Study Details

Open

Diabetes study for patients with diabetes and renal impairment who are currently using basal insulin with or without Metformin or SGLT2 inhibitors

This study aims to investigate the effectiveness and safety of retatrutide, a new diabetes medication) at doses of 4 mg, 9 mg, or 12 mg that will be taken as a weekly injection for about 1 year, compared to a placebo. A participant's change in HbA1c level will be primary outcome of interest. We are seeking participants with type 2 diabetes that has affected kidney function and are currently taking long-acting insulin with metformin and/or a SGLT2 inhibitor.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

What will be asked of you

The study involves 21 study visits over the course of 1 year with a safety follow up visit following visit 21. Of the 21 visits, 5 of the visits will occur via telehealth and most visits are expected to last approximately one hour, but some may take longer. Visits will include completion of assessments covering your medical history and current medication regimen, surveys, lab draws, vital signs, measurement of height, weight, and waist circumference. At a few visits, you may also receive a physical exam and an ECG. Completion of blood sugar diaries, hypoglycemia diaries, and wearing a continuous glucose monitor at certain times throughout the study are also required. If you choose to participate, we will ask that you are able attend all in-person visits at 100 Eastowne Drive in Chapel Hill.

Incentives

$84-$420 per visit, travel reimbursement

In-person visits:
16

Phone or online visits:
5

Total length of participation:
1 year

Looking for Specific Volunteers

Able to participate:

A1c between 7.0% and 10.5%
Moderate or severe renal impairment (GFR between 15 and 60)
Uses over 20 units of basal insulin per day either alone or in addition to Metformin and/or a SGLT2 inhibitor
Have a stable weight over last 90 days and BMI of at least 23.0
Are willing perform, finger-stick blood sugars, maintain study diaries, complete questionaries, and wear a blinded CGM during various time periods.

Not eligible if:

Have type 1 diabetes
Have a history of severe hypoglycemia or ketoacidosis in last 6 months
Have prior or planned surgery for obesity
Have had a heart attack, stroke, or heart failure requiring hospitalization in the last 90 days
Have been treated with any other diabetes medication (other than basal insulin, metformin, or SGLT2 inhibitor) within the last 90 days

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Klara Klein
Medicine-Endocrinology

Study Type

Clinical or Medical
Interventional

Study Topics

Chronic Conditions
Diabetes
Kidneys and Liver

IRB Number

24-0423

ClinicalTrials.gov

NCT06297603