Introduction to NESINA
NESINA, also known as alogliptin, is a medication used in the treatment of type 2 diabetes mellitus. It belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors, which work by increasing the levels of incretin hormones, enhancing the release of insulin when glucose levels are elevated, and decreasing the release of glucagon by the pancreas.
Clinical Trials of NESINA
The FDA approval of NESINA was based on several Phase III clinical trials that evaluated its efficacy and safety.
Phase III Clinical Trials
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First Phase III Trial
- Conducted between February 2006 and July 2007, this randomized, multicentre, double-blind, placebo-controlled study enrolled 329 patients with type 2 diabetes. Patients were administered NESINA 12.5mg and 25mg doses or placebo once daily. The primary endpoint was the change in glycosylated hemoglobin (A1C) from baseline after 26 weeks. Results showed significant improvements in A1C and fasting plasma glucose (FPG) in patients treated with NESINA 25mg compared to placebo[3].
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Second Phase III Trial
- This study, conducted between February 2006 and February 2008, enrolled over 655 patients. It compared NESINA 25mg alone, pioglitazone 30mg alone, and combinations of NESINA with pioglitazone. The results demonstrated that the combination of NESINA 25mg and pioglitazone 30mg significantly improved A1C and FPG compared to either drug alone[3].
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Third Phase III Trial
- Conducted between December 2009 and June 2011, this randomized, multicentre, double-blind, placebo-controlled study enrolled about 784 patients. It compared NESINA 12.5mg twice daily, NESINA 25mg daily, metformin, and combinations of NESINA with metformin. The study showed that NESINA, both alone and in combination with metformin, effectively reduced A1C and FPG levels[3].
Additional Clinical Data
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In a pooled analysis of 14 controlled clinical trials involving 14,778 patients, NESINA 25mg demonstrated a favorable safety profile. The overall incidence of adverse reactions was 73% with NESINA, compared to 75% with placebo and 70% with active comparators. Hypoglycemia incidence was low, particularly when NESINA was used as add-on therapy to glyburide or insulin[1].
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The EXAMINE trial, which included patients with high cardiovascular risk, reported that the incidence of investigator-reported hypoglycemia was 6.7% with NESINA and 6.5% with placebo. Serious adverse reactions of hypoglycemia were rare, occurring in 0.8% of patients treated with NESINA and 0.6% of patients treated with placebo[1].
Market Analysis of NESINA
Global Diabetes Care Drugs Market
The global diabetes care drugs market is projected to grow significantly in the coming years.
- By 2025, the market is expected to reach USD 90.60 billion and is anticipated to grow at a CAGR of 3.51% to reach USD 107.66 billion by 2030[5].
Regional Market Trends
- The Asia Pacific region is expected to be the fastest-growing market for diabetes care drugs, while North America holds the largest market share in 2025[5].
Key Players in the Market
- Major companies operating in the diabetes care drugs market include Novo Nordisk, Sanofi, AstraZeneca, Boehringer Ingelheim, and Eli Lilly and Company[5].
Market in Specific Regions
- In Saudi Arabia, the diabetes drug market is valued at around USD 2 billion in 2024 and is projected to reach USD 3.4 billion by 2030, growing at a CAGR of 9% from 2025 to 2030. Key players in this market include Novo Nordisk, Takeda, Pfizer, and others[2].
Market Projections for NESINA
Market Size and Growth
While specific market projections for NESINA are not detailed in the available sources, the drug's performance within the broader DPP-4 inhibitor class can be inferred from the overall market trends.
- Given its efficacy and safety profile, NESINA is likely to maintain a significant share within the DPP-4 inhibitor segment of the diabetes care drugs market.
Distribution Channels
- The distribution of NESINA, like other diabetes medications, is expected to be strong through hospital pharmacies, retail pharmacies, online pharmacies, and clinics and diabetes centers[2].
Key Takeaways
- Clinical Efficacy: NESINA has demonstrated significant improvements in A1C and FPG levels in clinical trials, making it a viable treatment option for type 2 diabetes.
- Safety Profile: The drug has a favorable safety profile, with low incidence of hypoglycemia and comparable adverse reaction rates to placebo and active comparators.
- Market Growth: The global diabetes care drugs market is growing, with the Asia Pacific region expected to be the fastest-growing market.
- Regional Markets: In regions like Saudi Arabia, the diabetes drug market is expanding rapidly, with NESINA likely to benefit from this growth.
FAQs
What is NESINA used for?
NESINA (alogliptin) is used for the treatment of type 2 diabetes mellitus to improve glycemic control.
What are the key findings from the Phase III clinical trials of NESINA?
The Phase III trials showed that NESINA significantly improved A1C and FPG levels when used alone or in combination with other diabetes medications like pioglitazone and metformin.
What is the safety profile of NESINA?
NESINA has a favorable safety profile with a low incidence of hypoglycemia and adverse reaction rates comparable to placebo and active comparators.
How is the global diabetes care drugs market projected to grow?
The global diabetes care drugs market is expected to reach USD 90.60 billion by 2025 and grow at a CAGR of 3.51% to reach USD 107.66 billion by 2030.
Which region is expected to be the fastest-growing market for diabetes care drugs?
The Asia Pacific region is expected to be the fastest-growing market for diabetes care drugs.
What is the projected market size for diabetes drugs in Saudi Arabia by 2030?
The diabetes drug market in Saudi Arabia is projected to reach USD 3.4 billion by 2030, growing at a CAGR of 9% from 2025 to 2030.
Sources
- RxList: Nesina (Alogliptin Tablets): Side Effects, Uses, Dosage...
- MarkNtel Advisors: Saudi Arabia Diabetes Drug Market Size, Share & Trend 2025-2030
- Clinical Trials Arena: Nesina (alogliptin) for Treatment of Type 2 Diabetes Mellitus
- HCPLive: 5 FDA Decisions to Watch in Q1 2025
- Mordor Intelligence: Diabetes Care Drugs Market Share
Last updated: 2025-01-04
