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Evaluation of Long-Term Efficacy and Safety of Tirzepatide Versus Intensified Conventional Care in Early Treatment of Type 2 Diabetes in Adults

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 treatment of Type 2 Diabetes, a condition where the body struggles to regulate blood sugar levels effectively. The study will compare a new treatment called tirzepatide with the usual care methods that are typically intensified over time. Tirzepatide is administered as a solution for injection and is being tested to see if it is as effective as the conventional care in managing blood sugar levels over a long period.

The purpose of the study is to evaluate the long-term effectiveness and safety of tirzepatide in adults who are starting treatment early in their Type 2 Diabetes journey. Participants will be monitored for changes in their blood sugar levels, specifically looking at Hemoglobin A1c (HbA1c), which is a common measure of blood sugar control. The study will last for about 104 weeks, during which participants will receive either tirzepatide or the intensified conventional care.

Throughout the study, participants will receive regular check-ups to monitor their health and the effectiveness of the treatment. The goal is to determine if tirzepatide can provide a similar or better outcome in managing Type 2 Diabetes compared to the traditional methods. This research aims to offer insights into new treatment options for individuals with this condition.

The research process

The trial runs in 1 step.

  1. Step 1

    Study participation and treatment

    After joining the study, one of two treatment paths is followed to manage type 2 diabetes, which is a condition affecting how the body processes blood sugar.

    In the first path, tirzepatide is administered via subcutaneous use, which means the medication is injected under the skin using a pre-filled pen. The dose is 15 mg.

    In the second path, intensified conventional care is provided. This involves various background medications to manage blood sugar. These may include oral tablets or injections.

    Oral medications used in the background care include sitagliptin (100 mg), linagliptin (5 mg), saxagliptin (5 mg), vildagliptin (100 mg), alogliptin (25 mg), metformin (3000 mg), or pioglitazone (45 mg).

    Injectable medications used in the background care include albiglutide (50 mg), semaglutide (2 mg), exenatide (2 mg or 20 mcg), dulaglutide (4.5 mg), or liraglutide (3 mg).

    The total duration of the treatment period is monitored up to week 104 to evaluate the change in hemoglobin a1c, which is a measure of average blood sugar levels over time.

Who can join the trial?

5 criteria

  • You must have been diagnosed with Type 2 Diabetes, which is a condition where your body does not use insulin properly, within the last 4 years.
  • Your HbA1c level, which is a blood test that shows your average blood sugar levels over the past two to three months, must be between 7% and 9.5%.
  • You must have been taking a steady dose of metformin, a common medicine used to manage blood sugar, for at least 90 days before starting the study.
  • The amount of metformin you take must be at least 1500 mg per day, unless you cannot take that much due to intolerance, which means your body has a bad reaction to the medicine.
  • If you are taking a dose lower than 1500 mg per day, it must be because you cannot tolerate the full amount.

Who cannot join the trial?

8 criteria

  • You cannot participate if you have Type 1 diabetes, which is a condition where the body does not produce insulin.
  • You cannot participate if you have ever had pancreatitis, which is inflammation or swelling of the pancreas, either suddenly (acute) or over a long period (chronic).
  • You cannot participate if you have certain eye problems caused by diabetes, such as proliferative diabetic retinopathy (where new, abnormal blood vessels grow in the eye), diabetic macular edema (swelling in the part of the eye responsible for central vision), or any eye condition that requires immediate treatment.
  • You cannot participate if a doctor believes you are at high risk for cardiovascular disease (heart and blood vessel problems) or if you have a history of heart attack, stenting (placing a small tube to keep an artery open), stroke, or congestive heart failure (a condition where the heart cannot pump blood effectively).
  • You cannot participate if you or a family member has a history of medullary thyroid carcinoma (a specific type of thyroid cancer) or multiple endocrine neoplasia syndrome type 2 (a genetic condition that causes tumors in various glands).
  • You cannot participate if you have used any medications, including over-the-counter or natural remedies, meant for weight loss within the last 90 days.
  • You cannot participate if your eGFR is less than 30 mL/minute/1.73 m2; eGFR is a measurement used to determine how well your kidneys are filtering waste from your blood.
  • You cannot participate if you have previously used insulin or GLP-1 receptor agonists (a type of injectable medication for diabetes), unless the insulin was used for a very short time due to pregnancy or a temporary illness.
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Investigated drugs

  • Tirzepatide

    is the primary medication being tested in this study. It is administered through an injection under the skin to help manage blood sugar levels in adults with type 2 diabetes.

  • Sitagliptin

    is a medication taken by mouth that is used as part of the standard care to help lower blood sugar levels.

  • Linagliptin

    is an oral medication used as part of the standard treatment to help control blood sugar.

  • Albiglutide

    is a medication given by injection to help manage blood sugar levels.

  • Semaglutide

    is a medication used to help control blood sugar, which can be taken either as an injection or as a pill by mouth.

  • Exenatide

    is a medication administered via injection to assist in blood sugar management.

What is already known about the treatment

  • Sitagliptin

    This medication is taken orally as a pill to help manage blood sugar levels in people with type 2 diabetes. It is widely used in clinical practice and belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by preventing the breakdown of natural hormones that help the body release insulin when needed.

  • Linagliptin

    This is an oral medication used as a standard treatment for adults with type 2 diabetes. It is classified as a DPP-4 inhibitor, meaning it works by increasing the levels of specific hormones that stimulate insulin production. By slowing the breakdown of these hormones, it helps keep blood sugar levels stable.

  • Albiglutide

    This medication is administered through regular injections to treat type 2 diabetes. It is a glucagon-like peptide-1 (GLP-1) receptor agonist, a class of drugs that mimics natural hormones to stimulate insulin release. At a molecular level, it activates specific receptors to improve how the body handles sugar after meals.

  • Tirzepatide

    This is a test substance in this study, administered as a solution via a subcutaneous injection using a pre-filled pen. It is used to treat type 2 diabetes and belongs to a new class of dual hormone agonists. It works by simultaneously targeting two different hormone receptors to improve insulin secretion and regulate blood sugar.

  • Semaglutide

    This medication is available as either an oral pill or an injectable solution for the management of type 2 diabetes. It is a GLP-1 receptor agonist that mimics a hormone naturally produced in the body. It functions by stimulating the pancreas to release more insulin and helping to reduce the amount of sugar produced by the liver.

  • Exenatide

    This is an injectable medication used to help control blood sugar in patients with type 2 diabetes. It belongs to the GLP-1 receptor agonist pharmacological class. It works at the molecular level by activating receptors that signal the body to produce more insulin in response to food.

Investigated diseases

Type 2 Diabetes - This condition occurs when the body cannot properly use insulin or cannot produce enough of it to maintain healthy blood sugar levels. Over time, the body's cells become less responsive to insulin, a state known as insulin resistance. As the disease progresses, the pancreas may eventually struggle to keep up with the demand for insulin. This leads to a gradual and persistent rise in glucose levels within the bloodstream.
Trial detailsLast updated 15 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501073-40-00Protocol codeI8F-MC-GPHEEstimated enrolment781 patientsSponsorEli Lilly & Co.

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