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Study Summary
This trial is testing whether semaglutide can help control blood sugar and weight in people with type 2 diabetes who are also overweight, when taken with metformin. It will compare different doses of semaglutide, given by injection, to placebo (a dummy medicine). The trial will last for 52 weeks, with participants having 13 clinic visits and 4 phone calls.
- Type 2 Diabetes
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT04189848Trial Design
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- You weigh more than what is considered healthy for your height.Your HbA1c level is between 7.0% and 10.5%.Anyone can participate, regardless of gender.Your diabetic eye condition is not under control, and you have not had a recent eye exam to check for any problems.You have been diagnosed with type 2 diabetes for at least 180 days before the screening.Your kidneys are not working well, as shown by a test called eGFR with a value of less than 30 mL/min/1.73 m² at screening.You have been taking the same amount of metformin every day for at least 90 days before screening.Your HbA1c level is between 7.0% and 10.5%.You have been diagnosed with type 2 diabetes for at least 180 days before the screening.You have a body mass index (BMI) of 27 or higher.You are taking metformin for more than 90 days prior to the day of screening.
- Group 1: Semaglutide 8 mg
- Group 2: Semaglutide 2 mg
- Group 3: Semaglutide placebo 2 mg
- Group 4: Semaglutide placebo 8 mg
- Group 5: Semaglutide 16 mg
- Group 6: Semaglutide placebo 16 mg
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the upper bound of individuals included in this clinical experiment?
"Affirmative. Clinicaltrials.gov's database reflects that this clinical trial, which was first listed on August 8th 2022, is actively recruiting applicants. Around 240 people need to be enrolled from 55 distinct medical centres."
Are there any slots left to join this trial?
"According to the details on clinicaltrials.gov, this experiment is still searching for participants and was initially posted on August 8th 2022 before being updated on November 10th of said year."
To what extent can Semaglutide be detrimental to human health?
"Semaglutide has been evaluated for safety, and based on our assessment at Power the risk-level is rated a 2. This pharmaceutical is currently in its Phase 2 trials, so there are some data that suggest it can be tolerated by patients but not enough to show whether or not it works effectively."
Do I meet the criteria to partake in this research endeavor?
"This research project is seeking 240 individuals with type 2 diabetes mellitus, spanning between 18 and 64 years of age. To qualify, candidates must be male or female, have been diagnosed at least 180 days prior to screening day, possess a Glycosylated haemoglobin (HbA1c) rate ranging from 7.0 - 10.5 percentage (%) [53 - 91 millimoles per mole (mmol/mol)] , Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2), and taking the same metformin dosage for at least 90 days before their screening date"
Is senior citizen participation permissible in this clinical investigation?
"According to the trial's standards, participants must be aged between 18 and 64 in order for them to qualify."
How many medical centers are currently carrying out this experiment?
"Currently, 55 different clinics are recruiting patients for this medical trial. These sites span from Lancaster to Green Bay and Rockville - ensuring that individuals have the opportunity to enroll at a nearby clinic with reduced travel requirements."
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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How responsive is this trial?
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Average response time
- < 2 Days
Most responsive sites:
- Novo Nordisk Investigational Site: < 48 hours
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