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
Kidney Transplant	1
Type 2 Diabetes	1

Condition MeSH

Condition MeSH for Metformin Hydrochloride; Sitagliptin Phosphate
Intervention	Trials
Diabetes Mellitus, Type 2	7
Diabetes Mellitus	2

Clinical Trial Locations for Metformin Hydrochloride; Sitagliptin Phosphate

Trials by Country

Trials by Country for Metformin Hydrochloride; Sitagliptin Phosphate
Location	Trials
Mexico	4
China	2
United States	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
Phase 1	5
N/A	2

Clinical Trial Status

Clinical Trial Status for Metformin Hydrochloride; Sitagliptin Phosphate
Clinical Trial Phase	Trials
Completed	6
Unknown status	1
Terminated	1

Clinical Trial Sponsors for Metformin Hydrochloride; Sitagliptin Phosphate

Sponsor Name

Sponsor Name for Metformin Hydrochloride; Sitagliptin Phosphate
Sponsor	Trials
Galenicum Health	4
The Affiliated Hospital of Qingdao University	1
University of Nebraska	1

Sponsor Type

Sponsor Type for Metformin Hydrochloride; Sitagliptin Phosphate
Sponsor	Trials
Industry	5
Other	4

Metformin Hydrochloride and Sitagliptin Phosphate: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Metformin hydrochloride and sitagliptin phosphate are two crucial medications in the management of type 2 diabetes mellitus. This article delves into the recent clinical trials, market analysis, and future projections for these drugs, highlighting their efficacy, safety, and market dynamics.

Clinical Efficacy and Safety of Metformin Hydrochloride

Recent Clinical Trials

A significant clinical trial compared the efficacy and safety of metformin hydrochloride sustained-release (SR) tablets with the original metformin hydrochloride tablets produced by Glucophage. This randomized, open, and parallel controlled clinical trial involved 886 patients with type 2 diabetes mellitus (T2DM) over 16 weeks. The results showed that both forms of metformin effectively reduced fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) levels, with comparable efficacy. Additionally, both forms significantly reduced body weight in patients, and the incidence of adverse gastrointestinal reactions was low[4].

Pharmacokinetic Studies

Pharmacokinetic studies have also been conducted to compare the bioequivalence of metformin hydrochloride with other formulations. A study involving 28 healthy Chinese subjects compared the pharmacokinetic profiles of metformin hydrochloride under fasting and fed states. The results indicated that the geometric mean ratios of maximum serum concentration (Cmax) and area under the concentration-time curve (AUC) for metformin were within the acceptance limits, confirming bioequivalence[3].

Clinical Efficacy and Safety of Sitagliptin Phosphate

Combination Therapy with Metformin

Sitagliptin phosphate, often combined with metformin hydrochloride in the form of Janumet, has shown significant clinical efficacy. Janumet works by combining the glucose-lowering effects of metformin, which decreases glucose production in the liver and absorption by the intestines, with sitagliptin, which regulates insulin levels produced after eating. This combination is used with diet and exercise to improve blood sugar control in adults with T2DM[5].

Pharmacokinetic Comparison

A pharmacokinetic comparison study of sitagliptin and metformin hydrochloride under fasting and fed states showed that the geometric mean ratios of Cmax and AUC for sitagliptin were within the acceptance limits, indicating bioequivalence. The study also noted that the pharmacokinetic profiles of sitagliptin and metformin were similar between the test and reference drugs, with slight variations in Cmax and AUC under different states[3].

Market Analysis for Metformin Hydrochloride

Global Market Size and Growth

The global metformin hydrochloride market was valued at approximately USD 268.95 million in 2022 and is projected to grow to USD 386.91 million by 2030, with a compound annual growth rate (CAGR) of 4.7% between 2023 and 2030. This growth is driven by the increasing prevalence of type 2 diabetes, particularly in the Asia-Pacific region[1].

Market Segmentation

The market is segmented based on application, distribution channel, and region. The immediate release segment has shown the highest growth due to its effectiveness and convenience. The Asia-Pacific region is expected to lead the market during the forecast period, driven by the high prevalence of type 2 diabetes in countries like China and India[1].

