Clinical trial NCT05218915: Basal Plus GLP1-ra on Glycemic Variability in CKD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Diabetic Kidney Disease
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).

Primary outcomes:
measure: Glycemic variability
timeFrame: 16 weeks
Secondary outcomes:
measure: percent time in range
timeFrame: week 16 and 26
measure: percent time below range
timeFrame: week 16 and 26
measure: percent time above range
timeFrame: week 16 and 26
measure: HbA1c
timeFrame: week 16 and 26
measure: Self reported hypoglycemia
timeFrame: 26 weeks
measure: Self monitored glucose profiles
timeFrame: 26 weeks
measure: Body weight
timeFrame: week 16 and 26
measure: Insulin doses
timeFrame: week 16 and 26
measure: eGFR
timeFrame: week 16 and 26
measure: uACR
timeFrame: week 16 and 26
measure: Diabetes Treatment Satisfaction
timeFrame: week 16 and 26
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: