CLINICAL TRIALS PROFILE FOR GLIPIZIDE; METFORMIN HYDROCHLORIDE

All Clinical Trials for Glipizide; Metformin Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00513630 ↗	Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease	Completed	Shanghai Jiao Tong University School of Medicine	Phase 4	2004-06-01	The purpose of this study is to explore the recurrence risk of cardiovascular events in patients with type 2 diabetes mellitus and coronary heart disease after different antidiabetic drug therapy (glipizide or metformin) by using an double-blind, randomized, parallel control and prospective study The end point of this study is: 1. follow up 3yr 2. recurrence of cardiovascular event 3. death caused by other reasons such as stroke, uremia, blindness and amputation
NCT00648505 ↗	Food Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg	Completed	Mylan Pharmaceuticals	Phase 1	2005-06-01	The objective of this study was to investigate the bioequivalence of Mylan's glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fed conditions.
NCT00649454 ↗	Fasting Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg	Completed	Mylan Pharmaceuticals	Phase 1	2005-06-01	The objective of this study was to investigate the bioequivalence of Mylan's glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fasting conditions.
NCT00660907 ↗	Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients	Completed	Bristol-Myers Squibb	Phase 3	2008-03-01	This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.
NCT00660907 ↗	Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients	Completed	AstraZeneca	Phase 3	2008-03-01	This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.
NCT00696982 ↗	The Effect of Sitagliptin on Hypertension, Arterial Stiffness, Oxidative Stress and Inflammation	Unknown status	Assaf-Harofeh Medical Center	N/A	2008-06-01	Recently a new category of antihyperglycemic therapy aiming to modulate the incretin system has emerged. These drugs induce insulin secretion without inducing hypoglycemia. The effect of the incretin modulators drugs on hypertension, arterial stiffness, inflammation and oxidative stress parameters have not been fully investigated yet.GLP-1 analogue has been suggested to have an effect on endothelium and the development of hypertension. Nystrom et al have demonstrated that GLP-1 improves endothelial dysfunction in a small group of type 2 diabetes subjects, with coronary heart disease. We hypothesize that DPP-4 inhibitor will have an effect on hypertension and arterial stiffness by effect on the NO pathway.The aim of this study is to investigate the effect of two insulin inducers drugs, sulfonyl urea and DPP-4 inhibitor on 24 hours blood pressure monitoring, arterial stiffness, oxidative stress and inflammation.

Clinical Trial Conditions for Glipizide; Metformin Hydrochloride

Condition Name

Condition Name for Glipizide; Metformin Hydrochloride
Intervention	Trials
Healthy	4
Type 2 Diabetes	2
Type 2 Diabetes Mellitus	2
Arterial Stiffness	1

Condition MeSH

Condition MeSH for Glipizide; Metformin Hydrochloride
Intervention	Trials
Diabetes Mellitus	7
Diabetes Mellitus, Type 2	6
Coronary Disease	1
Hyperglycemia	1

Clinical Trial Locations for Glipizide; Metformin Hydrochloride

Trials by Country

Trials by Country for Glipizide; Metformin Hydrochloride
Location	Trials
United States	42
Israel	8
Hungary	8
India	7
Mexico	6

Trials by US State

Trials by US State for Glipizide; Metformin Hydrochloride
Location	Trials
North Dakota	5
Minnesota	2
Massachusetts	2
Illinois	2
Colorado	1

Clinical Trial Progress for Glipizide; Metformin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Glipizide; Metformin Hydrochloride
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 1	5

Clinical Trial Status

Clinical Trial Status for Glipizide; Metformin Hydrochloride
Clinical Trial Phase	Trials
Completed	8
Unknown status	3

Clinical Trial Sponsors for Glipizide; Metformin Hydrochloride

Sponsor Name

Sponsor Name for Glipizide; Metformin Hydrochloride
Sponsor	Trials
Mylan Pharmaceuticals	2
Bristol-Myers Squibb	2
Teva Pharmaceuticals USA	2

Sponsor Type

Sponsor Type for Glipizide; Metformin Hydrochloride
Sponsor	Trials
Industry	9
Other	8

GLIPIZIDE; METFORMIN HYDROCHLORIDE: Clinical Trials Update, Market Analysis, and Projections

Last updated: April 25, 2026

What is the current clinical-trials landscape for glipizide + metformin?

Glipizide and metformin are widely marketed as separate and as combination products in multiple countries. Public clinical-trials activity for the specific fixed-dose combination is generally sparse compared with trials for metformin monotherapy, metformin-based regimens, or trials involving newer add-on agents. Trial participation and endpoints commonly center on glycemic control in type 2 diabetes (T2D), safety/tolerability, and comparative effectiveness against other oral antidiabetic strategies.

Observed pattern in registries (industry-standard structure):

• Interventional studies: often randomized comparisons where metformin is the background therapy, with glipizide used as one comparator arm or as part of a titration strategy.
• Real-world and post-marketing: common where fixed-dose or regimen equivalence is evaluated in routine care settings.
• Longer follow-up: typically focuses on HbA1c, hypoglycemia rates, weight change, and adherence.

Practical implication for investors and R&D planners

• For a combination-centric R&D thesis, the competitive benchmark is usually not “new phase-3 efficacy” but rather bioequivalence, formulation, and comparative effectiveness work that can support line extensions, generic lifecycle management, and payer access.
• If a program claims differentiation (faster onset, reduced hypoglycemia, improved adherence), the evidence package usually needs to show advantage on at least one of:
  • Hypoglycemia incidence (glipizide-related)
  • HbA1c change under standardized titration
  • Adherence metrics or refill persistence for fixed-dose regimens

Because this request requires a specific, up-to-date clinical-trials update (study titles, NCT identifiers, dates, statuses, arms, endpoints), and because that depends on live registry reads, a complete and accurate update cannot be produced from static knowledge alone.

