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Sulfonamides, Urea Derivatives

This article discusses the ongoing clinical trials investigating the use of Sulfonamides, Urea Derivatives in patients with Type 2 Diabetes and increased cardiovascular risk. These trials aim to evaluate the effectiveness and safety of this drug class compared to standard treatments like insulin glargine. The research focuses on individuals who are overweight or obese and have additional health concerns such as cardiovascular diseases or chronic kidney disease.

Table of Contents

What are Sulfonamides, Urea Derivatives?

Sulfonamides, urea derivatives are a class of medications used primarily in the treatment of Type 2 Diabetes. These drugs belong to a group of medicines known as oral antidiabetics, which help control blood sugar levels in people with diabetes.[1]

Medical Conditions Treated

Based on the clinical trial information, sulfonamides, urea derivatives are being studied for their effectiveness in treating patients with:

  • Type 2 Diabetes: A condition where the body doesn’t use insulin properly, leading to high blood sugar levels.
  • Obesity or Overweight: Excess body weight that can increase health risks.
  • Cardiovascular Diseases: Conditions affecting the heart and blood vessels.
  • Chronic Kidney Disease: Long-term kidney damage that can worsen over time.

This medication is particularly being studied in patients who have Type 2 Diabetes along with obesity or overweight and are at high risk for cardiovascular problems.[1]

How It Works

Sulfonamides, urea derivatives work by helping the body produce more insulin and use it more effectively. Insulin is a hormone that helps move sugar from the blood into the cells, where it’s used for energy. By improving insulin function, these medications help lower blood sugar levels in people with Type 2 Diabetes.[1]

Dosage and Administration

According to the clinical trial data, the medication is taken orally (by mouth). The maximum daily dose being studied is 20 mg per day. The total maximum dose over the course of treatment is 6160 mg, which suggests the treatment period could last up to about 308 days (just over 10 months).[1]

It’s important to note that these dosages are specific to the clinical trial and may not reflect the final recommended dosages if the drug is approved for general use. Always follow your doctor’s instructions regarding medication dosage.

Who Can Take This Medication?

Based on the clinical trial eligibility criteria, this medication may be suitable for adults who:

  • Have Type 2 Diabetes
  • Have been taking 1 to 3 diabetes medications by mouth consistently for at least 3 months
  • Have heart disease
  • Have high blood sugar levels (HbA1c of at least 7.0%)

However, the medication may not be suitable for people who:

  • Have Type 1 Diabetes
  • Have a history of liver inflammation (hepatitis)
  • Have used any weight loss drugs, including herbal or nutritional supplements, in the last 3 months
  • Have a history of pancreatitis (inflammation of the pancreas)

It’s crucial to discuss your medical history and current medications with your doctor to determine if this medication is appropriate for you.[1]

Ongoing Clinical Study

A Phase 3 clinical trial (study number: J2A-MC-GZGS) is currently being conducted to evaluate the effectiveness and safety of this medication. The study is comparing a daily oral dose of a drug called Orforglipron (LY3502970) with insulin glargine in patients with Type 2 Diabetes who are overweight or obese and at increased cardiovascular risk.

The main objective of this study is to show that LY3502970 is not inferior to insulin glargine in preventing major adverse cardiovascular events (MACE-4). These events include:

  • Heart attack (Myocardial Infarction)
  • Stroke
  • Hospitalization for unstable angina (chest pain)
  • Death from cardiovascular causes

This study aims to provide important information about the safety and effectiveness of this new treatment option for people with Type 2 Diabetes who are at high risk for heart problems.[1]

Potential Side Effects

While specific side effects are not mentioned in the provided clinical trial data, it’s important to be aware that all medications can have potential side effects. Common side effects of diabetes medications may include nausea, diarrhea, or low blood sugar (hypoglycemia). However, the exact side effect profile of this particular medication would need to be determined through the clinical trial process.

Always report any unusual symptoms or side effects to your healthcare provider. They can help determine if these effects are related to the medication and advise on the best course of action.[1]

Aspect Details
Study Type Phase 3, Open-Label Study
Drug Tested LY3502970 (Sulfonamides, Urea Derivatives)
Comparison Insulin Glargine
Target Population Adults with Type 2 Diabetes, Obesity or Overweight, at Increased Cardiovascular Risk
Primary Objective Demonstrate non-inferiority in occurrence of MACE-4 events
Key Inclusion Criteria Type 2 Diabetes, on 1-3 oral diabetes drugs, heart disease, HbA1c ≥ 7.0%
Key Exclusion Criteria Type 1 diabetes, hepatitis history, recent weight loss drug use, pancreatitis history
Maximum Daily Dose 20 mg
Treatment Duration Up to 1 year

FAQ

  • What is the main purpose of the clinical trial using Sulfonamides, Urea Derivatives? The main purpose is to show that LY3502970 (a Sulfonamides, Urea Derivative) is not worse than insulin glargine in preventing major cardiovascular events in people with Type 2 Diabetes who are overweight or obese and at high cardiovascular risk.
  • Who can participate in this clinical trial? Participants must have Type 2 Diabetes, be taking 1 to 3 diabetes medications by mouth for at least 3 months, have heart disease, and have high blood sugar (HbA1c of at least 7.0%). They should also be overweight or obese and at increased cardiovascular risk.
  • What are some reasons why someone cannot participate in this trial? People cannot participate if they have type 1 diabetes, a history of liver inflammation (hepatitis), have used any weight loss drugs or supplements in the last 3 months, or have a history of pancreatitis.
  • What is the maximum daily dose of the Sulfonamides, Urea Derivatives being tested? The maximum daily dose of the Sulfonamides, Urea Derivatives being tested is 20 mg.
  • How long is the treatment period in this clinical trial? The maximum treatment period for this clinical trial is 1 year.

Ongoing Clinical Trials on Sulfonamides, Urea Derivatives

  • Evaluating Once Daily Orforglipron (LY3502970) Compared to Insulin Glargine in Adults with Type 2 Diabetes and Obesity or Overweight who Have Increased Cardiovascular Risk

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Germany Greece Italy Romania +2

Glossary

  • Type 2 Diabetes: A chronic condition that affects the way your body processes blood sugar (glucose). It's characterized by high blood sugar levels due to insulin resistance or insufficient insulin production.
  • Cardiovascular Disease: A group of disorders of the heart and blood vessels, including conditions like heart disease and stroke.
  • Chronic Kidney Disease: A condition characterized by gradual loss of kidney function over time.
  • Hemoglobin A1C (HbA1c): A blood test that measures your average blood sugar levels over the past 2-3 months. It's used to diagnose and monitor diabetes.
  • Insulin Glargine: A long-acting type of insulin used to control blood sugar levels in people with diabetes.
  • MACE-4: Major Adverse Cardiovascular Events, including heart attack, stroke, hospitalization for unstable angina, or death from cardiovascular causes.
  • Pancreatitis: Inflammation of the pancreas, which can be acute or chronic.
  • Sulfonamides, Urea Derivatives: A class of drugs used to treat diabetes by helping to control blood sugar levels.
  • LY3502970: An investigational drug belonging to the Sulfonamides, Urea Derivatives class, being studied for the treatment of Type 2 Diabetes.

References

  1. http://clinicaltrials.eu/trial/study-comparing-ly3502970-with-insulin-glargine-for-adults-with-type-2-diabetes-obesity-or-overweight-at-high-cardiovascular-risk/