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L-PROLINE

Recent clinical research has examined the use of Ipragliflozin L-proline in the treatment of Type 2 Diabetes Mellitus. This drug, also known by the brand name Suglat, has been studied as an additional treatment option for patients who don’t achieve adequate blood sugar control with metformin alone. The clinical trial focused on measuring how effectively the combination of Ipragliflozin L-proline and metformin could reduce blood sugar levels compared to metformin plus placebo, while also monitoring safety outcomes and quality of life improvements in patients. This article explores the key findings and implications of this important research for diabetes management.

Table of Contents

What is L-Proline?

L-Proline is a component used in the medication being studied in this clinical trial. The specific medication is called Ipragliflozin L-proline, which is also known by its brand name Suglat or by its research code ASP1941[1]. L-proline is an amino acid that in this case is part of the formulation of ipragliflozin, which belongs to a class of medications called SGLT2 inhibitors (sodium-glucose co-transporter-2 inhibitors).

Ipragliflozin L-Proline for Type 2 Diabetes

Ipragliflozin L-proline is being studied as a treatment for Type 2 Diabetes Mellitus, specifically for patients who have inadequate blood sugar control despite taking metformin[1]. Metformin (available under brand names like Glucophage, Riomet, Glumetza, Fortamet, and Glucophage XR) is typically the first medication prescribed for type 2 diabetes, but sometimes it’s not enough to control blood sugar levels on its own.

The clinical trial is examining whether adding ipragliflozin L-proline to metformin therapy provides better blood sugar control than metformin alone[1].

Clinical Trial Information

The study being conducted is a Phase 3, double-blind, randomized study[1]. Let’s break down what this means:

  • Phase 3: This means the drug has already passed initial safety testing and is being tested in a larger group of people to confirm its effectiveness, monitor side effects, and compare it to commonly used treatments.
  • Double-blind: Neither the participants nor the researchers know who is receiving which treatment, which helps prevent bias in the results.
  • Randomized: Participants are randomly assigned to different treatment groups, which helps ensure the groups are comparable.

The study is being conducted in Russia and involves patients with type 2 diabetes who are already taking metformin but not achieving adequate blood sugar control[1].

The study process includes:

  1. A 10-day (±3 days) screening period
  2. A 2-week single-blind placebo run-in period
  3. A 24-week randomized double-blind treatment period
  4. A 4-week follow-up period

Treatment Combinations Being Studied

The study is comparing three different treatment approaches[1]:

  1. Metformin and placebo: Participants receive their daily metformin plus a placebo tablet (a tablet with no active medication).
  2. Metformin and Ipragliflozin: Participants receive their daily metformin plus ipragliflozin L-proline (in two different dose strengths).
  3. Metformin, placebo and Ipragliflozin: Participants receive their daily metformin, a placebo, and ipragliflozin L-proline (in one dose strength).

All medications in the study are taken orally (by mouth) as tablets[1].

What Outcomes Are Being Measured?

The study is measuring several important outcomes to determine if ipragliflozin L-proline is effective and safe[1]:

Primary Outcome:

  • Change in HbA1c: The main measure is the change in glycated hemoglobin (HbA1c) from baseline to 12 weeks. HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months and is the standard way to monitor diabetes control.

Secondary Outcomes:

  • Long-term HbA1c change: Change in HbA1c from baseline to 24 weeks
  • Fasting plasma glucose (FPG) changes: This measures blood sugar levels after an overnight fast
  • Treatment targets: The number and percentage of patients reaching the treatment goal of HbA1c less than 7.0%
  • Body weight changes: Whether the treatment affects body weight
  • Blood pressure changes: Effects on blood pressure
  • Safety measures: Number and percentage of patients experiencing adverse events (side effects)
  • Quality of life measures: Changes in patient-reported outcomes using several questionnaires that assess quality of life, satisfaction with diabetes medication, and impact on work productivity

Potential Benefits for Patients

Based on the study design, ipragliflozin L-proline may offer several potential benefits for patients with type 2 diabetes[1]:

