Compared with Current and Emerging Non-Insulin Therapies, Does Metformin’s Clinical Profile Justify Its Dominant Position in Recommended Treatment Guidelines?

Affecting 30 million people in the Unites 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. Due to the progressive nature of type 2 diabetes, insulin therapy is often required as a “last resort” therapeutic option for the treatment of this disease. Prior to the use of insulin, however, there are a number of non-insulin-based therapies that can be employed as effective therapies. Due to its prominent position in treatment guidelines, metformin (Bristol-Myers Squibb/Merck Serono’s Glucophage/Glucophage XR, Salix’s Glumetza, Shionogi’s Fortamet, generics) is most frequently the first-line drug therapy used in the treatment of type 2 diabetes. While metformin has demonstrated efficacy and safety as a treatment option for type 2 diabetes, its use as a first-line agent is often driven by its low cost and it may not be the best therapeutic option for certain patients. There is an increasing move toward individualizing therapy, which may lead physicians to seek alternatives to metformin as potential non-insulin therapeutic options for treatment of type 2 diabetes. With a broad and increasing range of treatments available and a growing prevalence of disease, there is a significant market opportunity for alternative non-insulin treatments.

Questions Answered in This Report:

  • A drug’s performance on at least seven efficacy end points, including reduction in glycated hemoglobin (HbA1c), 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 type 2 diabetes?

  • Metformin was the most-prescribed non-insulin therapy used in the treatment of type 2 diabetes in 2013. What weaknesses exist in its profile that would allow emerging therapies to gain a foothold in the market? Have emerging therapies demonstrated strengths on the attributes that surveyed endocrinologists indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed managed care organization pharmacy directors (MCO PDs) seek from new therapies?

  • Based on its clinical profile, dulaglutide (Eli Lilly’s Trulicity) 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 dulaglutide as the future gold standard in 2018 or 2023?


Attributes included in conjoint analysis-based assessment of target product profiles for type 2 diabetes:

- 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:

- Effect on HbA1c levels

- Effect on body weight

- Incidence of cardiovascular adverse events

- Dosing frequency

Physicians surveyed: 64 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, Salix’s Glumetza, Shionogi’s Fortamet, generics)

- Sitagliptin (Merck & Co.’s Januvia/Xelevia; Ono’s Glactiv)

- Liraglutide (Novo Nordisk’s Victoza)

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

- Dulaglutide (Eli Lilly’s Trulicity)

- Glimepiride (Sanofi’s Amaryl, generics)

Emerging Therapies

- Omarigliptin (Merck)

- ITCA-650 (Intarcia Therapeutics/Servier)

- Oral semaglutide (Novo Nordisk)

- Saxagliptin/dapagliflozin (AstraZeneca)

Related Reports

Type 2 Diabetes - Landscape & Forecast - Disease Landscape & Forecast

View Details

Type 2 Diabetes | Disease Landscape and Forecast | G7 | 2020

The type 2 diabetes therapy market will steadily expand over the 2019-2029 study period, fueled by increasing prevalence and high unmet need for drugs that can effectively control the disease in th...

View Details

Type 2 Diabetes - Epidemiology - Extrapolated Worldwide Coverage

DRG’s Extrapolated Worldwide Coverage is the first and only evidence-based data set of epidemiological forecasts for key type 2 diabetes patient...

View Details

Type 2 Diabetes - Current Treatment - Detailed, Expanded Analysis: Treatment Algorithms: Claims Data Analysis (US) Dashboard

Metformin and sulfonylureas are the most heavily prescribed type 2 diabetes drugs and dominate the early lines of therapy, before disease progression requires insulin replacement. The emergence of...

View Details