← Trials/Trial dossier/NCT05218915

CompletedPhase 4

Basal Plus GLP1-ra on Glycemic Variability in CKD

Effect of Glucagon-like Peptide 1 Receptor Agonist in Combination with Insulin on Glycaemic Variability and Time-in-range in Diabetic Kidney Disease: a Randomised Controlled Trial

Lead sponsor

Elaine Chow

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

95

actual

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

BMI 18-40HbA1c 6.5-9%eGFR 15-59

Primary endpoint

Glycemic variability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05218915
Org study IDBGLP-DKD

Timeline

Milestones

Study start2022-01-28actual
Study first posted2022-02-01actual
Primary completion2024-10-30actual
Study completion2024-10-30actual
Last update posted2024-12-03actual

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

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).

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
7
Renal / kidney
2
Weight & body composition
1
Patient-reported / QoL
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Body weight

Time frame:week 16 and 26

descriptive, improvement

Glycemic / diabetes

7 endpoints
Primary/protocol endpoint

Glycemic variability

Time frame:16 weeks

descriptive, improvement

Secondary/protocol endpoint

percent time in range

Time frame:week 16 and 26

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

percent time below range

Time frame:week 16 and 26

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

percent time above range

Time frame:week 16 and 26

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

HbA1c

Time frame:week 16 and 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Self monitored glucose profiles

Time frame:26 weeks

descriptive

Secondary/protocol endpoint

Insulin doses

Time frame:week 16 and 26

descriptive

Renal / kidney

2 endpoints
Secondary/protocol endpoint

eGFR

Time frame:week 16 and 26

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

uACR

Time frame:week 16 and 26

uACR, change

ratio, improvement

LOINC 9318-7

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Diabetes Treatment Satisfaction

Time frame:week 16 and 26

descriptive, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Self reported hypoglycemia

Time frame:26 weeks

Documented hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.