CLINICAL TRIALS PROFILE FOR METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

All Clinical Trials for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00466518 ↗	Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant	Completed	University of Nebraska	N/A	2007-04-01	This study is designed to look at the effect sitagliptin has on tacrolimus and sirolimus drug levels in kidney transplant patients. It is also designed to look at the side effects experienced in the transplant population.
NCT00466518 ↗	Sitagliptin Treatment in Patients With Type 2 DM After Kidney Transplant	Completed	University of Oklahoma	N/A	2007-04-01	This study is designed to look at the effect sitagliptin has on tacrolimus and sirolimus drug levels in kidney transplant patients. It is also designed to look at the side effects experienced in the transplant population.
NCT01357148 ↗	A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)	Terminated	Merck Sharp & Dohme Corp.		2009-03-01	The primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists, internists, and general practitioners.
NCT03180281 ↗	Therapies on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity Which Protect Islet β Cell	Unknown status	First Affiliated Hospital Xi'an Jiaotong University	N/A	2017-07-01	Prevalence of diabetes is increasing rapidly both in China and all over the world.Hyperglycemia is an important risk factor and major hazard to cardiovascular and cerebrovascular diseases and even dangerous to human health."High glucose toxicity "cause pancreatic β cell non-physiologic and irreversible damage.It is an important cause of β cell dysfunction.High glucose toxicity further suppresses insulin secretion of β cell, further even β-cell function failure.It is urgent to explore more effective and safety treatments which can also protect islet cells function.How to release high glucose toxicity , reverse the toxic effects of hyperglycemia on islet β cells as early as possible, and to maximize recover and protect the pancreatic β cell function is the keypoints of this study.Our aim is to explore the non-inferiority of new antidiabetic drugs DPP4 inhibitors on releasing glucose toxicity and protecting islet β cell function compared with traditional treatments on newly diagnosed type 2 diabetes,compare efficacy and safety of different oral antidiabetic drugs and insulin on newly diagnosed type 2 diabetes patients with high glucose toxicity and compare differences of different oral antidiabetic drugs and insulin on protecting pancreatic β-cell function.
NCT04877106 ↗	Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects	Completed	The Affiliated Hospital of Qingdao University	Phase 1	2018-04-07	An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted in 48 healthy Chinese volunteers under fasted or fed conditions (24 volunteers for each condition) to assess the bioequivalence between two formulations of Sitagliptin Phosphate/metformin Hydrochloride Tablets.
NCT06124495 ↗	Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.	Completed	Galenicum Health	Phase 1	2023-01-13	The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose administration under fasting conditions.
NCT06124547 ↗	Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.	Completed	Galenicum Health	Phase 1	2023-01-16	The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose administration under fed conditions.

Clinical Trial Conditions for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Condition Name

Condition Name for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Intervention	Trials
Diabetes Mellitus, Type 2	5
Bioequivalence	4
Type 2 Diabetes Mellitus	2
Diabetes Mellitus	1

Condition MeSH

Condition MeSH for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Intervention	Trials
Diabetes Mellitus, Type 2	8
Diabetes Mellitus	3

Clinical Trial Locations for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Trials by Country

Trials by Country for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Location	Trials
Mexico	4
China	3
United States	1
Pakistan	1

Trials by US State

Trials by US State for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Location	Trials
Nebraska	1

Clinical Trial Progress for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Clinical Trial Phase

Clinical Trial Phase for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 1	5

Clinical Trial Status

Clinical Trial Status for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Clinical Trial Phase	Trials
COMPLETED	8
Terminated	1
Unknown status	1

Clinical Trial Sponsors for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Sponsor Name

Sponsor Name for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Sponsor	Trials
Galenicum Health	4
University of Lahore	1
University of Nebraska	1

Sponsor Type

Sponsor Type for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Sponsor	Trials
Other	7
Industry	5
NETWORK	1

Clinical Trials Update, Market Analysis, and Forecast for Metformin Hydrochloride and Sitagliptin Phosphate

Last updated: October 29, 2025

---

Introduction

Metformin hydrochloride and sitagliptin phosphate are cornerstone agents in managing type 2 diabetes mellitus (T2DM), a rapidly expanding global health challenge. As innovative developments unfold, a comprehensive review of ongoing clinical trials, market dynamics, and future projections informs stakeholders—from pharmaceutical companies to healthcare providers—about strategic opportunities and risks.

---

Clinical Trials Landscape

Metformin Hydrochloride

Metformin, one of the earliest oral antidiabetics, continues to be scrutinized for expanding therapeutic applications beyond T2DM, including polycystic ovary syndrome (PCOS), weight management, and potential impacts on cardiovascular health.

Recent Clinical Trial Updates:

• Cardiovascular Outcomes: Multiple Phase IV studies are evaluating metformin’s long-term impact on cardiovascular morbidity and mortality among T2DM patients. The EMPA-REG OUTCOME and CAROLINA trials have reinforced its safety profile, leading to expanded indications (e.g., in patients with high cardiovascular risk) [1].

• Combination Therapies: Trials examining synergistic effects with newer agents like SGLT2 inhibitors and GLP-1 receptor agonists are ongoing. For example, a recent multicenter study assesses metformin in combination with empagliflozin for improved glycemic control and weight loss, with promising interim results.

• Adjunctive Use: Investigations into metformin’s potential neuroprotective effects or anti-cancer properties are in early phases, with a focus on molecular mechanisms and clinical endpoints.

Sitagliptin Phosphate

Sitagliptin, a DPP-4 inhibitor introduced in the early 2010s, has seen a steady pipeline of trials assessing efficacy, safety, and expanded indications.

