Basal Plus GLP1-ra on Glycemic Variability in CKD

Last updated: November 29, 2024
Sponsor: Elaine Chow
Overall Status: Completed

Phase

4

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetic Kidney Disease

Treatment

Continuous glucose monitor

Insulin Degludec

Dulaglutide

Clinical Study ID

NCT05218915
BGLP-DKD
  • Ages 18-75
  • All Genders

Study Summary

To compare GLP-1 RA plus basal insulin (BGLP) versus basal-bolus (BB) insulin regimens on glycemic variability (GV) and time in range (TIR) in diabetes patients CKD stage 3-4

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Type 2 diabetes mellitus diagnosed for at least 6 months

  2. Male or female age ≥ 18 years old and ≤ 75 years old.

  3. Body mass index between 18 and 40 kg/m2 inclusive

  4. HbA1c ≥ 6.5% and ≤ 9.0% at screening

  5. Women who are not pregnant, lactating or planning a pregnancy during theirparticipation in the clinical study.

  6. Patients with CKD stage 3 or 4 as defined by estimated glomerular filtration ratebetween 15-59 ml/min/m2 by the modified Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) equation at screening

  7. Willingness, ability and commitment to comply with the testing, procedure andfollow-up outlined in this protocol including (but not limited to) and use ofpre-specified glucose monitoring devices.

  8. In the opinion of the investigator, absence of any physical limitations, addictivediseases, or underlying medical conditions (including mental health) that maypreclude the patient from being a suitable study candidate.

  9. Written informed consent to participate in the study provided by the patient.

  10. Willing and capable of use of a continuous glucose monitor as judged by theinvestigator

Exclusion

Exclusion Criteria:

  1. Type 1 diabetes

  2. Currently pregnant, as demonstrated by a positive pregnancy test at screening orplanning pregnancy

  3. Treatment with GLP-1 RA or insulin degludec in the past three months

  4. Any active acute or chronic disease or condition that, in the opinion of theinvestigator, might interfere with the performance of this study.

  5. Any active acute or chronic infectious disease that, in the opinion of theinvestigator, would pose an excessive risk to study staff.

  6. Current use or recent exposure to any medication that in the opinion of theinvestigator could have an influence on the patient's ability to participate in thisstudy or on the performance of the test device.

  7. Extensive skin changes/diseases that preclude wearing the CGM on normal skin at theproposed application sites (e.g., extensive psoriasis, recent burns or severesunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitisherpetiformis).

  8. Have a known allergy to medical-grade adhesives

  9. Known current or recent alcohol or drug abuse

  10. Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction inthe six months prior to screening

  11. Patients on renal replacement therapy or likely require kidney transplant ordialysis during the study period

  12. Currently participating in another investigational study protocol where the testingor results may interfere with study compliance, diagnostic results, or datacollection.

  13. An identified protected vulnerable patient (including but not limited to those indetention, or a prisoner).

Study Design

Total Participants: 95
Treatment Group(s): 3
Primary Treatment: Continuous glucose monitor
Phase: 4
Study Start date:
January 28, 2022
Estimated Completion Date:
October 30, 2024

Connect with a study center

  • Prince of Wales Hospital

    Sha Tin,
    Hong Kong

    Site Not Available

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