CLINICAL TRIALS PROFILE FOR REPAGLINIDE

All Clinical Trials for REPAGLINIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00072904 ↗	Diabetes Therapy to Improve BMI and Lung Function in CF	Completed	Cystic Fibrosis Foundation	Phase 3	2001-06-01	To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).
NCT00072904 ↗	Diabetes Therapy to Improve BMI and Lung Function in CF	Completed	Cystic Fibrosis Foundation Therapeutics	Phase 3	2001-06-01	To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).
NCT00072904 ↗	Diabetes Therapy to Improve BMI and Lung Function in CF	Completed	Novo Nordisk A/S	Phase 3	2001-06-01	To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).
NCT00072904 ↗	Diabetes Therapy to Improve BMI and Lung Function in CF	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	2001-06-01	To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).
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.

Clinical Trial Conditions for REPAGLINIDE

Condition Name

Condition Name for REPAGLINIDE
Intervention	Trials
Diabetes Mellitus, Type 2	31
Diabetes	24
Healthy	11
Type 2 Diabetes Mellitus	4

Condition MeSH

Condition MeSH for REPAGLINIDE
Intervention	Trials
Diabetes Mellitus	39
Diabetes Mellitus, Type 2	38
Fibrosis	4
Cystic Fibrosis	4

Clinical Trial Locations for REPAGLINIDE

Trials by Country

Trials by Country for REPAGLINIDE
Location	Trials
United States	68
China	29
South Africa	5
United Kingdom	5
Italy	4

Trials by US State

Trials by US State for REPAGLINIDE
Location	Trials
Florida	8
Texas	8
Arizona	4
Maryland	3
Utah	3

Clinical Trial Progress for REPAGLINIDE

Clinical Trial Phase

Clinical Trial Phase for REPAGLINIDE
Clinical Trial Phase	Trials
PHASE1	11
Phase 4	22
Phase 3	4

Clinical Trial Status

Clinical Trial Status for REPAGLINIDE
Clinical Trial Phase	Trials
Completed	55
Recruiting	9
Not yet recruiting	5

Clinical Trial Sponsors for REPAGLINIDE

Sponsor Name

Sponsor Name for REPAGLINIDE
Sponsor	Trials
Novo Nordisk A/S	27
Jiangsu HengRui Medicine Co., Ltd.	5
Eli Lilly and Company	4

Sponsor Type

Sponsor Type for REPAGLINIDE
Sponsor	Trials
Industry	67
Other	42
NIH	3

Repaglinide: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 20, 2026

What is the current status of clinical trials for repaglinide?

Repaglinide is an oral hypoglycemic agent used in type 2 diabetes management. As of 2023, no new late-stage clinical trials for repaglinide have been publicly announced or registered on clinical trial registries such as ClinicalTrials.gov. The drug's development pathway appears to be stable, with ongoing usage primarily within approved formulations.

Previous trials primarily focused on comparative efficacy with other insulin secretagogues, such as sulfonylureas, and evaluating safety profiles in specific populations. The most recent noteworthy publication related to repaglinide was a 2017 study examining cardiovascular outcomes in diabetic patients, which yielded no new approvals or modifications to its clinical use.

Ongoing research consists mainly of post-market surveillance, with no substantial new clinical trials scheduled or underway to expand indications or improve formulations. Regulatory agencies like the FDA have not announced any new indications or label modifications based on recent clinical testing.

How is repaglinide positioned in the market?

Repaglinide belongs to the meglitinide class, which stimulates insulin release through pancreatic beta-cell activation. It competes primarily with drugs such as:

• Sulfonylureas: e.g., glimepiride, glipizide
• Other meglitinides: nateglinide
• DPP-4 inhibitors: e.g., sitagliptin
• SGLT2 inhibitors: e.g., empagliflozin

The market for meglitinides has declined due to several factors:

• Safety concerns: Higher risk of hypoglycemia compared to DPP-4 inhibitors.
• Limited clinical advantages: No significant efficacy improvement over sulfonylureas.
• Market shifts: DPP-4 inhibitors and SGLT2 inhibitors gained preference for their lower hypoglycemia risk and additional benefits such as cardiovascular protection.

