Study of Orforglipron for Adults with Type 2 Diabetes and Poor Blood Sugar Control on Insulin Glargine, with or without Metformin and/or SGLT-2 Inhibitor

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called orforglipron (also known by its code name LY3502970) for people with Type 2 Diabetes. Type 2 Diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels. The study is designed for participants who are currently using insulin glargine, a type of insulin used to control blood sugar, and may also be taking other diabetes medications like metformin or SGLT-2 inhibitors. SGLT-2 inhibitors are a class of drugs that help lower blood sugar by causing the kidneys to remove sugar from the body through urine.

The purpose of this study is to determine how safe and effective orforglipron is in managing blood sugar levels compared to a placebo. Participants will take orforglipron once daily in the form of a capsule. The study will be conducted over a period of time, during which participants will be monitored to see how well their blood sugar levels are controlled and to check for any side effects. The study aims to show that orforglipron is better than a placebo in controlling blood sugar levels.

Participants in the study will continue their current diabetes treatment with insulin glargine, and possibly metformin or SGLT-2 inhibitors, while adding orforglipron or a placebo to their regimen. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving orforglipron and who is receiving the placebo, to ensure unbiased results. This trial will help researchers understand if orforglipron can be a beneficial addition to the treatment options for people with Type 2 Diabetes who are not achieving adequate blood sugar control with their current medications.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose, which is to evaluate the safety and effectiveness of orforglipron in managing blood sugar levels in individuals with Type 2 Diabetes.

Participants must have Type 2 Diabetes and be using insulin glargine, with or without metformin and/or an SGLT-2 inhibitor, to qualify for the study.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying the use of a consistent dose of injectable diabetes medication for at least three months and possibly up to two oral diabetes medications for the same duration.

Participants must have high blood sugar levels to be eligible.

3 randomization

Participants will be randomly assigned to receive either orforglipron or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

4 medication administration

Participants will take the assigned medication once daily by mouth. The specific dosage and duration will be determined by the study protocol.

The study will compare the effects of orforglipron with a placebo to assess its impact on blood sugar control.

5 ongoing monitoring

Regular monitoring will occur throughout the study to track blood sugar levels and any side effects. This ensures the safety and well-being of participants.

Participants may be required to attend scheduled visits for assessments and to provide feedback on their health status.

6 completion of the study

The study is expected to conclude by June 25, 2025. At the end of the study, participants will undergo a final assessment to evaluate the overall effectiveness and safety of orforglipron compared to the placebo.

Results will contribute to understanding the potential benefits of orforglipron for individuals with Type 2 Diabetes.

Who Can Join the Study?

Have Type 2 Diabetes, which is a condition where the body doesn’t use insulin properly.
Be taking a consistent dose of a diabetes drug by injection for at least 3 months.
May be taking up to 2 diabetes drugs by mouth for at least 3 months.
Have a high blood sugar level.

Who Cannot Join the Study?

Individuals who do not have Type 2 Diabetes cannot participate. Type 2 Diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Participants must have difficulty controlling their blood sugar levels even when using insulin glargine, with or without other medications like metformin or SGLT-2 inhibitors. Insulin glargine is a type of insulin used to control blood sugar, metformin is a medication that helps control blood sugar levels, and SGLT-2 inhibitors are drugs that help the kidneys remove sugar from the body through urine.
Individuals who are not within the specified age range cannot participate. The age range for this study is typically adults.
Both males and females can participate, but individuals who do not identify as either may not be eligible.
Individuals who are considered part of a vulnerable population may not be eligible. Vulnerable populations can include groups like pregnant women, children, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia	Baia Mare	Romania

Other Sites

Site Name	City	Country
Nutrilife S.R.L.	Bucharest	Romania
Clinica Korall S.R.L.	Satu Mare	Romania
Diabdana S.R.L.	Oradea	Romania
Milena Sante S.R.L.	Galati	Romania
Diamed Obesity S.R.L.	Galati	Romania
Societatea Civila Medicala Dr. Paveliu	Bucharest	Romania
Easydiet S.R.L.	Bucharest	Romania
Dvbcluwcqkiqbk Spulkq	Targu Mures	Romania
Cmacvbu Mowidyt Dw Dleuopiblq Sg Tuhvdyqes Asfkauzws Nabese Swcexa	Brasov	Romania

Trial status

Country	Status	Recruitment Start
Romania	Not recruiting	07.02.2024

Trial locations

Investigated drugs:

Orforglipron is an oral medication being studied for its ability to help control blood sugar levels in people with Type 2 Diabetes. It is taken once daily and is being compared to a placebo to see how well it works and how safe it is for patients who are already using insulin glargine, with or without other diabetes medications.

Insulin Glargine is a long-acting insulin used to help control blood sugar levels in people with diabetes. It is typically injected once a day and helps to keep blood sugar levels stable over a 24-hour period.

Metformin is a common medication used to help control blood sugar levels in people with Type 2 Diabetes. It works by decreasing the amount of sugar produced by the liver and increasing the sensitivity of muscle cells to insulin.

SGLT-2 Inhibitors are a class of medications that help lower blood sugar levels in people with Type 2 Diabetes. They work by preventing the kidneys from reabsorbing sugar back into the blood, allowing it to be removed from the body through urine.

Investigated diseases:

Type 2 diabetes mellitus

Type 2 Diabetes – Type 2 Diabetes 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, kidneys, eyes, and nerves. The disease often develops gradually and is more common in adults, although it is increasingly seen in younger individuals. Lifestyle factors such as diet, physical activity, and weight play a significant role in its development. Managing blood sugar levels is crucial to prevent complications associated with this condition.

Trial ID:

2023-507280-18-00

Protocol code:

J2A-MC-GZGW

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Orforglipron for Adults with Type 2 Diabetes and Poor Blood Sugar Control on Insulin Glargine, with or without Metformin and/or SGLT-2 Inhibitor

What is this study about?

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