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
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.
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.

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

Condition MeSH

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

Clinical Trial Locations for REPAGLINIDE AND METFORMIN HYDROCHLORIDE

Trials by Country

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

Trials by US State

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

Repaglinide and Metformin Hydrochloride: A Comprehensive Overview

Introduction

Repaglinide and metformin hydrochloride are two potent antidiabetic drugs often combined to manage type 2 diabetes mellitus. This article delves into the clinical trials, market analysis, and projections for this combination therapy, providing a detailed insight into its efficacy, safety, and market dynamics.

Clinical Trials and Efficacy

Combination Therapy

The combination of repaglinide and metformin hydrochloride is designed to leverage the strengths of both drugs. Repaglinide, a meglitinide, rapidly stimulates insulin release from the pancreas, making it effective for controlling postprandial hyperglycemia. Metformin, a biguanide, reduces glucose production in the liver and increases insulin sensitivity[1][4].

Clinical trials have shown that this combination is effective in patients who are inadequately controlled with either repaglinide or metformin alone. The recommended starting dose is typically 1 mg repaglinide/500 mg metformin hydrochloride, administered twice daily with meals, with gradual dose escalation based on glycemic response to minimize the risk of hypoglycemia and gastrointestinal side effects[1][4].

Safety Profile

The safety profile of repaglinide and metformin hydrochloride combination therapy has been extensively studied. Common adverse reactions include hypoglycemia, headache, and gastrointestinal reactions such as diarrhea, nausea, and vomiting. However, there is no conclusive evidence of macrovascular risk reduction with this combination[4].

Lactic Acidosis Risk with Metformin

A significant concern with metformin is the risk of lactic acidosis, although extensive studies have shown that metformin does not increase this risk when used appropriately. A comprehensive analysis of 194 studies revealed no cases of fatal or nonfatal lactic acidosis in patients treated with metformin, indicating a very low incidence rate[3].

Market Analysis

Market Size and Growth

The market for repaglinide is projected to grow significantly, driven by the increasing global prevalence of type 2 diabetes. The repaglinide market was valued at USD 85 billion in 2023 and is expected to reach USD 109 billion by 2031, growing at a CAGR of 3.6% from 2024 to 2031[2].

Key Drivers

Several factors are driving the growth of the repaglinide and metformin hydrochloride market:

• Increasing Prevalence of Type 2 Diabetes: The global rise in type 2 diabetes cases is a primary driver, as more patients require effective glucose-lowering drugs[2][5].
• Quick Action and Short Half-Life: Repaglinide's rapid onset and brief duration make it a preferred choice for managing postprandial hyperglycemia[2].
• Improvements in Healthcare Infrastructure: Enhanced healthcare infrastructure, especially in developing countries, is increasing access to these medications[2].
• Launch of Generic Versions: The introduction of generic versions of repaglinide is expected to improve affordability and accessibility, further boosting market growth[2].

Market Trends

New Product Launches

The market is witnessing a surge in new product launches, including novel formulations and combinations of existing drugs. These launches are expected to flourish the market by offering more treatment options and improving patient outcomes[5].

Increased Diabetes Awareness

Diabetes awareness campaigns, funded by both private and government entities, are driving demand for early diagnosis and treatment. This increased awareness is a significant factor in the market's growth[5].

R&D Activities

Continuous research and development activities aimed at improving the quality and efficacy of diabetes drugs are also contributing to market expansion. Innovations in drug delivery systems and the development of new molecules are expected to shape the future of the market[5].

Challenges and Opportunities

Side Effects and Substitutes

Despite the growth potential, the market faces challenges such as side effects associated with the drugs and the availability of alternative treatments like homeopathy. However, these challenges are mitigated by the lifelong need for diabetes treatment drugs and growth opportunities in emerging markets[5].

Key Takeaways

• Effective Combination Therapy: Repaglinide and metformin hydrochloride combination therapy is effective for managing type 2 diabetes, especially in patients inadequately controlled with monotherapy.
• Safety Profile: The combination has a manageable safety profile, with common adverse reactions including hypoglycemia and gastrointestinal side effects.
• Market Growth: The market is expected to grow significantly, driven by the increasing prevalence of type 2 diabetes, improvements in healthcare infrastructure, and the launch of generic versions.
• New Product Launches: New product launches and increased diabetes awareness are key trends driving market growth.
• R&D Activities: Continuous R&D activities are crucial for improving drug efficacy and patient outcomes.

FAQs

Q: What is the recommended starting dose for repaglinide and metformin hydrochloride combination therapy?

A: The recommended starting dose is typically 1 mg repaglinide/500 mg metformin hydrochloride, administered twice daily with meals, with gradual dose escalation based on glycemic response[1][4].

Q: What are the common adverse reactions associated with repaglinide and metformin hydrochloride combination therapy?

A: Common adverse reactions include hypoglycemia, headache, and gastrointestinal reactions such as diarrhea, nausea, and vomiting[4].

Q: Is there an increased risk of lactic acidosis with metformin use?

A: No, extensive studies have shown that metformin does not increase the risk of lactic acidosis when used appropriately[3].

Q: What are the key drivers of the repaglinide market growth?

A: The key drivers include the increasing global prevalence of type 2 diabetes, improvements in healthcare infrastructure, and the launch of generic versions of repaglinide[2].

Q: What are the future trends expected in the repaglinide and metformin hydrochloride market?

A: Future trends include new product launches, increased diabetes awareness, and continuous R&D activities aimed at improving drug efficacy and patient outcomes[5].

Sources

1. Drugs.com: PrandiMet: Package Insert / Prescribing Information.
2. Market Research Intellect: Repaglinide Market Size, Trends and Projections.
3. JAMA Network: Risk of Fatal and Nonfatal Lactic Acidosis With Metformin Use in Type 2 Diabetes Mellitus.
4. Drugs.com: Repaglinide and Metformin Tablets: Package Insert / Prescribing Info.
5. Allied Market Research: Metformin Hydrochloride Market Size | Industry Growth By.