Personalized Diabetes Medication Adjustment for Type 2 Diabetes
(CHANGE Trial)
Trial Summary
What is the purpose of this trial?
Diabetes is a disorder of high blood glucose, that tends to get worse; over time, patients need more and more drugs. This pattern is caused by overwork of the body's insulin-producing β-cells, because patients' glucose levels are typically above normal; if the investigators kept glucose levels normal - reducing β-cell work - the investigators might be able to keep the disease from getting worse. This trial is aimed to show that adjusting the drugs to keep glucose levels normal, can help to preserve β-cell function compared to usual diabetes care, possibly reduce the tendency to develop the eye and kidney complications of diabetes, and might also be more cost-effective than usual care.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the idea that Personalized Diabetes Medication Adjustment for Type 2 Diabetes is an effective treatment?
The available research shows that using a combination of drugs like linagliptin and metformin can be more effective than using just one drug alone. This combination helps people with type 2 diabetes manage their blood sugar levels better, especially those with higher initial levels. Additionally, empagliflozin, a type of drug used in these personalized adjustments, has shown better long-term control of blood sugar compared to some other drugs. These findings suggest that personalized medication adjustments can be a successful approach for managing type 2 diabetes.12345
What data supports the effectiveness of the drug combination for personalized diabetes medication adjustment in type 2 diabetes?
Research shows that combining linagliptin and metformin is more effective than using either drug alone for managing blood sugar levels in type 2 diabetes, especially in patients with higher initial HbA1c levels. Additionally, empagliflozin has been found to offer better long-term blood sugar control compared to some other diabetes medications.12345
What safety data exists for personalized diabetes medication adjustment for Type 2 Diabetes?
The safety data for personalized diabetes medication adjustment, which includes drugs like metformin, dapagliflozin, semaglutide, saxagliptin, empagliflozin, linagliptin, and canagliflozin, shows that these medications generally have a favorable safety profile. Combination therapies such as saxagliptin and dapagliflozin are noted for their benefits in glycemic control without significant risks of weight gain or hypoglycemia. Saxagliptin/metformin combinations are considered safe for patients with cardiovascular disease, elderly patients, and those with impaired renal function, with few adverse events reported. Semaglutide has shown high efficacy in lowering HbA1c with a safety profile similar to other antidiabetic agents, primarily causing gastrointestinal side effects. Overall, these medications are considered safe with manageable side effects, making them suitable for personalized diabetes management.46789
Is the personalized diabetes medication adjustment for Type 2 Diabetes safe for humans?
The combination of medications like saxagliptin and metformin has been shown to be safe for people with diabetes, including those with heart disease and kidney issues, with very few side effects. Newer diabetes drugs like semaglutide have a similar safety profile, with most side effects being mild and related to the stomach, and no serious reactions reported.46789
Is adjusting diabetes medication based on glucose levels a promising treatment for type 2 diabetes?
How is the personalized diabetes medication adjustment treatment different from other treatments for type 2 diabetes?
This treatment is unique because it personalizes medication adjustments based on individual HbA1c (a measure of blood sugar control over time) and glucose levels, potentially improving outcomes by tailoring therapy to each patient's specific needs, unlike standard treatments that may not consider these individual variations.310111213
Research Team
Mary K Rhee, MD, MSCR
Principal Investigator
Emory University School of Medicine, Atlanta VA Medical Center
Lawrence S Phillips, MD
Principal Investigator
Emory University School of Medicine, Atlanta VA Medical Center
Eligibility Criteria
This trial is for adults aged 40-74 with Type 2 Diabetes, having specific glucose levels and HbA1c between 6.0-7.4%. It's not for those who've had bariatric surgery, severe kidney issues, dementia, recent heart problems or pancreatitis, are pregnant or extremely overweight.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Establish tolerance to metformin and adherence to self-monitoring of blood glucose
Treatment
Participants receive lifestyle intervention and randomized to intensive or control treatment arms with regular monitoring
Washout
A 3-month period to assess the sustainability of β-cell function post-treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Intensification of diabetes medication based largely on HbA1c levels
- Intensification of diabetes medication based on glucose levels
Intensification of diabetes medication based largely on HbA1c levels is already approved in European Union, United States, Canada, Japan, China for the following indications:
- Type 2 diabetes mellitus
- Type 2 diabetes mellitus
- Heart failure
- Chronic kidney disease
- Type 2 diabetes mellitus
- Weight management
- Type 2 diabetes mellitus
- Type 2 diabetes mellitus
- Heart failure
- Type 2 diabetes mellitus
- Type 2 diabetes mellitus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Foundation for Atlanta Veterans Education and Research, Inc.
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Emory University
Collaborator
Abbott Diabetes Care
Industry Sponsor
Robert B. Ford
Abbott Diabetes Care
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Dr. Mahmood Kazemi
Abbott Diabetes Care
Chief Medical Officer
Bachelor's and Master's degrees from Stanford University, MD from the University of California, San Francisco