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Changing the Natural History of Type 2 Diabetes ("CHANGE" Study)

NCT05040087 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2025-05-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Intensification of diabetes medication based largely on HbA1c levels

Use of diabetes Rx in controls will be guided largely by HbA1c levels.

OTHER

Intensification of diabetes medication based on glucose levels

Use of diabetes Rx in the intensive Rx groups will be guided by participants' self-monitored blood glucose levels (SMBG), with management aimed to keep glucose levels within the normal range.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Emory University

    collaborator OTHER

  • Abbott Diabetes Care

    collaborator INDUSTRY

  • Foundation for Atlanta Veterans Education and Research, Inc.

    lead OTHER

Principal Investigators

  • Mary K Rhee, MD, MSCR · Emory University School of Medicine, Atlanta VA Medical Center

  • Lawrence S Phillips, MD · Emory University School of Medicine, Atlanta VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2027-01-31
Completion
2027-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05040087 on ClinicalTrials.gov