CLINICAL TRIALS PROFILE FOR PRANDIN

All Clinical Trials for PRANDIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	National Institutes of Health (NIH)	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	Novo Nordisk A/S	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
NCT00763412 ↗	Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis	Completed	Washington University School of Medicine	N/A	2006-11-01	The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.

Clinical Trial Conditions for PRANDIN

Condition Name

Condition Name for PRANDIN
Intervention	Trials
Cystic Fibrosis Related Diabetes	1
Diabetes Mellitus, Type 2	1
Pancreatic Insufficiency	1
Sickle Cell Disease	1

Condition MeSH

Condition MeSH for PRANDIN
Intervention	Trials
Diabetes Mellitus	2
Cystic Fibrosis	1
Diabetes Mellitus, Type 2	1
Prediabetic State	1

Clinical Trial Locations for PRANDIN

Trials by Country

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Trials by Country for PRANDIN
Location	Trials
United Kingdom	2
United States	2

Trials by US State

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−

Trials by US State for PRANDIN
Location	Trials
Texas	1
Missouri	1

Clinical Trial Progress for PRANDIN

Clinical Trial Phase

Clinical Trial Phase for PRANDIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for PRANDIN
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for PRANDIN

Sponsor Name

Sponsor Name for PRANDIN
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1
National Institutes of Health (NIH)	1
Novo Nordisk A/S	1

Sponsor Type

Sponsor Type for PRANDIN
Sponsor	Trials
Other	4
NIH	2
Industry	2

Clinical Trials, Market Analysis, and Projections for PRANDIN (Repaglinide)

Introduction

PRANDIN, also known as repaglinide, is a medication used to manage type 2 diabetes by stimulating the release of insulin from the pancreas. Here, we will delve into the clinical trials, adverse reactions, market analysis, and future projections for this drug.

Clinical Trials Experience

PRANDIN has been extensively tested in various clinical trials involving a significant number of participants. Here are some key points from these trials:

• Participant Numbers: PRANDIN was administered to 2931 individuals during clinical trials. Of these, approximately 1500 individuals with type 2 diabetes were treated for at least 3 months, 1000 for at least 6 months, and 800 for at least 1 year[1][3].
• Adverse Reactions: The most common adverse reactions leading to withdrawal from the trials were hyperglycemia, hypoglycemia, and related symptoms. Over one year, 13% of PRANDIN patients were discontinued due to adverse reactions[1][3].
• Common Adverse Reactions: Table 1 from the clinical trials data shows that common adverse reactions (occurring in ≥ 2% of patients) included upper respiratory infection, headache, sinusitis, arthralgia, nausea, diarrhea, back pain, and others[1][3].

Hypoglycemia in Clinical Trials

Hypoglycemia is a significant concern with PRANDIN:

• Incidence: Hypoglycemia was the most commonly observed adverse reaction, occurring in 31% of PRANDIN-treated patients compared to 7% of placebo-treated patients. In 1-year controlled trials, hypoglycemia was reported in 16% of PRANDIN patients, 20% of glyburide patients, and 19% of glipizide patients[1][3].
• Severity: None of the PRANDIN-treated patients with symptomatic hypoglycemia developed coma or required hospitalization[1].

Cardiovascular Events

The incidence of cardiovascular events in PRANDIN trials is noteworthy:

• Comparison to Sulfonylureas: The incidence of total serious cardiovascular adverse events was higher for PRANDIN (4%) compared to sulfonylurea drugs (3%) in controlled comparator clinical trials. Cardiac ischemic events and deaths due to cardiovascular events were also slightly higher in the PRANDIN group[1][3].

Combination Therapy

PRANDIN has been studied in combination with other therapies:

• Thiazolidinediones: Combination therapy with rosiglitazone or pioglitazone showed similar rates of hypoglycemia compared to PRANDIN monotherapy. However, significant weight gain was observed in these combination therapies[1].
• Insulin and Other Combinations: PRANDIN combination therapy with NPH-insulin or other combinations also showed adverse events, including myocardial ischemia in some patients[1][3].

Market Analysis

While PRANDIN is not a blockbuster drug in the same league as some newer diabetes medications, it still holds a place in the market:

• Current Market: PRANDIN is part of the broader diabetes market, which is dominated by newer classes of drugs such as GLP-1 receptor agonists (GLP1RAs) and SGLT2 inhibitors. These newer drugs have shown significant therapeutic advances and safety profiles, potentially impacting the market share of older drugs like PRANDIN[4].
• Competitive Landscape: The diabetes market is highly competitive, with many drugs available for managing type 2 diabetes. PRANDIN's market share is likely to be affected by the increasing popularity of newer, more effective treatments.

Future Projections

Given the current trends and the emergence of new therapies, here are some projections for PRANDIN:

• Declining Market Share: As newer and more effective diabetes medications gain traction, PRANDIN's market share is likely to decline. The robust findings from clinical trials of GLP1RAs and other newer agents will continue to shift the treatment paradigm away from older drugs like PRANDIN[4].
• Niche Use: PRANDIN may still find use in specific patient populations where it is preferred due to its rapid onset and short duration of action. However, this niche use will likely be limited compared to the broader adoption of newer therapies.
• Generic Competition: As patents expire, generic versions of PRANDIN could become more prevalent, further reducing its market share and revenue.

Key Takeaways

• Clinical Trials: PRANDIN has been tested in extensive clinical trials, highlighting its efficacy and common adverse reactions.
• Hypoglycemia: Hypoglycemia is a significant concern with PRANDIN, occurring more frequently than in placebo groups.
• Cardiovascular Events: PRANDIN shows a slightly higher incidence of cardiovascular events compared to some other diabetes medications.
• Market Analysis: The market for PRANDIN is likely to decline as newer, more effective diabetes treatments become more popular.
• Future Projections: PRANDIN may find niche use but will face significant competition from newer therapies.

FAQs

What is PRANDIN used for?

PRANDIN (repaglinide) is used to manage type 2 diabetes by stimulating the release of insulin from the pancreas.

What are the common adverse reactions associated with PRANDIN?

Common adverse reactions include upper respiratory infection, headache, sinusitis, arthralgia, nausea, diarrhea, and back pain.

How common is hypoglycemia with PRANDIN?

Hypoglycemia is the most commonly observed adverse reaction, occurring in 31% of PRANDIN-treated patients compared to 7% of placebo-treated patients.

Does PRANDIN increase the risk of cardiovascular events?

Yes, PRANDIN shows a slightly higher incidence of total serious cardiovascular adverse events compared to some sulfonylurea drugs.

What is the future outlook for PRANDIN in the diabetes market?

PRANDIN's market share is likely to decline as newer, more effective diabetes treatments gain popularity and become more widely adopted.

Sources

1. RxList: Prandin (Repaglinide): Side Effects, Uses, Dosage, Interactions ...
2. GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
3. FDA: PRANDIN® (repaglinide) tablets, for oral use
4. ACC: GLP1RAs in Clinical Practice: Therapeutic Advances and Safety ...