CLINICAL TRIALS PROFILE FOR METFORMIN HYDROCHLORIDE; SITAGLIPTIN

All Clinical Trials for Metformin Hydrochloride; Sitagliptin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00103857 ↗	MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2005-03-17	The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).
NCT00337610 ↗	Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-06-01	A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.
NCT00350779 ↗	Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-06-12	A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome proliferator-activated receptor gamma (PPARg) agonist combination therapy.
NCT00395343 ↗	Sitagliptin Added-on to Insulin Study (0431-051)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-12-11	A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin combination therapy.
NCT00420511 ↗	Beta-Cell Function and Sitagliptin Trial (BEST)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2007-01-01	Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a double-blind, randomized controlled pilot study comparing the effect of sitagliptin (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM on metformin, the first-line agent for the treatment of T2DM (ie. the study groups will be (i) sitagliptin and metformin versus (ii) placebo and metformin). This study may demonstrate an important beta-cell protective capacity of sitagliptin. Hypothesis: In patients with T2DM on metformin, treatment with the DPP-IV inhibitor sitagliptin will preserve pancreatic beta-cell function.
NCT00420511 ↗	Beta-Cell Function and Sitagliptin Trial (BEST)	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	Phase 2	2007-01-01	Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a double-blind, randomized controlled pilot study comparing the effect of sitagliptin (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM on metformin, the first-line agent for the treatment of T2DM (ie. the study groups will be (i) sitagliptin and metformin versus (ii) placebo and metformin). This study may demonstrate an important beta-cell protective capacity of sitagliptin. Hypothesis: In patients with T2DM on metformin, treatment with the DPP-IV inhibitor sitagliptin will preserve pancreatic beta-cell function.
NCT00449930 ↗	Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2007-03-01	A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes

Clinical Trial Conditions for Metformin Hydrochloride; Sitagliptin

Condition Name

Condition Name for Metformin Hydrochloride; Sitagliptin
Intervention	Trials
Type 2 Diabetes Mellitus	64
Diabetes Mellitus, Type 2	48
Type 2 Diabetes	34
Diabetes	13

Condition MeSH

Condition MeSH for Metformin Hydrochloride; Sitagliptin
Intervention	Trials
Diabetes Mellitus, Type 2	149
Diabetes Mellitus	146
Polycystic Ovary Syndrome	4
Non-alcoholic Fatty Liver Disease	4

Clinical Trial Locations for Metformin Hydrochloride; Sitagliptin

Trials by Country

Trials by Country for Metformin Hydrochloride; Sitagliptin
Location	Trials
United States	695
China	58
Canada	55
Mexico	48
India	47

Trials by US State

Trials by US State for Metformin Hydrochloride; Sitagliptin
Location	Trials
Texas	39
California	39
Florida	36
Ohio	29
North Carolina	26

Clinical Trial Progress for Metformin Hydrochloride; Sitagliptin

Clinical Trial Phase

Clinical Trial Phase for Metformin Hydrochloride; Sitagliptin
Clinical Trial Phase	Trials
Phase 4	57
Phase 3	68
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Metformin Hydrochloride; Sitagliptin
Clinical Trial Phase	Trials
Completed	150
Unknown status	12
Recruiting	9

Clinical Trial Sponsors for Metformin Hydrochloride; Sitagliptin

Sponsor Name

Sponsor Name for Metformin Hydrochloride; Sitagliptin
Sponsor	Trials
Merck Sharp & Dohme Corp.	61
Novo Nordisk A/S	10
AstraZeneca	7

Sponsor Type

Sponsor Type for Metformin Hydrochloride; Sitagliptin
Sponsor	Trials
Industry	153
Other	87
NIH	3

Clinical Trials, Market Analysis, and Projections for Metformin Hydrochloride and Sitagliptin

Introduction to Metformin Hydrochloride and Sitagliptin

Metformin hydrochloride and sitagliptin are two widely used medications in the management of type 2 diabetes. Metformin is a first-line treatment for type 2 diabetes, while sitagliptin is often used as an adjunct therapy. Here, we will delve into the clinical trials, market analysis, and projections for these drugs.

Clinical Trials: Efficacy and Safety of Metformin and Sitagliptin

Combination Therapy Trials

Several clinical trials have evaluated the efficacy and safety of combining metformin and sitagliptin. A notable study involved a 24-week, randomized, double-blind, placebo-controlled trial where patients with type 2 diabetes were treated with various combinations of sitagliptin and metformin. The results showed that all active treatments produced statistically significant reductions in A1C levels compared to placebo. The combination of sitagliptin and metformin demonstrated an additive effect, with the coadministration groups showing greater reductions in A1C than the respective monotherapies[1].

Another study, conducted over 54 weeks, further supported the efficacy of this combination. It found that sitagliptin in combination with metformin had additive efficacy over a 104-week follow-up period. However, there was a slightly higher rate of hypoglycemic adverse events reported with the combination of sitagliptin and metformin compared to either drug alone[3].

