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Study on the Safety and Effectiveness of Metformin Hydrochloride, Dapagliflozin, and Canagliflozin in Elderly Patients with Type 2 Diabetes

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of certain medications on Type 2 diabetes mellitus in elderly patients. The medications being tested are known as SGLT-2 inhibitors, which help lower blood sugar levels. The specific drugs involved in this study include Xigduo, Vokanamet, Forxiga, Synjardy, Jardiance, and Invokana. These medications contain active substances such as metformin hydrochloride, dapagliflozin, canagliflozin, and empagliflozin. Some of these substances, like canagliflozin, may also be referred to by code names such as JNJ-28431754.

The purpose of the study is to compare how well these medications help patients reach their personalized blood sugar goals without experiencing severe low blood sugar episodes, known as level-3 hypoglycemia. The trial will last for up to 36 months, during which participants will take the medications orally in the form of film-coated tablets. The study will monitor various health aspects, including changes in blood sugar levels, body weight, blood pressure, and kidney function. It will also assess the safety of the medications by tracking any hospitalizations, severe hypoglycemia, infections, dehydration, bone fractures, amputations, or diabetic ketoacidosis, which is a serious diabetes complication.

Participants in the study will be elderly individuals with Type 2 diabetes, and the trial aims to provide valuable insights into the effectiveness and safety of SGLT-2 inhibitors in managing this condition. The study will help determine which medication is most effective in helping patients achieve their blood sugar targets while minimizing the risk of severe side effects. The trial is designed to be open-label, meaning both the researchers and participants will know which medication is being administered, and it will be conducted across multiple centers to gather comprehensive data.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as having type 2 diabetes, being 70 years or older, and having certain cardiovascular conditions.

    Written informed consent is required to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health metrics, including blood sugar levels and other relevant health indicators.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive one of the following medications: Xigduo, Vokanamet, Forxiga, Synjardy, Jardiance, or Invokana.

    All medications are administered orally in the form of film-coated tablets.

    The dosage and specific medication depend on the random assignment and individual health needs.

  4. Step 4

    Ongoing monitoring

    Regular monitoring of blood sugar levels and other health indicators is conducted to ensure safety and effectiveness.

    Participants are observed for any side effects or adverse reactions.

  5. Step 5

    Follow-up assessments

    Periodic assessments are conducted to evaluate changes in health metrics such as blood sugar control, body weight, and blood pressure.

    Adjustments to medication dosage may be made based on these assessments.

  6. Step 6

    Final evaluation

    At the end of the 24-month study period, a final evaluation is conducted to assess the achievement of individualized blood sugar targets without severe hypoglycemia.

    The overall health impact of the medication is reviewed, including any changes in medication satisfaction and safety outcomes.

Who can join the trial?

7 criteria

  • The patient must have Type 2 diabetes.
  • The patient must be 70 years or older.
  • Both men and women can participate.
  • The patient must have established cardiovascular disease, which means they have heart or blood vessel problems, whether they show symptoms or not. Alternatively, they can have an eGFR (a measure of kidney function) less than 90 ml/min/1.73 m² but still above the level where therapy with all SGLT2 inhibitors would start.
  • The patient's HbA1c (a measure of blood sugar levels over time) must be higher than their personalized target value.
  • There must be a clinical reason to start therapy with SGLT2 inhibitors, which are a type of medication for diabetes.
  • The patient must be able to give written informed consent, meaning they understand the study and agree to participate.

Who cannot join the trial?

4 criteria

  • Patients who do not have Type 2 diabetes mellitus cannot participate. This is a condition where the body does not use insulin properly, leading to high blood sugar levels.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to achieve the individualized HbA1c target without experiencing level-3 hypoglycemia cannot participate. HbA1c is a measure of average blood sugar levels over a few months, and level-3 hypoglycemia is a severe drop in blood sugar that requires help from another person.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

  • Empagliflozin

    is a medication used to help control blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove glucose from the bloodstream through urine. In this trial, it is being tested to see how safe and effective it is for elderly patients.

  • Dapagliflozin

    is another medication that helps manage blood sugar levels in individuals with type 2 diabetes. It functions similarly to empagliflozin by aiding the kidneys in eliminating excess glucose from the body. The trial aims to evaluate its safety and efficacy in older adults.

  • Canagliflozin

    is also used to treat type 2 diabetes by lowering blood sugar levels. It works by preventing the kidneys from reabsorbing glucose, thus increasing its excretion in urine. This trial is assessing how well it works and how safe it is for elderly patients.

  • Ertugliflozin

    is a medication that helps control high blood sugar in people with type 2 diabetes. Like the other medications in this trial, it helps the kidneys remove glucose from the blood. The study is focused on understanding its safety and effectiveness in older patients.

What is already known about the treatment

Empagliflozin – Empagliflozin is administered orally in tablet form and is used to manage blood sugar levels in individuals with type 2 diabetes. It is currently well-established in medical practice and literature as an effective treatment option. The main therapeutic indication for empagliflozin is to improve glycemic control in adults with type 2 diabetes. At the molecular level, it works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which reduces glucose reabsorption and increases glucose excretion in the urine. Empagliflozin belongs to the pharmacological class of SGLT2 inhibitors.

Investigated diseases

Type 2 diabetes mellitus – This is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and eventually, the pancreas may not produce enough insulin. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The progression of the disease can be gradual, often starting with prediabetes, where blood sugar levels are higher than normal but not yet high enough to be classified as diabetes. Lifestyle factors such as diet, physical activity, and weight management play a significant role in the development and progression of the disease. Regular monitoring of blood sugar levels is crucial to managing the condition effectively.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-518915-20-00Protocol codeTRS-2019-00002051Estimated enrolment1 167 patientsSponsorCenter For Outcomes Research And Clinical Epidemiology S.r.l.

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