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CLINICAL TRIALS PROFILE FOR JANUMET XR

All Clinical Trials for janumet xr

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00532935 ↗	MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2008-01-26	A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes
NCT00684528 ↗	A Double-Blind, Randomized, Active-Comparator (Metformin) Controlled, Clinical Trial to Study the Efficacy and Safety of the Strategy to Start Patients With Type 2 Diabetes Mellitus on Janumet™ Compared to Metformin	Unknown status	Clalit Health Services	Phase 3	2008-06-01	Comparison between the effectiveness of one anti-diabetic drug (Metformin, To combination of this drug and additional drug (Janufer), In the community setting.
NCT00684528 ↗	A Double-Blind, Randomized, Active-Comparator (Metformin) Controlled, Clinical Trial to Study the Efficacy and Safety of the Strategy to Start Patients With Type 2 Diabetes Mellitus on Janumet™ Compared to Metformin	Unknown status	Meir Medical Center	Phase 3	2008-06-01	Comparison between the effectiveness of one anti-diabetic drug (Metformin, To combination of this drug and additional drug (Janufer), In the community setting.
NCT00993187 ↗	Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2010-05-04	This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior reduction in HbA1c (mean change from baseline) compared to glimepiride.
NCT01065766 ↗	Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)	Completed	Merck Sharp & Dohme Corp.		2009-03-01	This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
NCT01269996 ↗	JanUmet Before Insulin Lantus In Eastern Population Evaluation Program (JUBILEE) In Type 2 Diabetic Patients	Completed	Chinese University of Hong Kong	Phase 4	2011-05-01	To evaluate the efficacy and safety of a new treatment regimen of metformin plus sitagliptin (Janumet) followed by a long-acting basal insulin (Lantus) treatment compared to the usual treatment regimen of metformin followed by sulfonylurea and intermediate-acting basal insulin in Type 2 Diabetes Mellitus patients.

Clinical Trial Conditions for janumet xr

Condition Name

Condition Name for janumet xr
Intervention	Trials
Type 2 Diabetes Mellitus	6
Diabetes Mellitus, Type 2	6
Bioequivalence	4
Type 2 Diabetes	2

Condition MeSH

Condition MeSH for janumet xr
Intervention	Trials
Diabetes Mellitus, Type 2	14
Diabetes Mellitus	10
Polycystic Ovary Syndrome	2
Body Weight	1

Clinical Trial Locations for janumet xr

Trials by Country

Trials by Country for janumet xr
Location	Trials
United States	9
Canada	5
Mexico	5
Israel	2
Germany	2

Trials by US State

Trials by US State for janumet xr
Location	Trials
Michigan	1
Georgia	1
Texas	1
Florida	1
Colorado	1

Clinical Trial Progress for janumet xr

Clinical Trial Phase

Clinical Trial Phase for janumet xr
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for janumet xr
Clinical Trial Phase	Trials
Completed	17
Terminated	1
Unknown status	1

Clinical Trial Sponsors for janumet xr

Sponsor Name

Sponsor Name for janumet xr
Sponsor	Trials
Merck Sharp & Dohme Corp.	9
Galenicum Health	4
Emory University	1

Sponsor Type

Sponsor Type for janumet xr
Sponsor	Trials
Industry	16
Other	13

Janumet xr Market Analysis and Financial Projection

JANUMET XR: Clinical Trials, Market Analysis, and Projections

Introduction to JANUMET XR

JANUMET XR is a combination medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes. It combines sitagliptin, the active component of JANUVIA, with extended-release metformin hydrochloride (HCl). This formulation offers a convenient once-daily treatment option for patients needing to control their blood sugar levels.

Clinical Trials and Efficacy

The FDA approval of JANUMET XR was based on a clinical bioequivalence study that demonstrated its equivalence to the co-administration of the individual medications, sitagliptin and extended-release metformin HCl. This study showed that the extended-release formulation of metformin was as effective as the immediate-release form[1].

Pharmacokinetic Studies

Recent pharmacokinetic studies have compared the profiles and safety of JANUMET XR with other formulations. These studies, conducted under fasting and fed states, used an open, randomized, two-period crossover design. The results indicated that JANUMET XR had comparable pharmacokinetic profiles to the reference drug, ensuring its safety and efficacy[4].