What is the market positioning for glipizide + metformin?

The combination sits in the mature oral antidiabetic segment: T2D standard-of-care pricing pressure is high, and incremental value depends on formulary placement, dosing convenience, and hypoglycemia risk management.

Therapy class and demand drivers

• Metformin is the foundational first-line drug in many guidelines.
• Glipizide is a second-line sulfonylurea used when glycemic targets are not met with metformin alone.

Demand is driven by:

• T2D prevalence and diagnosis rates
• Continued metformin adoption (including generics)
• Cost-sensitive prescribing for intensification when HbA1c remains above target
• Formulary inclusion of combination tablets versus switching to separate generic components

Competitive set

The combination faces substitution from:

• Metformin + other sulfonylureas (e.g., glyburide in some markets)
• Metformin + DPP-4 inhibitors
• Metformin + SGLT2 inhibitors
• Metformin + GLP-1 receptor agonists
• Metformin + thiazolidinediones
• Metformin + newer combination fixed-dose tablets

Where the glipizide + metformin bundle retains share

• Payer systems that emphasize lowest net cost per HbA1c unit
• Regions where sulfonylureas remain preferred intensification options
• Patients stable on sulfonylurea therapy with established tolerability

How should the revenue and unit outlook be projected for this drug combination?

A projection for a specific fixed-dose combination requires baseline:

• country-by-country sales or prescriptions,
• market share across brand and generic,
• product-level penetration by strength and formulation,
• patent and exclusivity windows,
• and expected competitive shifts from newer drug classes.

A complete and accurate projection cannot be produced without verifiable current sales, prescription volumes, and launch-specific data for the specific branded fixed-dose combination(s) in the relevant geographies.

What do typical commercial and reimbursement dynamics imply for the next 3–7 years?

Even without product-level sales figures, the commercial mechanics for this class are stable and govern outcomes:

1) Pricing and margin pressure

• Metformin and sulfonylureas are generic in most markets.
• Fixed-dose combinations compress price as payers incentivize lower-cost multi-drug regimens.
• Expect net price pressure versus branded add-ons (DPP-4, SGLT2, GLP-1).

2) Uptake is tied to formulary and persistence

• Fixed-dose combinations win when they improve adherence or reduce regimen complexity.
• Hypoglycemia risk management affects prescribing patterns; prescribers may avoid higher-risk patients or titrate conservatively.

3) Switching behavior

• Patients often move away from sulfonylureas when SGLT2/GLP-1 become affordable or preferred on formularies.
• However, in budget-constrained settings, sulfonylurea intensification remains durable.

Can lifecycle changes (formulation, BE, new strengths) create measurable upside?

For mature generic molecules, “R&D” frequently converts into:

• fixed-dose formulation optimization,
• improved dissolution or release profile,
• new strengths for titration (lower starting strengths to reduce early hypoglycemia risk),
• and bioequivalence packages enabling market entry in new countries.

Upside channels

• Geographic expansion
• Strength/pack optimization for payer contracts
• Line extensions replacing separate tablets with combination SKUs

What are the key watch items for competitive risk in glipizide + metformin?

1. Guideline and formulary shifts favoring SGLT2/GLP-1 classes over sulfonylureas
2. Hypoglycemia safety scrutiny that affects prescriber willingness to intensify with sulfonylureas
3. Patent cliff dynamics for any branded fixed-dose combination (if applicable in specific jurisdictions)
4. Generic entry waves for combination tablets and strength-specific SKUs
5. Supply-chain and manufacturing quality for generic consolidation risk

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Key Takeaways

• Glipizide + metformin is a mature, cost-sensitive intensification option within T2D oral therapy, with clinical evidence generally anchored to glycemic control and hypoglycemia risk under titration.
• The clinical-trials “update” for the fixed-dose combination is usually limited in volume versus metformin-centric or newer add-on trials; most incremental development is formulation and comparative evidence.
• Market outlook is driven by generic pricing pressure, formulary placement, and substitution from SGLT2/GLP-1 classes.
• A defensible numeric market projection requires product- and geography-specific sales/prescription baselines and trial registry reads; those cannot be generated accurately from static input.

FAQs

1) Is there ongoing phase-3 development for the fixed-dose glipizide + metformin combination?
Publicly available development activity tends to be more limited for the fixed-dose combination than for metformin-based regimens and newer add-on classes.

2) What endpoints matter most for new combination filings?
HbA1c change, hypoglycemia incidence, and tolerability are the core clinical endpoints; for many lifecycle filings, bioequivalence and pragmatic adherence outcomes become central.

3) How does hypoglycemia risk influence prescribing?
Sulfonylureas increase hypoglycemia risk, so clinicians titrate conservatively and may preferentially switch to other add-on classes if formulary and patient factors allow.

4) What substitutes most directly compete with glipizide + metformin?
Metformin combinations with DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, and other sulfonylurea pairings are the main substitution vectors.

5) What commercial levers create value for mature generics?
Geographic expansion, improved strength/pack configurations, fixed-dose adherence advantages, and payer contracting tied to net price.

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References

[1] American Diabetes Association. Standards of Care in Diabetes. (Latest edition).
[2] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (glipizide and metformin; combination products by active ingredient).
[3] ClinicalTrials.gov. glipizide metformin combination (public registry search results).