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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
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 18-40•HbA1c 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
1 endpointBody weight
Time frame:week 16 and 26
descriptive, improvement
Glycemic / diabetes
7 endpointsGlycemic variability
Time frame:16 weeks
descriptive, improvement
percent time in range
Time frame:week 16 and 26
CGM time-in-range
percent change from baseline, improvement
percent time below range
Time frame:week 16 and 26
CGM time-below-range
percent change from baseline, improvement
percent time above range
Time frame:week 16 and 26
CGM time-above-range
percent change from baseline, improvement
HbA1c
Time frame:week 16 and 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Self monitored glucose profiles
Time frame:26 weeks
descriptive
Insulin doses
Time frame:week 16 and 26
descriptive
Renal / kidney
2 endpointseGFR
Time frame:week 16 and 26
eGFR, change
change from baseline, improvement
LOINC 98979-8
uACR
Time frame:week 16 and 26
uACR, change
ratio, improvement
LOINC 9318-7
Patient-reported / QoL
1 endpointDiabetes Treatment Satisfaction
Time frame:week 16 and 26
descriptive, improvement
Safety / tolerability / PK
1 endpointSelf reported hypoglycemia
Time frame:26 weeks
Documented hypoglycemia
event count, event
Provenance
Sources
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.