Basal Plus GLP1-ra on Glycemic Variability in CKD

Phase 4

Completed

• Conditions: Diabetic Kidney Disease; Diabetes Mellitus
• Interventions: Drug: Dulaglutide; Drug: Insulin Degludec; Device: Continuous glucose monitor

• Registration Number: NCT05218915
• Lead Sponsor: Elaine Chow

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study Start: 2022-01-28
• Study First Posted: 2022-02-01
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLP1-ra plus basal insulin (BGLP)	Continuous glucose monitor	Dulaglutide and insulin degludec in combination with CGM
Basal bolus insulin (BB)	Continuous glucose monitor	Insulin aspart/lispro and insulin degludec in combination with CGM
GLP1-ra plus basal insulin (BGLP)	Dulaglutide	Dulaglutide and insulin degludec in combination with CGM
GLP1-ra plus basal insulin (BGLP)	Insulin Degludec	Dulaglutide and insulin degludec in combination with CGM
Basal bolus insulin (BB)	Insulin Degludec	Insulin aspart/lispro and insulin degludec in combination with CGM

Primary Outcome Measures

Name	Time	Method
Glycemic variability	16 weeks	% coefficient of variation on blinded CGM

Secondary Outcome Measures

Name	Time	Method
percent time below range	week 16 and 26	percent time below 3.9 mmol/l and below 3.0 mmol/l
HbA1c	week 16 and 26	HbA1c
Diabetes Treatment Satisfaction	week 16 and 26	Chinese version of Diabetes Treatment Satisfaction Questionnaire, higher score better
percent time in range	week 16 and 26	percent time 3.9-10 mmol/l on CGM
percent time above range	week 16 and 26	percent time above 10 mmol/l and 13.9 mmol/l
Self monitored glucose profiles	26 weeks	Fasting and postprandial
Body weight	week 16 and 26	Body weight
Insulin doses	week 16 and 26	Insulin doses
eGFR	week 16 and 26	estimated glomerular filrate rate by CKD-EPI equation
uACR	week 16 and 26	urine albumin creatinine ratio
Self reported hypoglycemia	26 weeks	level 1,2 and 3 hypoglycemia, biochemically confirmed

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong