Diabetes Mellitus, Diabetic Kidney Disease
Conditions
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
Interventions
DRUGDulaglutide
Dulaglutide once weekly subcutaneous
DRUGInsulin Degludec
Insulin degludec once daily
DEVICEContinuous glucose monitor
Dexcom G6 CGM system
Sponsors
Elaine Chow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic variability | 16 weeks | % coefficient of variation on blinded CGM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percent time below range | week 16 and 26 | percent time below 3.9 mmol/l and below 3.0 mmol/l |
| percent time above range | week 16 and 26 | percent time above 10 mmol/l and 13.9 mmol/l |
| HbA1c | week 16 and 26 | HbA1c |
| Self reported hypoglycemia | 26 weeks | level 1,2 and 3 hypoglycemia, biochemically confirmed |
| Self monitored glucose profiles | 26 weeks | Fasting and postprandial |
| percent time in range | week 16 and 26 | percent time 3.9-10 mmol/l on CGM |
| 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 |
| Diabetes Treatment Satisfaction | week 16 and 26 | Chinese version of Diabetes Treatment Satisfaction Questionnaire, higher score better |
| Body weight | week 16 and 26 | Body weight |
Countries
Hong Kong
Outcome results
None listed