Last Updated: June 10, 2026

CLINICAL TRIALS PROFILE FOR GLIPIZIDE AND METFORMIN HYDROCHLORIDE


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All Clinical Trials for GLIPIZIDE AND 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Condition Name

Condition Name for GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Intervention Trials
Healthy 4
Type 2 Diabetes Mellitus 2
Type 2 Diabetes 2
Arterial Stiffness 1
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Condition MeSH

Condition MeSH for GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Intervention Trials
Diabetes Mellitus 7
Diabetes Mellitus, Type 2 6
Inflammation 1
Hypertension 1
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Clinical Trial Locations for GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Trials by Country

Trials by Country for GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Location Trials
United States 42
Israel 8
Hungary 8
India 7
Mexico 6
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Trials by US State

Trials by US State for GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Location Trials
North Dakota 5
Massachusetts 2
Illinois 2
Minnesota 2
Utah 1
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Clinical Trial Progress for GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 8
Unknown status 3
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Clinical Trial Sponsors for GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Sponsor Trials
Mylan Pharmaceuticals 2
Bristol-Myers Squibb 2
Teva Pharmaceuticals USA 2
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Sponsor Type

Sponsor Type for GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Sponsor Trials
Industry 9
Other 8
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Glipizide and Metformin Hydrochloride: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is the current clinical trial landscape for glipizide plus metformin?

Glipizide plus metformin is an established fixed-dose combination used in type 2 diabetes. For a clinical-trials “update” framed in business-ready terms (study counts, phases, recruitment status, readouts, and timelines), this requires current registry pulls (ClinicalTrials.gov and equivalents), protocol-level endpoints, and sponsor-level status.

That dataset is not provided here; a complete and accurate trial update cannot be produced from the information available in this request alone.

How does the product fit the type 2 diabetes treatment market structure?

Glipizide plus metformin competes in the “oral, add-on after metformin” segment of type 2 diabetes care. The market dynamics are shaped by three forces:

1) Therapeutic migration to incretin-based drugs and SGLT2 inhibitors
Payers and guidelines increasingly prioritize glucose-lowering regimens with proven cardiometabolic benefit in appropriate patient populations. This shifts incremental demand away from older insulin secretagogues and toward newer agents, while preserving oral therapy for cost-sensitive or formulary-constrained settings.

2) Cost and formulary access
Fixed-dose combinations with metformin support low-cost coverage strategies. In markets where budget controls drive prescribing, glipizide-metformin retains value as a step-up therapy.

3) Efficacy and tolerability trade-offs
Sulfonylureas (glipizide) drive glycemic improvement but carry hypoglycemia risk. Metformin anchors therapy with a favorable cost profile and long-standing clinical use.

What is the competitive positioning versus modern oral and injectable classes?

In practical market terms, glipizide-metformin competes against:

  • DPP-4 inhibitors + metformin (moderate efficacy, low hypoglycemia risk)
  • SGLT2 inhibitors + metformin (cardiorenal benefit evidence, higher drug cost)
  • GLP-1 receptor agonists / dual incretins (higher efficacy for weight and glycemic control, route and cost barriers)
  • Basal insulin regimens (effective but often delayed due to burden and hypoglycemia management)

Glipizide-metformin typically wins on price and formulary simplicity, while losing on cardiometabolic outcome signaling and, for many patients, hypoglycemia concerns relative to non-sulfonylurea options.

What market sizing and projection can be stated from provided inputs?

No current market figures, geography scope, or payer-relevant parameters (sales by country, formulary position, segment shares, pricing, or utilization data) are included in the request. Without those inputs, producing a complete and accurate market analysis with quantified projections is not possible.

Accordingly, no numerical market sizing, revenue forecasts, adoption curves, or tranche-level projections can be supplied.

Which product attributes typically drive adoption for glipizide plus metformin?

While precise, current market share requires live data, product-level adoption generally tracks these levers:

  • Fixed-dose convenience: improves adherence versus separate pills.
  • Dose flexibility: supports titration to meet glycemic targets.
  • Safety management: prescribers and patients weigh hypoglycemia risk and dose timing.
  • Formulary tiering: low-cost status often keeps it on preferred lists in cash-pay and budget-limited systems.

What is the most decision-relevant clinical evidence question for this combination today?

For an investment or R&D decision, the key question is whether newer therapeutic standards are displacing sulfonylurea-based combinations or whether they remain clinically used as cost-effective step-up therapy. That determination depends on updated guidelines, real-world prescribing, payer policies, and ongoing trial trends.

A rigorous “clinical trials update” must show:

  • active interventional studies and their status (recruiting, active, completed)
  • endpoints (HbA1c, hypoglycemia rates, weight change, persistence)
  • comparative arms (versus SGLT2, DPP-4, GLP-1, insulin, or metformin alone)
  • readout timing for actionable near-term signals

No registry-level details were provided, so this cannot be executed accurately.

Market projection framework (non-numeric) for defensible planning

Even without numeric forecasts, the directionality for glipizide-metformin typically follows:

1) Stable base demand where metformin remains first-line
When metformin is widely used and inexpensive, add-on oral combinations continue to capture a portion of second-line patients.

2) Share pressure from incretin and SGLT2 classes
As outcome-linked use expands and payers narrow coverage restrictions for sulfonylureas, share erosion can occur even if absolute treated population grows.

3) Geographic dispersion
Markets differ in access and out-of-pocket costs. Low-cost formularies sustain older oral combinations; high-coverage systems with broad access to newer therapies can accelerate substitution.

4) Guideline and reimbursement sensitivity
Updates that emphasize hypoglycemia risk management can reduce sulfonylurea positioning, while cost-effectiveness thresholds can preserve use.

Key Takeaways

  • Glipizide plus metformin is positioned in the cost-sensitive, oral combination segment of type 2 diabetes care.
  • Market headwinds come from incretin-based therapies and SGLT2 inhibitors due to outcome-linked use and formulary migration.
  • A quantified clinical trials update and numerical market projections cannot be produced from the information provided in this request; doing so would require up-to-date trial registry and market/sales/payer data.

FAQs

1) Is glipizide plus metformin still used as second-line therapy?
Yes. It remains a standard oral add-on option in settings where cost and formulary access favor metformin-based combinations.

2) What is the main clinical downside of adding glipizide to metformin?
The main practical risk is hypoglycemia, which affects patient selection and dosing.

3) Do incretin and SGLT2 therapies displace glipizide-metformin?
In higher-access markets and where outcome-linked prescribing is emphasized, they can reduce incremental demand for sulfonylurea combinations.

4) What role does fixed-dose formulation play?
Fixed-dose products often improve adherence versus separate tablets, supporting persistence and glycemic management in routine care.

5) What data is necessary to produce a quantitative trial and market projection?
Trial registry status (study counts and endpoints by phase) and market utilization or sales by geography, payer, and segment.


References

[1] ClinicalTrials.gov. (accessed 2026-04-28).

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