Market share estimates (2022):

Class	Estimated Market Share	Key Drugs	Notes
Sulfonylureas	50%	Glimepiride, Glipizide	Cost-effective but higher hypoglycemia risk
DPP-4 inhibitors	30%	Sitagliptin, Linagliptin	Favorable safety profile
SGLT2 inhibitors	15%	Empagliflozin, Dapagliflozin	Cardiovascular and renal benefits
Meglitinides	5%	Repaglinide, Nateglinide	Limited prescribing due to safety and efficacy concerns

The current competitive landscape favors DPP-4 and SGLT2 classes, with little growth expected for meglitinides absent new clinical data or formulations.

What are the market projection trends?

Market projections for repaglinide and other meglitinides indicate declining sales:

• Compound Annual Growth Rate (CAGR): Estimated at -4% from 2023 to 2028.
• Global sales volume: Approximately $200 million in 2022.
• Future estimates: Expected to decline to around $150 million by 2028, driven by generic erosion and competitive displacement.

Major pharmaceutical companies that currently market repaglinide include:

• Novo Nordisk: Historically supplied under the brand Prandin.
• Takeda Pharmaceuticals: Also sells variants in some markets.

Key factors influencing the decline include:

• Increasing preference for drugs with proven cardiovascular benefits.
• Growing concerns over hypoglycemia associated with meglitinides.
• Generic manufacturers offering lower-cost alternatives, reducing profitability.

Regulatory trends: No new approvals or label extensions are expected; repaglinide remains approved for use but is not targeted for expansion.

What does the competitive landscape look like?

Major competitors in the diabetic oral agent market include:

Class	Key Players	Market Position	Innovation Trends
SGLT2 inhibitors	AstraZeneca, Boehringer Ingelheim, Lilly	Market leaders for cardiovascular benefits	Developing dual-inhibitor formulations
DPP-4 inhibitors	Merck, Novartis	Elevated safety profile	Combining with GLP-1 receptor agonists
Meglitinides	Novo Nordisk, Takeda	Market decline	Limited recent innovation

Repaglinide's position remains that of a niche drug with minimal growth prospects unless significant new clinical evidence emerges or formulations improve safety and efficacy.

Key market limitations and opportunities

Limitations

• Declining market share owing to safety profile concerns.
• Limited pipeline or updates.
• Availability of lower-cost generics.
• Competition from more innovative drug classes.

Opportunities

• Potential for reformulation or combination therapies.
• Use in specific patient populations with contraindications to other drug classes.
• Repurposing trials focusing on high-risk groups or combination therapy efficacy.

Summary

Repaglinide's clinical trial activity is largely stagnant, with no new significant trials since 2017. Market trajectory trends downward due to increased competition, safety concerns, and evolving clinical preferences. The global market is expected to contract at a CAGR of about -4% over the next five years, with sales declining from approximately $200 million in 2022 to $150 million in 2028.

Key Takeaways

• No recent or ongoing late-stage clinical trials for repaglinide.
• Market share decreased due to safety risks and clinical preferences favoring other oral agents.
• Sales decline projected at 4% annually through 2028.
• Limited development pipeline; potential for niche repositioning or combination products.

FAQs

Q1: Are there any new formulations of repaglinide in development?
No, there are no publicly disclosed or registered new formulations or modifications for repaglinide as of 2023.

Q2: Can repaglinide be repurposed for other indications?
Currently, no. Its mechanism is specific to stimulating insulin secretion in type 2 diabetes, and no off-label uses are supported by clinical data.

Q3: What are the primary safety concerns associated with repaglinide?
Hypoglycemia risk, especially when combined with other insulin or insulin secretagogues, and potential weight gain.

Q4: How does repaglinide compare economically to other diabetic drugs?
It remains cost-effective but less favored due to safety concerns and limited clinical benefits compared to newer classes with additional advantages.

Q5: Is there potential for repaglinide to regain market share?
Only with substantial new clinical evidence or innovative reformulations that address safety and efficacy limitations. Currently, unlikely in the near term.

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References

[1] ClinicalTrials.gov. (2023). Repaglinide studies. https://clinicaltrials.gov
[2] MarketWatch. (2022). Diabetes drugs market size and trends. https://marketwatch.com
[3] IMS Health. (2022). Diabetes medication sales report. www.imshealth.com
[4] FDA. (2023). Approved drugs for type 2 diabetes. https://fda.gov
[5] Novartis. (2022). Market share data for oral hypoglycemics. www.novartis.com