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Research & Reports

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Type 2 Diabetes Inadequately Controlled with Diet and Exercise (First-Line Drug Treatment) | Decision Base | US/EU | 2014

Type 2 Diabetes Inadequately Controlled with Diet and Exercise (First-Line Drug Treatment) | Decision Base | US/EU | 2014

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Affecting more than 30 million people in the United States alone, type 2 diabetes is a critical public health concern. Although diet and exercise are key initial and ongoing management strategies, drug treatment is inevitable for almost all patients. Metformin dominates the first-line drug treatment space, but some patients are unable to take metformin. Moreover, there is a trend way from the traditional stepwise approach to managing type 2 diabetes and toward individualizing therapy. With a broad and increasing range of treatments available, and a growing prevalence of disease, there is significant market opportunity for alternative first-line treatments.

Questions Answered in This Report:

  • A drug’s performance on at least seven efficacy end points, including reduction in glycated hemoglobin (HbA1c) level, is important for drug approval and physician use. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European endocrinologists weight efficacy measures and other drug attributes in their prescribing decisions for patients with type 2 diabetes inadequately controlled with diet and exercise?

  • Greater reduction in body weight, improved effect on beta-cell function, and improved effect on cardiometabolic profile are key areas of unmet need in type 2 diabetes, according to the insights of surveyed U.S. and European endocrinologists. Which therapies in development for type 2 diabetes are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  • Based on its clinical profile, insulin glargine (Sanofi’s Lantus) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge insulin glargine as the future gold standard in 2017 or 2022?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for type 2 diabetes (inadequately controlled with diet and exercise):

- Reduction in HbA1c levels.

- Effect on body weight.

- Incidence of hypoglycemia.

- Incidence of major cardiovascular adverse events.

- Route of administration.

- Dosing frequency.

- Price/day.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for type 2 diabetes (inadequately controlled with diet and exercise):

- Effect on HbA1c levels.

- Effect on body weight.

- Incidence of cardiovascular adverse events.

- Dosing frequency.

Physicians surveyed: 60 U.S. and 31 European endocrinologists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Metformin (Bristol-Myers Squibb/Merck Serono’s Glucophage/Glucophage XR, Depomed/Salix Pharmaceuticals/Valeant Pharmaceutical’s Glumetza, Actavis’s Fortamet, generics)

- Glimepiride (Sanofi’s Amaryl, generics)

- Sitagliptin (Merck’s Januvia/Xelevia)

- Insulin aspart (Novo Nordisk’s NovoLog/Novorapid)

- Insulin glargine (Sanofi’s Lantus)

Emerging Therapies

- Dapagliflozin (Bristol-Myers Squibb/AstraZeneca’s Farxiga/Forxiga)

- Omarigliptin (Merck)

- Albiglutide (GlaxoSmithKline’s Tanzeum [formerly Syncria]/Eperzan)

- Technosphere insulin (MannKind Corporation’s Afrezza)

- Insulin peglispro (Eli Lilly)

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  • Pub Date: May 2014

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