CLINICAL TRIALS PROFILE FOR REPAGLINIDE AND METFORMIN HYDROCHLORIDE

All Clinical Trials for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00118950 ↗	Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet	Completed	Steno Diabetes Center	Phase 4	2001-03-01	Background: Metformin is the first drug of choice in obese patients with type-2 diabetes (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In non-obese T2DM patients insulin-secretagogues are empirically used as first choice. The aim of this study was to evaluate the effect of metformin versus an insulin-secretagogue, repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in non-obese patients with T2DM. Methods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96 non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d). followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months with a one month wash-out between interventions.
NCT00118950 ↗	Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet	Completed	Steno Diabetes Center Copenhagen	Phase 4	2001-03-01	Background: Metformin is the first drug of choice in obese patients with type-2 diabetes (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In non-obese T2DM patients insulin-secretagogues are empirically used as first choice. The aim of this study was to evaluate the effect of metformin versus an insulin-secretagogue, repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in non-obese patients with T2DM. Methods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96 non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d). followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months with a one month wash-out between interventions.
NCT00118963 ↗	Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes	Completed	Steno Diabetes Center	Phase 4	2003-01-01	Aim: The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular events in obese patients with type-2-diabetes treated with metformin compared with other hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of cardiovascular events, the use of metformin for this sub-group of patients might be more beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence exist for choosing the optimal class of OHA to be combined with insulin. The aim of the project is therefore to investigate the effect of metformin vs. an insulin-secretagogue (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone. Methodology: Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart 30/70, BIAsp30) for a period of 12 months.
NCT00118963 ↗	Effect of Repaglinide Versus Metformin Treatment in Non-Obese Patients With Type-2-Diabetes	Completed	Steno Diabetes Center Copenhagen	Phase 4	2003-01-01	Aim: The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular events in obese patients with type-2-diabetes treated with metformin compared with other hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of cardiovascular events, the use of metformin for this sub-group of patients might be more beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence exist for choosing the optimal class of OHA to be combined with insulin. The aim of the project is therefore to investigate the effect of metformin vs. an insulin-secretagogue (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone. Methodology: Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart 30/70, BIAsp30) for a period of 12 months.
NCT00399711 ↗	Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes	Completed	Novo Nordisk A/S	Phase 3	2006-11-01	This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.

Clinical Trial Conditions for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Condition Name

Condition Name for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus, Type 2	16
Diabetes	11
Type 2 Diabetes	3
Chronic Kidney Disease	1

Condition MeSH

Condition MeSH for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus, Type 2	19
Diabetes Mellitus	16
Renal Insufficiency, Chronic	1
Kidney Diseases	1

Clinical Trial Locations for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Trials by Country

Trials by Country for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Location	Trials
United States	41
China	14
United Kingdom	2
Belgium	2
Denmark	2

Trials by US State

Trials by US State for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Location	Trials
Florida	3
New York	2
Georgia	2
Texas	2
Pennsylvania	1

Clinical Trial Progress for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	18
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Sponsor	Trials
Novo Nordisk A/S	12
Steno Diabetes Center	2
Steno Diabetes Center Copenhagen	2

Sponsor Type

Sponsor Type for REPAGLINIDE AND METFORMIN HYDROCHLORIDE
Sponsor	Trials
Industry	16
Other	15

Last updated: May 2, 2026

Repaglinide and Metformin Hydrochloride: Clinical Trials Update, Market Analysis, and Projections

What is repaglinide plus metformin in the market context?

Repaglinide and metformin hydrochloride is a fixed-dose combination used in type 2 diabetes management. The clinical and commercial value proposition centers on improved glycemic control versus monotherapy and the ability to manage insulin secretagogue dosing with metformin’s insulin-sensitizing effect. Commercially, this combination competes in the established oral diabetes segment against other dual therapies and fixed-dose combinations (FDCs).

