.2.3 Xultophy/IDegLira (insulin degludec/liraglutide; Novo Nordisk)
7.2.4 Ryzodeg (insulin degludec/insulin aspart; Novo Nordisk)
8. Pipeline therapies
8.1 Overview
9. GLP-1 agonists
9.1 Overview
9.1.1 Semaglutide franchise (NN9535 and oral formulation; Novo Nordisk)
10. ITCA 650/exenatide franchise (Intarcia Therapeutics)
10.1 Overview
10.1.1 ITCA 650/exenatide franchise (Intarcia Therapeutics)
11. DPP-4 inhibitors
11.1 Overview
11.1.1 Linagliptin/pioglitazone (Boehringer Ingelheim/Eli Lilly)
12. SGLT2 inhibitors
12.1 Overview
12.1.1 Ertugliflozin franchise (Pfizer/Merck & Co.)
12.1.2 Sotagliflozin (Lexicon Pharmaceuticals/Sanofi)
12.1.3 Bexagliflozin (Theracos)
13. Other mid- to late-stage agents
13.1 Overview
13.1.1 Atorvastatin/glimepiride (GlaxoSmithKline)
13.1.2 Sinogliatin (Roche/Hua Medicine)
13.1.3 Insumera (PE0139; PhaseBio Pharmaceuticals)
14. Conclusion
14.1 Current and future treatment algorithm
15. Appendix
15.1 KOL details
15.1.1 KOLs from North America
15.1.2 KOLs from the EU

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