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CompletedNCT05218915Updated Dec 3, 2024

Basal Plus GLP1-ra on Glycemic Variability in CKD

A Phase 4 interventional study of Dulaglutide and Insulin Degludec in Diabetes Mellitus and Diabetic Kidney Disease, sponsored by Elaine Chow. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Elaine Chow · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2024, 1 year 11 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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

02

Conditions studied

  • Diabetes Mellitus
  • Diabetic Kidney Disease
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 95 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Elaine Chow is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 their participation in the clinical study.
  6. Patients with CKD stage 3 or 4 as defined by estimated glomerular filtration rate between 15-59 ml/min/m2 by the modified Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening
  7. Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) and use of pre-specified glucose monitoring devices.
  8. In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude 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 the investigator

Exclusion criteria

Exclusion Criteria:

  1. Type 1 diabetes
  2. Currently pregnant, as demonstrated by a positive pregnancy test at screening or planning 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 the investigator, might interfere with the performance of this study.
  5. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
  6. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
  7. Extensive skin changes/diseases that preclude wearing the CGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
  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 in the six months prior to screening
  11. Patients on renal replacement therapy or likely require kidney transplant or dialysis during the study period
  12. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
  13. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    GLP1-ra plus basal insulin (BGLP)

    Dulaglutide and insulin degludec in combination with CGM

    Drug: Dulaglutide · Drug: Insulin Degludec · Device: Continuous glucose monitor

  • Active comparator
    Basal bolus insulin (BB)

    Insulin aspart/lispro and insulin degludec in combination with CGM

    Drug: Insulin Degludec · Device: Continuous glucose monitor

Interventions

  • Dulaglutide once weekly subcutaneous

  • Insulin degludec once daily

  • DeviceContinuous glucose monitor

    Dexcom G6 CGM system

06

What researchers measure

Primary outcomes

  1. Glycemic variability

    % coefficient of variation on blinded CGM

    Time frame: 16 weeks

Secondary outcomes

  1. percent time in range

    percent time 3.9-10 mmol/l on CGM

    Time frame: week 16 and 26

  2. percent time below range

    percent time below 3.9 mmol/l and below 3.0 mmol/l

    Time frame: week 16 and 26

  3. percent time above range

    percent time above 10 mmol/l and 13.9 mmol/l

    Time frame: week 16 and 26

  4. HbA1c

    HbA1c

    Time frame: week 16 and 26

  5. Self reported hypoglycemia

    level 1,2 and 3 hypoglycemia, biochemically confirmed

    Time frame: 26 weeks

  6. Self monitored glucose profiles

    Fasting and postprandial

    Time frame: 26 weeks

  7. Body weight

    Body weight

    Time frame: week 16 and 26

  8. Insulin doses

    Insulin doses

    Time frame: week 16 and 26

  9. eGFR

    estimated glomerular filrate rate by CKD-EPI equation

    Time frame: week 16 and 26

  10. uACR

    urine albumin creatinine ratio

    Time frame: week 16 and 26

  11. Diabetes Treatment Satisfaction

    Chinese version of Diabetes Treatment Satisfaction Questionnaire, higher score better

    Time frame: week 16 and 26

07

Study locations

1 site
  • Prince of Wales Hospital
    Shatin, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05218915
Lead sponsor
Elaine Chow
Responsible party
Elaine Chow (Clinical Assistant Professor, Chinese University of Hong Kong) — Sponsor-investigator
First posted
Feb 1, 2022
Start date
Jan 28, 2022
Primary completion
Oct 30, 2024
Completion
Oct 30, 2024
Last update
Dec 3, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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