Basal Plus GLP1-ra on Glycemic Variability in CKD

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218915
• Other study ID #: BGLP-DKD
• Status: Recruiting
• Phase: Phase 4
• Start date: January 28, 2022
• Est. completion date: January 3, 2025

Study information

• Verified date: November 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 3, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Dulaglutide
Dulaglutide once weekly subcutaneous
• Insulin Degludec
Insulin degludec once daily

Device:
• Continuous glucose monitor
Dexcom G6 CGM system

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Elaine Chow

Country where clinical trial is conducted

Hong Kong, 

Outcome

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