Common Adverse Effects

Clinical trials have identified hypoglycemia as one of the most frequently observed adverse effects (AEs) associated with JANUMET XR. Other potential side effects include gastrointestinal issues, which can be mitigated by gradual dose titration[4].

Market Analysis

Market Share and Sales

JANUMET XR, along with its predecessor JANUMET, holds a significant market share in the combination anti-diabetes drugs market. As of recent data, JANUMET commands approximately 37.4% of this market. The annual sales of JANUMET XR were $734 million in 2021, with peak sales reaching $1.1 billion in 2018[2][5].

Competitive Edge

The drug maintains its market share due to its expanded indications and strong brand presence. Merck, the manufacturer, continues to pursue approvals in emerging markets, including certain African geographies, although these markets are currently relatively small in terms of revenue impact[3].

Patent and Regulatory Protections

JANUMET XR is protected by one US patent and two FDA regulatory exclusivities. The earliest estimated date for generic entry is May 24, 2027, although this could change due to patent challenges or generic licensing agreements[2].

Market Projections

Generic Entry and Competition

The potential for generic entry in 2027 is expected to impact the market dynamics of JANUMET XR. However, several factors, including new patent filings, patent extensions, and early generic licensing, could influence the actual timing of generic entry. This competition is likely to reduce the market share and sales revenue of JANUMET XR once generics become available[2].

Global Sales Forecast

Despite the impending generic competition, JANUMET XR is expected to continue generating significant revenue in the short term. The drug's strong brand presence and ongoing efforts to expand into new markets will help maintain its market position until generic alternatives become widely available.

Emerging Markets

Merck is actively pursuing approvals and expanding the reach of JANUMET XR into emerging markets. While these markets are currently small, they are expected to grow in importance over the long term, contributing to the drug's continued relevance and sales[3].

Conclusion

JANUMET XR remains a powerful and convenient treatment option for patients with type 2 diabetes, offering once-daily dosing and effective blood sugar control. Its strong market presence and ongoing efforts to expand into new markets ensure its continued relevance, despite the looming threat of generic competition.

Key Takeaways

• Clinical Efficacy: JANUMET XR is clinically bioequivalent to the co-administration of sitagliptin and extended-release metformin HCl.
• Market Share: JANUMET XR holds a significant market share in the combination anti-diabetes drugs market.
• Sales Revenue: Annual sales were $734 million in 2021, with peak sales of $1.1 billion in 2018.
• Patent Protections: Protected by one US patent and two FDA regulatory exclusivities until May 24, 2027.
• Generic Entry: Expected generic entry in 2027 could impact market dynamics.
• Emerging Markets: Ongoing efforts to expand into emerging markets will contribute to long-term sales.

FAQs

What is JANUMET XR used for?

JANUMET XR is used for the treatment of type 2 diabetes, combining sitagliptin and extended-release metformin hydrochloride to help control blood sugar levels.

What are the common side effects of JANUMET XR?

Common side effects include hypoglycemia and gastrointestinal issues, which can be mitigated by gradual dose titration.

When is the earliest estimated date for generic entry of JANUMET XR?

The earliest estimated date for generic entry is May 24, 2027, although this could change due to various factors.

How does JANUMET XR compare to other diabetes treatments?

JANUMET XR offers a convenient once-daily dosing option and is clinically bioequivalent to the co-administration of its individual components.

What is the current market share of JANUMET XR in the anti-diabetes drugs market?

JANUMET XR, along with JANUMET, commands approximately 37.4% of the combination anti-diabetes drugs market.

Sources

1. FDA Approves JANUMET® XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes - Merck.
2. JANUMET XR Drug Patent Profile - DrugPatentWatch.
3. Brand of the Year: Januvia - Pharmaceutical Executive.
4. Pharmacokinetic comparison of sitagliptin and metformin HCl extended-release tablets - Frontiers in Pharmacology.
5. JANUMET Drug Patent Profile - DrugPatentWatch.