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

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What is this study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
MVZ DiaMedicum Bad Mergentheim GmbH	Bad Mergentheim	Germany

Other Sites

Site Name	City	Country
Gama Diamed S.R.L.	Mangalia	Romania
Diabet2 s.r.o.	Dobris	Czechia
Universita’ Di Pisa	Pisa	Italy
Centro Cardiologico Monzino S.p.A.	Milan	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
InnoDiab Forschung GmbH	Essen	Germany
Nutrilife S.R.L.	Bucharest	Romania
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH	Oldenburg In Holstein	Germany
Clinica Korall S.R.L.	Satu Mare	Romania
Milena Sante S.R.L.	Galati	Romania
Medikals s.r.o.	Piestany	Slovakia
Azienda Socio Sanitaria Locale N 2 Della Gallura	Olbia	Italy
Iridia s.r.o.	Turciansky Peter	Slovakia
Diabdana S.R.L.	Oradea	Romania
MVZ Diabeteszentrum Dr. Tews GmbH	Gelnhausen	Germany
ASL To5	Moncalieri	Italy
ProDia s.r.o.	Povazska Bystrica	Slovakia
JAL s.r.o.	Bratislava	Slovakia
ENDIANT s.r.o.	Hlohovec	Slovakia
ClinPhenomics CVC GmbH	St. Ingbert	Germany
Rkghuzku stfrgx	Prague	Czechia
Mxnti Txgbk Ekjcextiily	Krnov	Czechia
Dpqufqm Dbd Phvveha Avhubqxtmlk Snqspq	Ploiesti	Romania
Ulqxuzyibm Mciit Gwdduwp Ox Cdhnxfglt	Catanzaro	Italy
Ctfulto Mnllrjp Dz Dbogyffoxo Sr Tyjnyhzni Assyqcjzl Nbhckq Suflgq	Brasov	Romania
Dnmbbhtto uhc Sskecjzgpapzyxfxgw Bxyiyv	Bochum	Germany
Mepbi Kstrvb sawryw	Dobris	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	01.11.2022
Germany	Not recruiting	01.11.2022
Italy	Not recruiting	01.11.2022
Romania	Not recruiting	01.11.2022
Slovakia	Not recruiting	01.11.2022

Trial locations

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.

Dulaglutide is an injectable medication used to help regulate blood sugar levels.

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

Lixisenatide is an injectable medication used to help control blood sugar.

Saxagliptin is an oral medication used in the management of blood sugar levels.

Pioglitazone is a medication taken by mouth to help manage blood sugar in people with diabetes.

Metformin and Sulfonamides (specifically Glibenclamide) are oral medications used together or separately as part of conventional therapy to lower blood sugar levels.

Vildagliptin is an oral medication used to help control blood sugar levels.

Alogliptin is an oral medication used as part of standard diabetes care to help manage blood sugar.

Investigated diseases:

Type 2 diabetes mellitus

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 ID:

2022-501073-40-00

Protocol code:

I8F-MC-GPHE

NCT ID:

NCT05433584

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?