CLINICAL TRIALS PROFILE FOR PROGLYCEM

All Clinical Trials for Proglycem

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00892073 ↗	Hypothalamic Obesity Following Craniopharyngioma Surgery: A Pilot Trial of Combined Metformin and Diazoxide Therapy	Completed	The Hospital for Sick Children	Phase 2	2006-05-01	To study the effect of combined diazoxide-metformin therapy on body weight in youth with hypothalamic obesity following treatment for craniopharyngioma. A secondary objective is to evaluate changes in insulin resistance (IR), beta-cell function, features of the metabolic syndrome, muscle metabolism and intramyocellular lipid. Hypothesis: Treatment with diazoxide and metformin will result in weight loss or slowed weight gain and improved metabolic profile, compared to pretreatment levels.
NCT00987168 ↗	Sandostatine® LP and Hyperinsulinism	Completed	Novartis	Phase 2	2009-05-01	To replace Sandostatine® in three daily subcutaneous injections by a single intramuscular injection of Sandostatine® LP per month in patients with a diffuse form of hyperinsulinism.
NCT00987168 ↗	Sandostatine® LP and Hyperinsulinism	Completed	Assistance Publique - Hôpitaux de Paris	Phase 2	2009-05-01	To replace Sandostatine® in three daily subcutaneous injections by a single intramuscular injection of Sandostatine® LP per month in patients with a diffuse form of hyperinsulinism.
NCT03540758 ↗	Regulation of Endogenous Glucose Production by Central KATP Channels	Recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2018-08-01	Type 2 diabetes affects the ability of the body to process glucose (sugar). Under fasting conditions, the liver is able to make sugar to maintain glucose levels in an important process called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to regulate levels of glucose in the body by communicating with the liver. This process can be impaired in people with type 2 diabetes, and can contribute to the high level of glucose seen in these individuals. The purpose of this study is to understand how activating control centers of the brain with a medication called diazoxide can affect how much glucose (sugar) is made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn can lead to diabetes complications.
NCT03540758 ↗	Regulation of Endogenous Glucose Production by Central KATP Channels	Recruiting	National Institutes of Health (NIH)	Phase 2	2018-08-01	Type 2 diabetes affects the ability of the body to process glucose (sugar). Under fasting conditions, the liver is able to make sugar to maintain glucose levels in an important process called endogenous glucose production (EGP). Previous studies suggest that the central nervous system (CNS), including the brain, helps to regulate levels of glucose in the body by communicating with the liver. This process can be impaired in people with type 2 diabetes, and can contribute to the high level of glucose seen in these individuals. The purpose of this study is to understand how activating control centers of the brain with a medication called diazoxide can affect how much glucose (sugar) is made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn can lead to diabetes complications.

Clinical Trial Conditions for Proglycem

Condition Name

Condition Name for Proglycem
Intervention	Trials
Glucose, High Blood	3
Diabetes Mellitus, Type 2	2
Glucose Metabolism Disorders	2
Type 2 Diabetes Mellitus	1

Condition MeSH

Condition MeSH for Proglycem
Intervention	Trials
Metabolic Diseases	3
Hyperglycemia	3
Glucose Metabolism Disorders	3
Diabetes Mellitus, Type 2	3

Clinical Trial Locations for Proglycem

Trials by Country

Trials by Country for Proglycem
Location	Trials
United States	4
France	1
Canada	1

Trials by US State

Trials by US State for Proglycem
Location	Trials
New York	4

Clinical Trial Progress for Proglycem

Clinical Trial Phase

Clinical Trial Phase for Proglycem
Clinical Trial Phase	Trials
Phase 2	5
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Proglycem
Clinical Trial Phase	Trials
Completed	2
Recruiting	2
Suspended	2

Clinical Trial Sponsors for Proglycem

Sponsor Name

Sponsor Name for Proglycem
Sponsor	Trials
Albert Einstein College of Medicine	3
Albert Einstein College of Medicine, Inc.	3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2

Sponsor Type

Sponsor Type for Proglycem
Sponsor	Trials
Other	9
NIH	4
Industry	1

Clinical Trials, Market Analysis, and Projections for Proglycem (Diazoxide)

Introduction to Proglycem (Diazoxide)

Proglycem, also known as diazoxide, is a prescription medication approved by the FDA for the management of hypoglycemia caused by hyperinsulinism. This condition is characterized by an excessive production of insulin, leading to abnormally low blood sugar levels. Here, we will delve into the current clinical trials, market analysis, and future projections for Proglycem.

Clinical Trials and Emerging Therapies

Current Use and Clinical Trials

Proglycem is the primary approved therapy for managing symptomatic hypoglycemia in patients with congenital hyperinsulinism (CHI) and other conditions involving excessive insulin production. However, there are ongoing efforts to develop new treatments and improve existing ones.

• HM15136 Trial: In October 2021, Hanmi Pharm.Co., Ltd. initiated a Phase 2 clinical trial for HM15136, a glucagon analog, to evaluate its safety, tolerability, pharmacokinetics, and efficacy as an add-on therapy in subjects with CHI who experience persistent hypoglycemia. This trial is expected to be completed by March 2025[2].