Pharmacokinetic Studies

Pharmacokinetic studies have also been conducted to compare the profiles of sitagliptin and metformin when administered together. A study involving healthy Chinese subjects found that the pharmacokinetic parameters of sitagliptin and metformin, including maximum serum concentration (Cmax) and area under the concentration-time curve (AUC), were within acceptable limits when administered together, both in fasting and fed states. This indicates that the combination does not significantly alter the pharmacokinetics of either drug[4].

Market Analysis for Metformin Hydrochloride

Current Market Size and Growth

The global metformin hydrochloride market was valued at approximately USD 268.95 million in 2022. It 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. The market is segmented based on application, distribution channel, and region, with the immediate release segment showing the highest growth due to its effectiveness and convenience[2].

Regional Market Trends

The Asia-Pacific region is expected to lead the global metformin hydrochloride market during the forecast period. This is driven by the high prevalence of type 2 diabetes in countries like China and India, where over 140 million people in China and 135 million people in India were diagnosed with diabetes or prediabetes as of 2021. The increasing population, aging demographics, and adoption of inactive lifestyles further contribute to the growing demand for metformin hydrochloride in this region[2].

Market Analysis for Sitagliptin

Current Market Size and Growth

The global sitagliptin market is estimated to be USD 6914.5 million in 2024 and is projected to expand at a CAGR of 35.20% from 2024 to 2031, reaching USD 57,094.94 million by 2031. The US holds a significant share of the market, while the Asia-Pacific region, particularly China, is also a major contributor due to the rising prevalence of type 2 diabetes[5].

Regional Market Trends

The Asia-Pacific region holds around 23% of the global sitagliptin market revenue, with a market size of USD 1590.34 million in 2024. This region is expected to grow at a CAGR of 37.2% from 2024 to 2031. Other regions, such as Latin America and the Middle East and Africa, also show significant growth potential, driven by increasing awareness and advancements in diabetes management[5].

Projections and Future Outlook

Increasing Prevalence of Diabetes

The growing global prevalence of type 2 diabetes is a key driver for the markets of both metformin hydrochloride and sitagliptin. As the number of diagnosed cases continues to rise, the demand for effective oral treatments is expected to increase. Factors such as an aging population, sedentary lifestyles, and rising obesity rates contribute to the expanding market for these medications[2][5].

Advancements in Diabetes Management

Advancements in diabetes management, including personalized healthcare approaches and improved diagnostic tools, are expected to further boost the adoption of metformin hydrochloride and sitagliptin. The convenience and effectiveness of these medications, particularly in combination therapy, make them preferred treatment options for healthcare providers[1][5].

Key Takeaways

• Clinical Efficacy: Combination therapy with metformin and sitagliptin shows additive efficacy in reducing A1C levels, with a slightly higher risk of hypoglycemic adverse events.
• Market Growth: The global metformin hydrochloride market is projected to grow at a CAGR of 4.7% from 2023 to 2030, while the sitagliptin market is expected to grow at a CAGR of 35.20% from 2024 to 2031.
• Regional Trends: The Asia-Pacific region is a significant market for both drugs due to the high prevalence of type 2 diabetes.
• Future Outlook: The increasing prevalence of diabetes and advancements in diabetes management are key drivers for the growing demand for these medications.

FAQs

Q: What is the primary benefit of combining metformin and sitagliptin in diabetes treatment?

The primary benefit is the additive efficacy in reducing A1C levels, providing better glycemic control compared to monotherapy.

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

The global metformin hydrochloride market is projected to reach approximately USD 386.91 million by 2030.

Q: Which region is expected to lead the global sitagliptin market?

The US currently holds a significant share, but the Asia-Pacific region is also a major contributor and is expected to continue growing.

Q: What are the key drivers for the growth of the sitagliptin market?

The key drivers include the increasing prevalence of type 2 diabetes, advancements in diabetes management, and growing awareness about effective treatment options.

Q: Are there any notable side effects associated with the combination of metformin and sitagliptin?

Yes, there is a slightly higher rate of hypoglycemic adverse events reported with the combination compared to either drug alone.

Sources

1. Effect of Initial Combination Therapy With Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, and Metformin on Glycemic Control in Patients With Type 2 Diabetes. Diabetes Care, 2007.
2. Metformin Hydrochloride Market Size, Share and Forecast 2030. Zion Market Research.
3. Australian public assessment for Sitagliptin / Metformin. Therapeutic Goods Administration, 2013.
4. Pharmacokinetic comparison of sitagliptin and metformin HCl in healthy Chinese subjects: A randomized, open-label, two-period crossover study. Frontiers in Pharmacology, 2023.
5. Global Sitagliptin Market Report 2024. Cognitive Market Research.