Market Analysis for Sitagliptin Phosphate and Combination Therapies

Combination Anti-Diabetes Drugs Market

The Combination Anti-Diabetes Drugs Market, which includes Janumet (a combination of metformin and sitagliptin), is expected to reach USD 1.09 billion in 2024 and grow at a CAGR of 10.87% to reach USD 1.85 billion by 2029. Janumet holds the highest market share in this segment, approximately 37.4%, due to its efficacy in controlling blood sugar levels[5].

Key Players

The market for sitagliptin phosphate and metformin hydrochloride combination therapies involves several key players, including MSD Merck Sharp & Dohme AG, Shanghai Anbisheng Pharmaceutical Technology Co. Ltd, and Huahai Pharmaceutical Co., Ltd. These companies are driving innovation and accessibility in the diabetes treatment market[2].

Future Projections and Trends

Increasing Prevalence of Type 2 Diabetes

The growing number of people living with type 2 diabetes, especially in Asia-Pacific, is expected to drive the demand for metformin hydrochloride and sitagliptin phosphate. Lifestyle changes, population growth, and an aging population are contributing factors to this trend[1].

Research and Development

Ongoing research into the potential benefits of metformin beyond diabetes treatment, such as its cardiovascular benefits and possible anti-aging effects, is likely to further boost its market. Studies investigating its role in reducing the risk of cancer, stroke, and dementia in patients with type 2 diabetes are also underway[1].

Cost-Effectiveness and Accessibility

The development of more affordable forms of these drugs, as highlighted in pharmacokinetic studies, will make them more accessible to a broader population, contributing to market growth[3].

Key Takeaways

• Clinical Efficacy: Both metformin hydrochloride and sitagliptin phosphate have shown significant efficacy in managing type 2 diabetes, with comparable safety profiles.
• Market Growth: The global metformin hydrochloride market is projected to grow at a CAGR of 4.7% from 2023 to 2030, while the Combination Anti-Diabetes Drugs Market, including Janumet, is expected to grow at a CAGR of 10.87% from 2024 to 2029.
• Market Leaders: The Asia-Pacific region is expected to lead the metformin hydrochloride market, and Janumet holds the highest market share in the combination anti-diabetes drugs segment.
• Future Trends: Increasing prevalence of type 2 diabetes, ongoing research into additional benefits of metformin, and the development of more affordable drug forms are key drivers of future market growth.

FAQs

What is the projected market size for metformin hydrochloride by 2030?

The global metformin hydrochloride market is predicted to grow to around USD 386.91 million by 2030[1].

Which region is expected to lead the metformin hydrochloride market?

The Asia-Pacific region is expected to lead the metformin hydrochloride market during the forecast period due to the high prevalence of type 2 diabetes in countries like China and India[1].

What is the market share of Janumet in the Combination Anti-Diabetes Drugs Market?

Janumet holds the highest market share of about 37.4% in the Combination Anti-Diabetes Drugs Market[5].

What are the potential additional benefits of metformin hydrochloride being researched?

Studies are investigating the potential benefits of metformin hydrochloride in reducing the risk of cancer, stroke, and dementia, as well as its anti-aging effects[1].

Which companies are key players in the sitagliptin phosphate and metformin hydrochloride market?

Key players include MSD Merck Sharp & Dohme AG, Shanghai Anbisheng Pharmaceutical Technology Co. Ltd, and Huahai Pharmaceutical Co., Ltd.[2].

Sources

1. Zion Market Research: Metformin Hydrochloride Market Size, Share and Forecast 2030.
2. Valuates Reports: Sitagliptin Phosphate And Metformin Hydrochloride Tablets(Ⅱ) Market.
3. Frontiers in Pharmacology: Pharmacokinetic comparison of sitagliptin and metformin HCl.
4. Frontiers in Endocrinology: Comparison of Clinical Efficacy and Safety of Metformin Sustained Release Tablets.
5. Mordor Intelligence: Combination Anti-Diabetes Drugs Market Size & Share Analysis.