DRUG
Dulaglutide
Dulaglutide once weekly subcutaneous
Status
Completed
Phase
Phase 4
Enrollment
95
Locations
1
Results
Not posted
Publications
0
Study 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
DRUG
Dulaglutide once weekly subcutaneous
DRUG
Insulin degludec once daily
DEVICE
Dexcom G6 CGM system
Timeline
First posted
Feb 1, 2022
Study start
Jan 28, 2022
Primary completion
Oct 30, 2024
Study completion
Oct 30, 2024
Results posted
Not reported
Registry updated
Dec 3, 2024
Outcomes
Glycemic variability
Time frame · 16 weeks
% coefficient of variation on blinded CGM
percent time in range
Time frame · week 16 and 26
percent time 3.9-10 mmol/l on CGM
percent time below range
Time frame · week 16 and 26
percent time below 3.9 mmol/l and below 3.0 mmol/l
percent time above range
Time frame · week 16 and 26
percent time above 10 mmol/l and 13.9 mmol/l
HbA1c
Time frame · week 16 and 26
HbA1c
Self reported hypoglycemia
Time frame · 26 weeks
level 1,2 and 3 hypoglycemia, biochemically confirmed
Self monitored glucose profiles
Time frame · 26 weeks
Fasting and postprandial
Body weight
Time frame · week 16 and 26
Body weight
Insulin doses
Time frame · week 16 and 26
Insulin doses
eGFR
Time frame · week 16 and 26
estimated glomerular filrate rate by CKD-EPI equation
uACR
Time frame · week 16 and 26
urine albumin creatinine ratio
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).
Study locations
Hong Kong. Showing up to 24 locations stored in the fast local snapshot.
Prince of Wales Hospital
Shatin, Hong Kong
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Ohio State University · Obesity & Overweight · Diabetes (DM)
Not applicable
Recruiting
300
2026-07
Eli Lilly · Type 2 Diabetes
Phase 3
Recruiting
55
2026-07
Eli Lilly · Diabetes Mellitus, Type 2
Phase 3
Not yet recruiting
170
2026-07
Brigham and Women's Hospital · Type 2 Diabetes
Not applicable
Completed
300,000
2026-07
Brigham and Women's Hospital · Type 2 Diabetes · Overweight
Not applicable
Completed
60,000
2026-07
Brigham and Women's Hospital · Type 2 Diabetes Mellitus · Obesity
Not applicable
Completed
120,000
2026-07
Eli Lilly · Type 2 Diabetes Mellitus
Phase 3
Completed
13,299
2026-07
ProGen. Co., Ltd. · Type 2 Diabetes
Phase 2
Not yet recruiting
60
2026-07
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.