DecisionBase

November 2013

Type 2 Diabetes

Introduction:

When Metformin Has Lost the Battle for Glycemic Control, What Antidiabetic Agents Win Endocrinologists' Backing?

Metformin is well established as the first-line treatment of choice for type 2 diabetes, along with dietary and exercise interventions. Owing to the progressive nature of the disease, patients typically lose glycemic control after a period of time despite treatment. Drug failure requires more antidiabetic drugs to be added to the treatment regimen to regain glycemic control.  Although sulfonylureas have historically been the standard second-line treatment, there are concerns about these drugs’ safety profile. As the range of treatments available continues to grow and the benefits of individualizing therapy are recognized, prescribers and payers face increasingly challenging decisions regarding second-line antidiabetic agents.

Questions Answered in This Report:

  *   A drug’s performance on at least seven efficacy end points, including reduction in 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 on metformin?

  *   Greater reduction in body weight and lower incidence of hypoglycemia are key areas of unmet need in the treatment of patients with type 2 diabetes inadequately controlled on metformin, 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 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?

  *   Reduction in HbA1c levels and effect on body weight are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new type 2 diabetes therapies. What trade-offs across these and other clinical attributes are U.S. endocrinologists willing to make when considering the use of emerging therapies for type 2 diabetes? Based on the trade-offs in price and performance across key drug attributes that U.S. endocrinologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for type 2 diabetes?

  *   Based on its clinical profile, liraglutide (Novo Nordisk’s Victoza) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current and emerging therapies? Will any therapies in development challenge liraglutide as the future gold standard in 2016 or 2021?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for treating patients with type 2 diabetes inadequately controlled on metformin:

- Reduction in HbA1c levels.

- Reduction in fasting plasma glucose levels.

- Effect on body weight.

- Incidence of hypoglycemia.

- Route of administration.

- Dosing frequency.

- Price per day.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for type 2 diabetes inadequately controlled with metformin:

- Effect on HbA1c levels.

- Effect on percentage of patients achieving HbA1c < 7.0%.

- Effect on body weight.

- Incidence of hypoglycemia.

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

Payers surveyed: 20 U.S. MCO pharmacy directors.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Sitagliptin (Merck’s Januvia/Xelevia)

- Pioglitazone (Takeda’s Actos, generics)

- Liraglutide (Novo Nordisk’s Victoza)

- Long-acting-release (LAR) exenatide (Bristol-Myers Squibb/AstraZeneca’s Bydureon)

- Glimepiride (Sanofi’s Amaryl, generics)

Emerging Therapies

- Canagliflozin (Johnson & Johnson/Mitsubishi Tanabe Pharma’s Invokana)

- Lixisenatide (Sanofi/Zealand Pharma’s Lyxumia)

- Dulaglutide (Eli Lilly)

- Fasiglifam (Takeda)

- Omarigliptin (Merck)


Search Reports

Mentioned in this report:

  • - AstraZeneca
  • - Bristol-Myers Squib
  • - Boehringer Ingelheim
  • - Eli Lilly
  • - Johnson & Johnson
  • - Merck & Co.
  • - Mitsubishi Tanabe Pharma
  • - Novo Nordisk
  • - Sanofi
  • - Takeda Pharmaceuticals
  • - Zealand Pharma
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