Fast Facts
Untreated Type 2 Diabetes
• Have a Current A1C of 7-10.5
• Have Obesity
Compensation Provided
Conducted in Needham, MA
Study Background
This study is designed to explore how different interventions may impact individuals with type 2 diabetes who have not yet started treatment. By focusing on participants with an A1C between 7 and 10.5, researchers aim to assess both the safety and effectiveness of potential treatment strategies while gaining valuable insights into diabetes management.
Type 2 diabetes is a progressive condition that, if left untreated, can lead to serious health complications, including heart disease, nerve damage, and kidney issues. While several medications are available, researchers are continuously working to improve treatment options. This study provides an opportunity for participants to contribute to meaningful advancements in diabetes care while receiving thorough medical evaluations, including DXA scans, EKGs, bloodwork, and other assessments—all at no cost. The findings from this trial may help shape future diabetes treatments, offering better outcomes for those affected by the disease.
Study Background
This study is designed to explore how different interventions may impact individuals with type 2 diabetes who have not yet started treatment. By focusing on participants with an A1C between 7 and 10.5, researchers aim to assess both the safety and effectiveness of potential treatment strategies while gaining valuable insights into diabetes management.
Type 2 diabetes is a progressive condition that, if left untreated, can lead to serious health complications, including heart disease, nerve damage, and kidney issues. While several medications are available, researchers are continuously working to improve treatment options. This study provides an opportunity for participants to contribute to meaningful advancements in diabetes care while receiving thorough medical evaluations, including DXA scans, EKGs, bloodwork, and other assessments—all at no cost. The findings from this trial may help shape future diabetes treatments, offering better outcomes for those affected by the disease.
Additional Information
This study is being conducted to evaluate the safety and effectiveness of a new medication to treat individuals with type 2 diabetes who have overweight or obesity. Researchers aim to understand how these treatments impact both weight regulation and diabetes management, with the goal of improving future treatment options for people living with type 2 diabetes and its associated health risks.
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Untreated type 2 diabetes
- Metformin OK
- Have a current A1C of 7-10.5
- Have obesity or overweight (BMI ≥27 kg/m2)
- Have had a stable weight body weight for the past 3 months
Exclusion Criteria:
- Taking a weight loss medication
- Have type 1 diabetes
- Taking insulin
- Pancreatitis
- Recent heart attack, stroke, or heart failure
- Prior or planned surgery for obesity
Here’s what you can expect if you participate in this study.
Screening Period (6 weeks):
- You will attend 3 on-site visits during the screening period.
- Procedures during these visits may include:
- DXA scan
- EKG
- Blood draws
- Bioimpedance scale measurements
- Questionnaires
- If you’re taking metformin, you must be willing to stop taking it for the duration of the study
These assessments are fully covered by the study, and you will be compensated for your time. After the screening, the information will be reviewed, and if there are no issues, you will be randomized into the main trial.
Main Study (48 weeks):
- The study will last 48 weeks, requiring 12-13 on-site visits.
- Visits will last anywhere from 30 minutes to 2 hours.
- You can expect to undergo:
- Bioelectrical impedance analysis
- Vital sign checks
- Blood sample collection
- Diet and exercise planning
- Study visits will be a mix of on-site and telehealth
Placebo-Controlled Trial:
- Since this is a placebo-controlled trial, there’s a chance you may receive a placebo instead of the active medication.
- If your main goal is to receive medication, this may not be the right study for you.
- We encourage you to complete all 48 weeks of the study, as both placebo and non-placebo data are essential to the success of the study.
Locations:
- The study is being conducted at a location in Needham, MA.
- A second location will open in Woburn, MA by the end of 2025, closer to the NH border.
Withdrawal:
- You are free to withdraw from the study at any time, but you must inform the study team if you choose to do so.
Compensation for each visit varies based on what is required, and full details will be provided during the consenting process. Travel expenses are reimbursed, and if you need transportation, Uber can be coordinated and paid for by the study site.
There is no cost for you to participate in our research study.
