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.

Clinical Trial Conditions for REPAGLINIDE

Condition Name

Condition Name for REPAGLINIDE
Intervention	Trials
Diabetes Mellitus, Type 2	31
Diabetes	24
Healthy	7
Type 2 Diabetes Mellitus	4

Condition MeSH

Condition MeSH for REPAGLINIDE
Intervention	Trials
Diabetes Mellitus	39
Diabetes Mellitus, Type 2	37
Cystic Fibrosis	4
Fibrosis	4

Clinical Trial Locations for REPAGLINIDE

Trials by Country

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Trials by Country for REPAGLINIDE
Location	Trials
United States	65
China	26
South Africa	5
Italy	4
Canada	4

Trials by US State

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Trials by US State for REPAGLINIDE
Location	Trials
Florida	8
Texas	7
Arizona	3
Utah	3
Pennsylvania	3

Clinical Trial Progress for REPAGLINIDE

Clinical Trial Phase

Clinical Trial Phase for REPAGLINIDE
Clinical Trial Phase	Trials
Phase 4	22
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for REPAGLINIDE
Clinical Trial Phase	Trials
Completed	51
Recruiting	6
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	56
Other	40
NIH	3

Repaglinide: Clinical Trials, Market Analysis, and Projections

Introduction

Repaglinide, a carbamoylmethyl benzoic acid derivative, is a mealtime insulin secretagogue used in the treatment of type 2 diabetes. It works by stimulating insulin secretion from the pancreatic beta cells, thereby reducing postprandial glucose peaks and overall blood glucose levels. Here, we will delve into the clinical trials, market analysis, and projections for repaglinide.

Clinical Trials: Efficacy and Safety

Monotherapy Trials

A significant clinical trial compared the efficacy and safety of repaglinide versus nateglinide in patients with type 2 diabetes who had been treated with diet and exercise in the previous 3 months. This 16-week study involved 150 patients randomized to receive either repaglinide or nateglinide. The results showed that repaglinide monotherapy was more effective than nateglinide in reducing HbA1c and fasting plasma glucose (FPG) values. Repaglinide reduced HbA1c by 1.57% compared to 1.04% for nateglinide, and FPG by 57 mg/dl compared to 18 mg/dl for nateglinide[1].

Combination Therapy Trials

Another clinical trial evaluated the efficacy and safety of repaglinide versus nateglinide when used in combination with metformin. This 16-week study involved 192 patients who were randomized to receive either repaglinide or nateglinide in addition to metformin. The results indicated that the addition of repaglinide to metformin resulted in greater reductions in HbA1c and FPG compared to the addition of nateglinide. Repaglinide/metformin combination therapy reduced HbA1c by 1.28% compared to 0.67% for nateglinide/metformin[4].

Safety Profile

Both monotherapy and combination therapy trials highlighted that repaglinide is generally safe, although it may cause minor hypoglycemic episodes more frequently than nateglinide. In the monotherapy trial, 7% of patients treated with repaglinide experienced minor hypoglycemia, whereas no patients in the nateglinide group did[1]. Weight gain was also noted, with a mean weight gain of 1.8 kg in the repaglinide group compared to 0.7 kg in the nateglinide group[1].

Market Analysis

Current Market Status

The global repaglinide market has been growing steadily, driven by the increasing prevalence of type 2 diabetes and the need for effective glucose control. As of 2018, the market size was valued at a significant amount, and it is projected to expand at a certain CAGR from 2019 to 2025[5].

Market Competition

The repaglinide market is competitive, with various countries such as the USA, EU, Japan, and China playing significant roles. The market competition is analyzed based on production, consumption, and market share by country[5].

Market Forecast

The global and Chinese repaglinide market is expected to see continued growth from 2024 to 2029. This growth is anticipated in terms of capacity, production, and production value. The market forecast also includes an analysis of supply and consumption, as well as import and export trends[5].

Projections for 2025 and Beyond

Pharmaceutical Market Trends

In 2025, the pharmaceutical market is expected to see significant growth, particularly in the areas of obesity and oncology treatments. However, the incretin class, which includes GLP-1s, is projected to lead the market. While repaglinide is not a GLP-1, its efficacy in managing type 2 diabetes positions it as a relevant treatment option in a growing market[2].

Economic Impact

The macroeconomic environment, both globally and in China, will influence the repaglinide market. Factors such as economic growth, healthcare policies, and access to capital will impact the market dynamics. The report highlights the need for market entry strategies, countermeasures for economic impact, and feasibility studies for new project investments[5].

Key Takeaways

• Clinical Efficacy: Repaglinide has been shown to be more effective than nateglinide in reducing HbA1c and FPG levels in both monotherapy and combination therapy with metformin.
• Safety: Repaglinide is generally safe but may cause minor hypoglycemic episodes and weight gain.
• Market Growth: The global repaglinide market is projected to grow from 2019 to 2025, driven by increasing demand for effective diabetes treatments.
• Market Forecast: Continued growth is anticipated in the global and Chinese repaglinide market from 2024 to 2029.
• Economic Impact: The market will be influenced by macroeconomic factors, including economic growth and healthcare policies.

FAQs

Q1: What is repaglinide used for?

Repaglinide is used in the treatment of type 2 diabetes to reduce postprandial glucose peaks and overall blood glucose levels.

Q2: How does repaglinide compare to nateglinide in clinical trials?

Repaglinide has been shown to be more effective than nateglinide in reducing HbA1c and FPG levels in both monotherapy and combination therapy with metformin.

Q3: What are the common side effects of repaglinide?

Common side effects include minor hypoglycemic episodes and weight gain.

Q4: What is the projected market growth for repaglinide?

The global repaglinide market is projected to grow from 2019 to 2025, with continued growth anticipated from 2024 to 2029.

Q5: How does the macroeconomic environment impact the repaglinide market?

The macroeconomic environment, including economic growth and healthcare policies, will influence the market dynamics and growth of the repaglinide market.

Sources

1. Diabetes Care: Repaglinide Versus Nateglinide Monotherapy - A Clinical Trial.
2. Evaluate Pharma: 2025 Preview for Pharma Market.
3. ResearchGate: Repaglinide - A Pharmacoeconomic Review.
4. Diabetes Care: Efficacy and Safety of Combination Therapy.
5. Prof Research: Repaglinide Market Size, Share, Trend and Forecast to 2025.