Not recruiting

Study Comparing Orforglipron and Dapagliflozin for Adults with Type 2 Diabetes and Poor Blood Sugar Control on Metformin

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 does not use insulin properly, leading to high blood sugar levels. The study will compare two treatments: Orforglipron (also known by its code name LY3502970) and Dapagliflozin. Participants in the study will continue their current treatment with Metformin, a common medication used to help control blood sugar levels in people with Type 2 Diabetes.

The purpose of the study is to see if Orforglipron is as effective as Dapagliflozin in managing blood sugar levels. Participants will be randomly assigned to receive either Orforglipron or Dapagliflozin, both taken as capsules by mouth once a day. Some participants may receive a placebo, which looks like the real medication but does not contain the active ingredient. The study will monitor changes in blood sugar levels over time to assess the effectiveness of the treatments.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. The study aims to provide valuable information on how well Orforglipron works compared to Dapagliflozin in people with Type 2 Diabetes who are already taking Metformin. This research could help improve treatment options for managing blood sugar levels in individuals with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, ensure that you have Type 2 diabetes and have been on a stable treatment with metformin for at least 90 days before the study begins.
Confirm that there has been no significant change in body weight for at least 90 days prior to the start of the study and agree not to start an intensive diet or exercise program aimed at weight loss during the study.
Step 2
Randomization
Participants will be randomly assigned to receive either orforglipron or dapagliflozin to compare their effects on blood sugar control.
Step 3
Medication administration
If assigned to the orforglipron group, take the medication orally once daily.
If assigned to the dapagliflozin group, take the medication orally once daily.
Both medications are administered in capsule form.
Step 4
Monitoring and assessments
Regular monitoring of blood sugar levels will be conducted to assess the change from baseline in Hemoglobin A1c (HbA1c), which is a measure of blood sugar control over time.
Additional health assessments may be conducted to ensure safety and efficacy of the treatment.
Step 5
Study duration
The study is expected to continue until July 28, 2025.
Participants are expected to adhere to the study protocol for the entire duration to ensure accurate results.

Who can join the trial?

5 criteria

Have Type 2 Diabetes, which is a condition where the body doesn't use insulin properly, leading to high blood sugar levels.
Have been on a stable diabetes treatment with metformin for at least 90 days before the study starts. Metformin is a common medication used to help control blood sugar levels.
Have not lost or gained body weight for at least 90 days before the study begins and agree not to start an intensive diet or exercise program during the study with the goal of losing weight, except for regular lifestyle or dietary measures for diabetes treatment.
Be within the age range of adults, which typically means 18 years and older.
Both males and females can participate in the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CRS Clinical Research Services Management GmbH
Verified
Berlin, Germany
Institut fuer Diabetesforschung Muenster GmbH
Verified
Munster, Germany
Medizentrum Essen Borbeck
Verified
Essen, Germany

Trial locations

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Investigated drugs

Orforglipron
is an oral medication being studied for its ability to help control blood sugar levels in adults with type 2 diabetes. It is taken once daily and is being compared to another diabetes medication to see if it is as effective in managing blood sugar.
Dapagliflozin
is a medication used to help control blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove sugar from the body through urine. In this study, it is being used as a comparison to evaluate the effectiveness of orforglipron.

What is already known about the treatment

Orforglipron
This medication is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in managing Type 2 Diabetes, particularly in patients who have inadequate glycemic control with metformin. Orforglipron works by mimicking the action of incretin hormones, which help to regulate blood sugar levels by increasing insulin release and decreasing glucagon production. It is classified as a GLP-1 receptor agonist, a type of medication that helps improve blood sugar control in people with Type 2 Diabetes.
Dapagliflozin
This medication is also taken orally as a tablet. It is an established treatment for Type 2 Diabetes and is widely recognized in medical literature for its role in improving glycemic control. Dapagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which leads to the excretion of excess glucose through urine. It belongs to the class of medications known as SGLT2 inhibitors, which are used to lower blood sugar levels in adults with Type 2 Diabetes.

Investigated diseases

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 may initially present with symptoms such as increased thirst, frequent urination, and fatigue. As it progresses, individuals may experience more severe symptoms and complications if blood sugar levels are not managed effectively. Lifestyle factors, such as diet and physical activity, play a significant role in the development and progression of Type 2 Diabetes.