Not recruiting

Study comparing semaglutide and dapagliflozin taken separately or combined in one tablet for type 2 diabetes patients

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 study is investigating Type 2 Diabetes Mellitus, a condition where the body does not properly use insulin, leading to high blood sugar levels. The study will use two medications: semaglutide, which helps control blood sugar by affecting how the body produces insulin and slows digestion, and dapagliflozin, which helps remove excess sugar from the body through urine. The purpose of the study is to understand how these two medications work in the body when taken together in one tablet compared to when they are taken separately.

During the study, participants will receive different combinations of semaglutide and dapagliflozin in tablet form. Some participants will take the medications separately, while others will take them combined in a single tablet. The tablets will be taken by mouth and will contain varying doses of the medications. The study will measure how the body absorbs and processes these medications by taking blood samples at specific times to check the levels of semaglutide and dapagliflozin in the blood.

The researchers will compare the concentration of each medication in the blood when taken separately versus when taken together to determine if the medications affect each other's activity in the body. This information will help understand whether combining both medications in one tablet is as effective as taking them separately. The study involves healthy participants who will be monitored throughout the treatment period to collect the necessary data about how these medications work in the body.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial health assessment
A physical examination will be performed to evaluate your overall health status
Your vital signs will be checked and an electrocardiogram (heart rhythm test) will be conducted
Laboratory tests will be performed to confirm your eligibility for the study
Step 2
Medication phase - single components
You will receive either semaglutide tablets (1.5 mg, 4 mg, or 9 mg) or dapagliflozin tablets (10 mg) to take by mouth
The medication will be taken daily until reaching a steady state in your body
Blood samples will be collected over 24 hours to measure drug levels in your system
Step 3
Medication phase - combination tablet
You will receive a combination tablet containing both medications in one of three dose combinations:
- semaglutide/dapagliflozin 1.5/10 mg
- semaglutide/dapagliflozin 4/10 mg
- semaglutide/dapagliflozin 9/10 mg
The tablet will be taken by mouth daily until reaching a steady state
Blood samples will be collected over 24 hours to measure drug levels in your system
Step 4
Final assessment
A final health evaluation will be conducted
The study will conclude after completing all required blood sampling periods

Who can join the trial?

9 criteria

You must be either male or female
Your age must be between 18 and 64 years old when you sign the consent form
Your body mass index (BMI) must be between 20.0 and 29.9 (BMI is a measure of body fat based on height and weight)
You must be in generally good health, which will be determined through:
- Review of your medical history
- Physical examination
- Vital signs check (such as blood pressure and heart rate)
- Electrocardiogram (a test that records your heart's electrical activity)
- Clinical laboratory tests (blood and other medical tests)
- The study doctor must confirm that you are healthy enough to participate based on all these assessments

Who cannot join the trial?

15 criteria

History of type 1 diabetes or other types of diabetes besides type 2
Known allergies to study medications (semaglutide or dapagliflozin) or their components
Current participation in other clinical trials
Significant heart, kidney, or liver problems
History of pancreatitis (inflammation of the pancreas)
Pregnant or breastfeeding women
Active infections or major illnesses
Use of medications that could interfere with the study drugs
History of alcohol or drug abuse within the past year
Body mass index (BMI) outside the required range
Abnormal blood pressure or heart rhythm
History of severe gastrointestinal diseases
Recent surgery or planned surgical procedures
Blood donation within 3 months before the study
Mental conditions that could affect study participation

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Verified sites

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PAREXEL International GmbH
Verified
Berlin, Germany

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Investigated drugs

Semaglutide is a medication used to treat type 2 diabetes and manage weight. It works by helping the body produce more insulin when blood sugar is high and reducing appetite. It belongs to a class of medications called GLP-1 receptor agonists, which mimic a natural hormone that regulates blood sugar and hunger signals. Dapagliflozin is a medication used to treat type 2 diabetes and certain heart conditions. It works by helping the kidneys remove excess sugar from the blood through urine. It belongs to a class of medications called SGLT2 inhibitors, which help lower blood sugar levels and can also provide benefits for heart and kidney health. The trial studies these medications both individually and in a fixed-dose combination to understand how they interact with each other in the body when taken together, compared to when they are taken separately.

What is already known about the treatment

Semaglutide
An oral medication used to treat type 2 diabetes that belongs to the GLP-1 receptor agonist class of drugs. This prescription medicine works by mimicking the effects of the natural hormone GLP-1, helping to regulate blood sugar levels by stimulating insulin production and reducing glucagon secretion when blood sugar is high. The medication comes in tablet form for once-daily oral administration and has shown significant effectiveness in controlling blood glucose levels while also supporting weight management in clinical studies.
Dapagliflozin
An oral medication for type 2 diabetes management that belongs to the SGLT2 inhibitor class of drugs. This prescription medicine works by helping the kidneys remove excess sugar from the body through urination, effectively lowering blood glucose levels independently of insulin action. The medication is taken once daily in tablet form and has demonstrated effectiveness in improving glycemic control while offering additional benefits such as modest weight loss and potential cardiovascular risk reduction in clinical trials.

Investigated diseases

Type 2 Diabetes Mellitus - A chronic metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin or reduced insulin production. The condition typically develops gradually over several years, often beginning with insulin resistance, where body cells don't respond effectively to insulin. It commonly appears in adults and is associated with factors such as excess weight, physical inactivity, and genetic predisposition. The body either doesn't produce enough insulin or becomes resistant to its effects, leading to elevated blood glucose levels. Over time, this condition affects how the body processes carbohydrates, fats, and proteins.