This analysis focuses on the therapeutic area (type 2 diabetes, oral combination therapy), the clinical-development signal from registered trials, and the commercial outlook implied by the established and mature nature of these molecules.

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What does the clinical trials landscape look like?

There is no single, unified global “latest phase” register position that captures every repaglinide/metformin FDC under one product moniker across jurisdictions because trials are filed by molecule, combinations, and local product brands. The practical read-through for investors is the presence or absence of active late-stage development and the intensity of comparative studies in real-world settings.

Clinical trial activity signals to track (what matters for valuation):

• Phase 3 / late-stage confirmatory studies: upgrades in label scope (for example, new patient populations, new dosing regimens, or new endpoint strategy).
• Bioequivalence and formulation studies: common in off-patent or lifecycle management phases, including country-to-country product registrations.
• Comparative effectiveness trials: head-to-head comparisons versus other oral dual regimens (often in pragmatic designs).

What the current state implies (market-impact perspective):

• Repaglinide and metformin are established generics in most markets, so new clinical filings are typically not aimed at de novo global label expansion in Phase 3.
• Clinical activity tends to cluster around formulation, dosing optimization, and comparative effectiveness rather than transformative efficacy trials.

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Which clinical trial endpoints dominate for this combination?

Across diabetes combination development and lifecycle studies, endpoints usually include:

• HbA1c change from baseline (primary or key secondary)
• Fasting plasma glucose (FPG) and post-prandial glucose (PPG
• Responder analyses (HbA1c targets achieved)
• Safety and tolerability focused on:
  • Hypoglycemia risk (repaglinide-driven)
  • Gastrointestinal adverse events (metformin-driven)
  • Weight change and treatment adherence signals

Business interpretation: for an established oral combo, endpoint strategy typically targets label consistency, demonstrate non-inferiority to reference regimens, or meet regulatory requirements for FDC registrations rather than creating new treatment classes.

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What is the market size context for repaglinide-metformin combination therapy?

The combination sits inside the much larger type 2 diabetes oral therapy market, which is dominated by:

• Biguanides (metformin)
• Sulfonylureas and insulin secretagogues (repaglinide in this class)
• Fixed-dose combinations

Key market dynamics that govern projections:

1. Generic-driven pricing pressure
   • Repaglinide and metformin are mature molecules.
   • FDC products, where marketed, face price compression as generics expand.
2. Shift of prescribers toward newer classes
   • GLP-1 receptor agonists and SGLT2 inhibitors capture higher-end prescribing share in many geographies for cardiovascular/renal benefit.
   • Oral dual therapy still maintains large baseline volume because it is cost-effective and easy to use, especially where newer agents are restricted by reimbursement.
3. Regional differentiation in adoption
   • Uptake depends on reimbursement policy and formulary placement for fixed-dose combinations.

Commercial bottom line: repaglinide-metformin is likely to remain a “volume asset” rather than a premium-priced growth engine.

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How is competitive positioning shaping demand?

Primary competitive sets:

• Other fixed-dose metformin dual therapies (metformin plus DPP-4 inhibitors in some markets; metformin plus sulfonylureas in others)
• Metformin + insulin secretagogues delivered as separate tablets or alternative FDCs

Repaglinide-specific considerations:

• Repaglinide’s short-acting insulin secretagogue profile supports dosing tied to meals, which can align with real-world adherence for some patients.
• Hypoglycemia risk shapes prescriber and patient preference, particularly in older cohorts or those with variable meal timing.

Business implication: market share is sensitive to local clinical guidelines, formulary rules, and provider comfort with hypoglycemia management.

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What does a market projection model look like for an established FDC?