• Other Emerging Therapies: Several other drugs are in various stages of development, including dasiglucagon by Zealand Pharma, XOMA 358/RZ358 by XOMA/Rezolute, CSI-Glucagon (Continuous Subcutaneous Glucagon Infusion) by Xeris Pharmaceuticals, and avexitide by Eiger BioPharmaceuticals. These therapies aim to provide alternative or complementary treatments for CHI patients[5].

Market Analysis

Market Size and Growth

The congenital hyperinsulinism treatment market, which Proglycem is a part of, is experiencing significant growth. As of 2022, the global market size for CHI treatments was estimated at US$ 206.0 million. This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.7% from 2022 to 2030, reaching an estimated value of US$ 319.9 million by 2030[2].

Key Drivers

Several factors are driving the growth of the CHI treatment market:

• Increasing Awareness: Growing awareness of congenital hyperinsulinism among the population, facilitated by organizations like Congenital Hyperinsulinism International, is a significant driver. These organizations provide support, raise awareness, and facilitate conferences to share patient experiences and discuss treatment aspects[2].

• Research and Development: Active research and development activities, including the clinical trials mentioned above, are expected to drive market growth. Pharmaceutical companies such as Zealand Pharma, Eli Lilly and Company, and Hanmi Pharm.Co., Ltd. are investing in new therapies and treatments[2].

Market Share and Distribution

The market share of CHI treatments varies by region and distribution channel. In 2022, the global CHI treatment market share was analyzed by distribution channels, with a significant portion attributed to hospital and retail pharmacy sales. The market is also segmented by region, with North America, Europe, and Asia-Pacific being key markets[2].

Safety and Efficacy

Safety Review

Health Canada conducted a safety review of Proglycem due to potential risks of necrotizing enterocolitis in newborns and infants. The review found a possible link between the use of Proglycem and this condition, particularly in infants 2 months of age or younger. As a result, Health Canada is updating the product monograph to include this risk and informing healthcare professionals about the update[3].

Efficacy and Side Effects

Proglycem is effective in managing hypoglycemia by inhibiting the release of insulin from the pancreas. However, it can cause several side effects, including hyperglycemia, hirsutism, gastrointestinal intolerance, tachycardia, and increased levels of serum uric acid. The drug is contraindicated for functional hypoglycemia and in patients hypersensitive to diazoxide or other thiazides[1][4].

Dosage and Administration

The dosage of Proglycem must be individualized based on the severity of the hypoglycemic condition and the patient's blood glucose level and clinical response. The usual daily dosage is 3 to 8 mg/kg, divided into two or three equal doses every 8 or 12 hours. Special care is required to ensure accurate dosing in infants and young children[1].

Market Projections

Future Outlook

The CHI treatment market is expected to continue growing due to increasing awareness, ongoing research, and the development of new therapies. The projected CAGR of 5.7% indicates a steady and significant growth trajectory over the next several years.

• Emerging Therapies: The introduction of new treatments, such as HM15136 and other glucagon analogs, is expected to expand the treatment options for CHI patients, potentially capturing a larger market share[2].

• Market Expansion: The market is likely to expand into new regions and distribution channels, further increasing its reach and revenue[2].

Key Takeaways

• Proglycem (diazoxide) is the primary approved therapy for managing symptomatic hypoglycemia in CHI and other hyperinsulinism conditions.
• Clinical Trials: Ongoing trials, such as the HM15136 trial, are exploring new treatments to complement or replace Proglycem.
• Market Growth: The CHI treatment market is growing at a CAGR of 5.7%, driven by increasing awareness and research activities.
• Safety Concerns: Proglycem has been associated with potential risks such as necrotizing enterocolitis in newborns and infants.
• Efficacy and Side Effects: Proglycem is effective but can cause various side effects, necessitating careful monitoring and dosage adjustment.

FAQs

What is Proglycem used for?

Proglycem (diazoxide) is used to treat hypoglycemia caused by hyperinsulinism, which can be associated with conditions such as islet cell adenoma or carcinoma, leucine sensitivity, and congenital hyperinsulinism[1][4].

What are the common side effects of Proglycem?

Common side effects include hyperglycemia, hirsutism, gastrointestinal intolerance, tachycardia, and increased levels of serum uric acid. It can also cause fluid retention and, in some cases, necrotizing enterocolitis in newborns and infants[1][3].

What is the dosage of Proglycem?

The usual daily dosage is 3 to 8 mg/kg, divided into two or three equal doses every 8 or 12 hours. The dosage must be individualized based on the patient's condition and response[1].

Are there any emerging therapies for CHI?

Yes, several emerging therapies are in development, including HM15136, dasiglucagon, XOMA 358/RZ358, CSI-Glucagon, and avexitide. These therapies aim to provide alternative or complementary treatments for CHI patients[2][5].

What is the projected market size for CHI treatments by 2030?

The global CHI treatment market is projected to reach US$ 319.9 million by 2030, growing at a CAGR of 5.7% from 2022 to 2030[2].

Sources

1. PROGLYCEM® brand of diazoxide Capsules - FDA Label[1]
2. Congenital Hyperinsulinism Treatment Market Size & Share Analysis - Coherent Market Insights[2]
3. Summary Safety Review – Proglycem (diazoxide) - Health Canada[3]
4. Proglycem: Dosage, side effects, uses, and more - Medical News Today[4]
5. Congenital Hyperinsulinism Market Insights, Epidemiology and Market Forecast - 2030 - ResearchAndMarkets.com[5]