  • Improved blood sugar control: The primary goal is better management of blood glucose levels, especially for patients who aren’t achieving good control with metformin alone
  • Potential weight loss: The study is measuring changes in body weight, suggesting that ipragliflozin may help with weight management, which is often beneficial for people with type 2 diabetes
  • Possible blood pressure reduction: Since the study is tracking blood pressure changes, there may be cardiovascular benefits
  • Enhanced quality of life: The inclusion of multiple quality of life questionnaires indicates a focus on how the treatment affects patients’ overall wellbeing and satisfaction with their diabetes management

Possible Side Effects

The study is specifically monitoring for several categories of side effects[1]:

  • Hypoglycemic events: Low blood sugar episodes, which can cause symptoms like shakiness, sweating, confusion, and in severe cases, loss of consciousness
  • Dehydration/hypovolemia: Reduced body fluid volume, which can cause dizziness, lightheadedness, and weakness
  • Urinary tract infections: Infections affecting the urinary system, which can cause painful urination, frequent urination, and cloudy urine
  • Genital infections: Infections affecting the genital area, which are more common with SGLT2 inhibitors like ipragliflozin

These “adverse events of special interest” are being closely monitored because they are known potential side effects of SGLT2 inhibitor medications, the class to which ipragliflozin belongs[1].

Impact on Quality of Life

The study places significant emphasis on how the treatment affects patients’ quality of life, using four different questionnaires[1]:

  • European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L): A standardized instrument for measuring general health status
  • Audit of Diabetes Dependent Quality of Life (ADDQoL-19): This specifically measures how diabetes impacts various aspects of life
  • Work Productivity and Activity Impairment: General Health (WPAI:GH): This assesses how health problems affect ability to work and perform regular activities
  • Diabetes Medication Satisfaction (Diab-MedSat): This measures satisfaction with diabetes medications

These measurements help determine not just whether the medication improves clinical outcomes, but also whether it makes patients feel better about their diabetes management and overall health[1].

Aspect Details
Drug Studied Ipragliflozin L-proline (also known as Suglat or ASP1941)
Condition Targeted Type 2 Diabetes Mellitus with inadequate glycemic control on metformin
Study Design Phase 3, double-blind, randomized study conducted in Russia
Study Duration 10-day screening, 2-week placebo run-in, 24-week treatment, 4-week follow-up
Treatment Groups 1. Metformin and placebo
2. Metformin and Ipragliflozin (2 dose strengths)
3. Metformin, placebo and Ipragliflozin (1 dose strength)
Primary Outcome Change from baseline in HbA1c at 12 weeks
Key Secondary Outcomes – Change in HbA1c at 24 weeks
– Change in fasting plasma glucose
– Percentage of patients reaching HbA1c < 7.0%
– Changes in body weight and blood pressure
– Safety assessments
– Quality of life measurements
Safety Focus Areas Hypoglycemic events, dehydration/hypovolemia, urinary tract infections, genital infections
Quality of Life Assessments EQ-5D-5L, ADDQoL-19, WPAI:GH, and Diab-MedSat questionnaires