A credible projection for repaglinide-metformin should use a “mature category” framework:

• Forecast volume using:
  • Type 2 diabetes prevalence and diagnosed population growth
  • Treatment initiation rates for oral dual therapy
  • Switching rates out of oral therapy into newer injectables/orals
• Forecast price using:
  • Generic erosion rates
  • Competitive FDC availability
  • Reimbursement-driven net price pressure

Expected pattern for 3 to 5 year outlook (directional):

• Volume: modest growth or stable growth, supported by large treated patient base
• Value: slower growth than volume due to sustained price compression
• Net CAGR: typically low single digits in value for mature generics, unless a specific jurisdiction restricts supply or reimbursement favors branded FDCs

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What are the main drivers of growth or decline?

Growth drivers

• Continued reliance on cost-effective oral therapy in mid-income and cost-constrained reimbursement environments
• Formulary inclusion as a low-cost dual option
• Patient adherence benefits from fixed-dose convenience where available

Decline drivers

• Formulary shifts toward GLP-1 and SGLT2 classes where reimbursement is generous
• Increasing clinician preference for therapies with demonstrated cardiovascular and renal outcomes
• Generic intensity reducing branded premium (if applicable) and compressing net pricing

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What does this mean for R&D investment strategy?

For a mature FDC, the highest ROI development paths are usually:

• Regulatory lifecycle actions (bioequivalence, bridging, stability)
• Dose regimen optimization to improve tolerability or meal-time adherence
• Pragmatic comparative studies to support formulary value in specific payer systems
• Targeted subpopulation safety focus (hypoglycemia risk management)

Transformative Phase 3 programs are less likely unless a company identifies a defensible label expansion opportunity tied to measurable clinical outcomes or a distinctive population.

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What should investors watch in the next clinical cycle?

Key signals that would change the market outlook:

• Active late-stage filings that expand indications, revise dosing strategy, or establish non-inferiority against newer comparator regimens
• Evidence of improved safety through formulation or dosing changes that materially reduce hypoglycemia or GI intolerance
• Geographic expansion through new FDC registrations that widen payer access

Absent those signals, the default model remains mature-category behavior: volume stability with price pressure.

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Key Takeaways

• Repaglinide plus metformin is an established type 2 diabetes oral combination with mature molecule status, which tends to drive generic pricing pressure and lifecycle-focused clinical activity rather than transformative Phase 3 innovation.
• Clinical trial activity is expected to concentrate on bioequivalence/formulation and comparative effectiveness evidence rather than new label-defining efficacy breakthroughs.
• Market value growth should track modest volume gains offset by sustained net price erosion and competitive substitution from newer diabetes classes in geographies with strong reimbursement support.
• Investor-impact developments are likely to come from jurisdiction-specific formulary wins, new registrations, or label-supporting clinical evidence that changes prescribing behavior or payer coverage.

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FAQs

1) Is repaglinide-metformin likely to see major Phase 3 label expansion globally?

In most markets, the combination’s mature status typically limits late-stage label expansion. When new studies occur, they often support lifecycle registrations or regimen positioning rather than new therapeutic categories.

2) What is the biggest safety driver for this combination?

Hypoglycemia risk, which aligns with repaglinide’s mechanism, is usually the dominant safety concern to manage in clinical use; metformin contributes gastrointestinal tolerability constraints.

3) How does competition from GLP-1 and SGLT2 therapies affect the outlook?

It tends to shift incremental prescribing away from older oral dual therapy, especially where reimbursement favors cardiovascular and renal outcome-linked agents.

4) What market factor can improve revenues even with generics pressure?

Wider formulary access or reimbursement preference for a specific fixed-dose product in cost-constrained systems can lift net volumes enough to partly offset price declines.

5) What trial evidence is most valuable for payers in this segment?

Pragmatic comparative data and tolerability-focused evidence that can be translated into reduced adverse event burden and improved adherence typically carry higher payer weight than incremental glycemic changes alone.

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References (APA)

No sources were cited because the prompt did not provide enough factual anchors (for example, registries, publication links, or jurisdictional product patent status) to produce an accurate, citation-backed clinical trials update and market projection for this specific combination.