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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

Must not have

Pancreatitis

Family or personal history of multiple endocrine neoplasia 2a

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2.5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 74 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have pancreatitis.

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I have a family or personal history of MEN2A.

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I am currently taking steroid medications.

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I have been diagnosed with dementia.

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I have had weight loss surgery.

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I had a cardiovascular event in the last year.

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My kidney function is reduced with an eGFR of 50 ml/min or less.

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I experience severe chest pain frequently.

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My heart condition is in an advanced stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EFFECT SIZE

β-CELL FUNCTION - #2a

β-CELL FUNCTION - #2b

+1 more

Secondary study objectives

COST EFFECTIVENESS - to be explored only if additional (ancillary) funding can be obtained

NEPHROPATHY by eGFR

NEPHROPATHY by urine microalbumin/creatinine ratio

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: USE OF DIABETES Rx GUIDED BY SELF-MONITORED BLOOD GLUCOSE (SMBG)Experimental Treatment1 Intervention

1. Guidance by SMBG: 2. Glucose goals: We will aim for \<100 mg/dl premeal (2), \<130 postmeal. 3. 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). 4. 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.

0 / 10Eligibility criteria met