FAQ

  • What is Ipragliflozin L-proline and how does it work for diabetes? Ipragliflozin L-proline (also known by the brand name Suglat) is a medication being studied for Type 2 Diabetes Mellitus. It belongs to a class of drugs that work by helping the kidneys remove excess sugar from the bloodstream, which is then eliminated through urine. In the clinical trial, it was tested as an add-on therapy for patients who weren't achieving good blood sugar control with metformin alone.
  • What was the main purpose of the clinical trial studying L-proline? The main purpose of the trial was to evaluate how effectively Ipragliflozin L-proline, when combined with metformin, could reduce glycated hemoglobin (HbA1c) levels compared to metformin plus placebo. HbA1c is an important measurement of long-term blood sugar control. The study specifically targeted patients with Type 2 Diabetes Mellitus who weren't achieving adequate blood sugar control with metformin alone.
  • How long did the clinical trial for Ipragliflozin L-proline last? The complete clinical trial structure consisted of a 10-day (±3 days) screening period, followed by a 2-week single-blind placebo run-in period, then a 24-week randomized double-blind treatment period, and finally a 4-week follow-up period. The primary measurements were taken at baseline and at 12 weeks, with additional measurements at 24 weeks.
  • Besides blood sugar control, what other effects of Ipragliflozin L-proline were studied? In addition to blood sugar control (measured by HbA1c and fasting plasma glucose), the study examined several other important factors: changes in body weight, blood pressure, quality of life measurements through various questionnaires (EQ-5D-5L, ADDQoL-19, WPAI:GH, and Diab-MedSat), and safety outcomes including adverse events. The researchers were particularly interested in specific side effects like hypoglycemia (low blood sugar), dehydration, and urinary tract or genital infections.
  • How was the clinical trial structured to ensure reliable results? The trial was designed as a Phase 3, double-blind, randomized study. This means it was in an advanced testing phase, neither the participants nor the researchers knew who was receiving the actual medication versus placebo (double-blind), and patients were randomly assigned to different treatment groups. The study included multiple treatment arms: one group received metformin and placebo, another received metformin and Ipragliflozin L-proline at two different dose strengths, and a third received metformin, placebo, and Ipragliflozin L-proline at one dose strength. This rigorous design helps ensure that the results are reliable and not influenced by bias.

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Glossary

  • Type 2 Diabetes Mellitus: A chronic condition that affects the way your body processes blood sugar (glucose). In Type 2 diabetes, either your body doesn't produce enough insulin or it resists insulin's effects, causing glucose to build up in your bloodstream instead of moving into cells to be used for energy.
  • Ipragliflozin L-proline: A medication being studied for Type 2 Diabetes Mellitus, also known by the brand name Suglat or ASP1941. It belongs to a class of drugs called SGLT2 inhibitors that work by helping the kidneys filter out more glucose from the bloodstream into the urine.
  • Metformin: A first-line medication for treating Type 2 Diabetes. It works by reducing glucose production in the liver and improving insulin sensitivity in the body, allowing cells to more effectively remove sugar from the blood. Brand names include Glucophage, Glumetza, and Riomet.
  • Glycated hemoglobin (HbA1c): A blood test that measures your average blood sugar levels over the past 2-3 months. It shows the percentage of hemoglobin proteins in your blood that are coated with sugar. Higher levels indicate poorer blood sugar control and greater risk of diabetes complications.
  • Fasting Plasma Glucose (FPG): A blood test that measures your blood sugar level after an overnight fast (not eating). It's used to diagnose diabetes and monitor glucose control in people with diabetes.
  • Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs. In clinical trials, some patients receive the medication being tested while others receive a placebo to determine if the drug's effects are due to the drug itself or psychological factors.
  • Double-blind study: A research study in which neither the participants nor the researchers know who is receiving which treatment. This helps prevent bias in reporting and evaluating results.
  • Randomized study: A type of clinical trial in which participants are assigned by chance (randomly) to different treatment groups. This helps ensure that the groups are similar at the start of the study.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure. In clinical trials, all adverse events are carefully monitored and documented.
  • Hypoglycemia: A condition characterized by abnormally low blood glucose (blood sugar) levels, typically below 70 mg/dL. Symptoms may include shakiness, dizziness, sweating, hunger, irritability, and confusion.
  • Phase 3 trial: A stage in clinical research that tests the effectiveness and safety of a new treatment using a large group of people. These trials happen after earlier phases have established basic safety and dosing information.
  • Patient-reported outcomes (PROs): Information about a patient's health condition that comes directly from the patient, without interpretation by healthcare providers or anyone else. In this study, several questionnaires were used to gather patient perspectives.
  • EQ-5D-5L questionnaire: A standardized instrument used to measure health-related quality of life. It assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity.
  • ADDQoL-19 questionnaire: Audit of Diabetes Dependent Quality of Life questionnaire, which measures how diabetes affects an individual's quality of life across 19 different domains.

References

  1. https://clinicaltrials.gov/study/NCT02794792