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Personalized Diabetes Medication Adjustment for Type 2 Diabetes (CHANGE Trial)

N/A
Recruiting
Led By Mary K Rhee, MD, MSCR
Research Sponsored by Foundation for Atlanta Veterans Education and Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 40-74 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights

CHANGE Trial Summary

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.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if adjusting diabetes medication to maintain normal glucose levels can preserve insulin-producing cell function better than usual care based on HbA1c levels alone. This could slow disease progression and prevent complications.See study design
What are the potential side effects?
Potential side effects from intensified diabetes medications may include low blood sugar (hypoglycemia), weight gain, digestive issues like nausea or diarrhea, skin reactions at injection sites, and possibly edema (swelling).

CHANGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 40 and 74 years old.

CHANGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EFFECT SIZE
β-CELL FUNCTION - #2a
β-CELL FUNCTION - #2b
+1 more
Secondary outcome measures
COST EFFECTIVENESS - to be explored only if additional (ancillary) funding can be obtained
NEPHROPATHY by eGFR
NEPHROPATHY by urine microalbumin/creatinine ratio
+2 more

CHANGE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: USE OF DIABETES Rx GUIDED BY SELF-MONITORED BLOOD GLUCOSE (SMBG)Experimental Treatment1 Intervention
Guidance by SMBG: Glucose goals: We will aim for <100 mg/dl premeal (2), <130 postmeal. Monitoring will include pre-breakfast 2x/wk, and a 5-point profile 1x/wk (before and 1.5-2.5 hr after breakfast, before lunch, before supper, and bedtime). Added Rx will be used if SMBG is >goal ≥3x in 2 consecutive weeks after ≥4 weeks of MOVE! and/or the previous Rx [e.g., any 3 of the 7 goals (<100 mg/dl premeal, <130 post)]. Metformin ER will be given first (if not already on it), and increased to 2000 mg/day if there are no side effects. (If metformin is not tolerated, it will be stopped and the second Rx will become the "first Rx" and given instead. If other Rx are not tolerated, the next Rx will be used. The second Rx will be the TZD pioglitazone, followed by the GLP-1 RA semaglutide, then the SGLT-2 inhibitor empagliflozin. If still above goal, glargine insulin will be added, titrated to keep fasting glucose <100 mg/dl.
Group II: USE OF DIABETES Rx GUIDED LARGELY BY HbA1c LEVELSActive Control1 Intervention
Extended-release [ER] metformin will be added if HbA1c is ≥7.0% after 3 months; if already used and maximized, pioglitazone will be begun. Other Rx will be added each time HbA1c reaches ≥7.5%. The sequence of Rx will be the same as in intensive Rx subjects; those using insulin will also do prebreakfast SMBG, aiming for glucose <100 mg/dl.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,282 Total Patients Enrolled
Emory UniversityOTHER
1,632 Previous Clinical Trials
2,556,351 Total Patients Enrolled
Abbott Diabetes CareIndustry Sponsor
63 Previous Clinical Trials
24,615 Total Patients Enrolled

Media Library

Intensification of diabetes medication based largely on HbA1c levels (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05040087 — N/A
Type 2 Diabetes Research Study Groups: USE OF DIABETES Rx GUIDED LARGELY BY HbA1c LEVELS, USE OF DIABETES Rx GUIDED BY SELF-MONITORED BLOOD GLUCOSE (SMBG)
Type 2 Diabetes Clinical Trial 2023: Intensification of diabetes medication based largely on HbA1c levels Highlights & Side Effects. Trial Name: NCT05040087 — N/A
Intensification of diabetes medication based largely on HbA1c levels (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05040087 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for enrolment in this clinical research?

"This clinical trial is actively enrolling participants, as reported on the website of clinicialtrials.gov. The first posting was on September 1st 2021 and it has been updated most recently on February 14th 2022."

Answered by AI

Can persons over the age of 45 partake in this investigation?

"This medical research is currently welcoming participants aged between 40 and 74 years."

Answered by AI

What is the maximum capacity of participants for this clinical trial?

"Affirmative. According to the data featured on clinicaltrials.gov, this trial is actively enlisting participants; it was initially posted in September 2021 and recently updated in February 2022. 126 individuals are sought at 1 centre for participation."

Answered by AI

Is it possible for me to take part in this research endeavor?

"This trial seeks to recruit 126 participants between the ages of 40 and 74 that have been diagnosed with Type 2 diabetes Mellitus."

Answered by AI

What are the expected results from this research?

"The overarching purpose of this multi-year medical trial (which involves a 3 month washout period) is to evaluate β-cell function as the primary outcome. Secondary objectives encompass point of care glucose analysis through continuous glucose monitoring, an examination of the need for medications based on ROC areas and Youden indices, prediction of initial vs. later medication requirement independent from disease prevalence, nephropathy evaluation via urine microalbumin/creatinine ratio tests every 6 months up until 2.5 years, and cost effectivity should supplementary funding be allocated."

Answered by AI
~49 spots leftby Dec 2025