Recent Clinical Trial Updates:

• Cardiovascular Safety & Efficacy: The Sitagliptin Cardiovascular Outcome Trial (TECOS) reaffirmed its safety in reducing cardiovascular events. Subsequent studies are evaluating potential benefits on renal outcomes and heart failure risk.

• Combination Regimens: Multiple phase III trials are exploring sitagliptin combined with sulfonylureas, SGLT2 inhibitors, and insulin analogs, focusing on minimizing hypoglycemia while optimizing glycemic control.

• Novel Indications: Investigations into sitagliptin’s role in non-diabetic conditions such as non-alcoholic fatty liver disease (NAFLD) and obesity suggest a broadening research scope.

Market Analysis

Market Overview & Trends

The global diabetes therapeutics market was valued at approximately USD 61 billion in 2021 and is projected to grow at a CAGR of 8.3% through 2028 [2]. Metformin remains the most prescribed antidiabetic, owing to its efficacy, safety, and cost-effectiveness.

• Market Share: Metformin accounts for over 70% of prescription volume within oral antidiabetics, with a dominating position in both developed and emerging markets.

• Price Dynamics: Generic availability has maintained affordable prices, although patent expirations for some formulations are shifting revenue streams toward biosimilars and combination drugs.

• Sitagliptin Market Penetration: As a branded drug, sitagliptin faced pricing pressures post generic entry; however, its clinical profile sustains strong demand, particularly in markets favoring combination therapy.

Regulatory & Commercial Drivers

• Regulatory Approvals: Expanding indications, especially for cardioprotection and renal benefits, could unlock new markets.

• Patient Demographics: Rising prevalence of T2DM, projected to reach 700 million globally by 2045, sustains strong demand.

• Technological Innovations: Development of fixed-dose combination (FDC) products integrating metformin and sitagliptin enhances patient adherence and market share.

• Emerging Markets: Rapid urbanization and lifestyle changes catalyze market growth in Asia-Pacific, Latin America, and Africa.

Competitive Landscape

• Major players include Merck (Januvia for sitagliptin), AstraZeneca, Novartis, and generic manufacturers.

• Patent cliffs and biosimilar entries threaten sustained profitability for proprietary formulations.

• Innovators are investing in digital health integrations, such as smart pills and monitoring apps, to differentiate offerings.

Future Market Projections

The combined market for metformin and sitagliptin is expected to grow significantly over the next decade.

• Growth Drivers:

  • Increasing global prevalence of T2DM and comorbidities
  • R&D efforts expanding indications
  • Patent expirations fostering generics and biosimilars
  • Rising adoption of combination therapies to improve adherence

• Forecast (2023-2030):

  • The market for combination therapies including metformin and sitagliptin is anticipated to reach USD 8-10 billion by 2030, representing a CAGR of approximately 9% for the combined segment.

• Innovations & Trends:

  • Personalized medicine via pharmacogenomic profiles
  • Integration with digital health platforms
  • Focus on cardio-renal protective agents in therapy pipelines

---

Implications for Stakeholders

Pharmaceutical companies should prioritize clinical trials exploring new indications, especially cardio-renal benefits, to sustain competitive advantage. Regulatory strategies should aim for broader approvals, particularly in emerging markets. Simultaneously, investment in biosimilars and combination products could capture market share lost through patent expirations.

Healthcare providers must stay informed about evolving indications and safety profiles, leveraging real-world evidence to optimize treatment regimens. Policymakers and payers may consider supporting access programs to address the widening prevalence and high costs associated with diabetes management.

---

Key Takeaways

• Clinical research emphasizes expanding indications for metformin and sitagliptin, notably cardiovascular and renal benefits, with ongoing trials potentially reshaping their therapeutic roles.

• Market dynamics are driven by rising diabetes prevalence, patent expirations, and the shift towards combination therapies, with Asia-Pacific and emerging markets exhibiting rapid growth potential.

• Forecasts project the combined market for these drugs will surpass USD 10 billion by 2030, driven by innovation, generic entry, and global health challenges.

• Strategic recommendations include investing in combination products, exploring new indications through clinical trials, and tailoring marketing strategies for high-growth regions.

• Regulatory and reimbursement pathways are evolving to accommodate expanded use cases, necessitating continuous monitoring of policy updates.

---

FAQs

1. What are the primary clinical benefits of combining metformin with sitagliptin?
   Combining these agents improves glycemic control via complementary mechanisms, with metformin reducing hepatic glucose production, and sitagliptin enhancing incretin effects. The combination often results in better adherence due to simplified regimens and reduced hypoglycemia risk.

2. Are there any recent safety concerns with sitagliptin?
   Major safety assessments, including the TECOS trial, indicate sitagliptin is generally well-tolerated. Rare cases of pancreatitis have been reported, prompting ongoing post-market surveillance, but no substantial safety signal has emerged recently.

3. How might upcoming clinical trial outcomes influence regulatory approvals?
   Positive results demonstrating additional benefits, such as cardiovascular or renal protection, could lead to expanded labels, increasing market share and formulary inclusion, especially in high-risk patient populations.

4. What is the impact of patent expirations on market competition?
   Patent expiries allow generic manufacturers to enter the market, reducing prices and increasing accessibility but intensifying competition for established brands. Firms may respond with biosimilars or combination formulations.

5. Will digital health innovations affect the market for these drugs?
   Yes. Integration of digital health tools enhances patient engagement and adherence, potentially improving clinical outcomes and expanding market adoption of combination and monitored therapies.

---

References

[1] European Medicines Agency. (2021). Metformin summary of product characteristics.
[2] Fortune Business Insights. (2022). Diabetes Therapeutics Market Size, Share & Industry Analysis.