Trial · Interventional
CompletedPhase 4Registry dataBasal Plus GLP1-ra on Glycemic Variability in CKD
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 95 participants (actual)
- Sponsor
- Elaine Chow · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Hong Kong
- Start
- 28 Jan 2022
- Primary completion
- 30 Oct 2024
- Completion
- 30 Oct 2024
- First posted
- 1 Feb 2022
- Last update posted
- 3 Dec 2024
- Conditions
- Diabetes Mellitus · Diabetic Kidney Disease
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
- DulaglutideDrug
- Insulin DegludecDrug
- Continuous glucose monitorDevice
Arms2
Experimental
GLP1-ra plus basal insulin (BGLP)
Dulaglutide and insulin degludec in combination with CGM
Active comparator
Basal bolus insulin (BB)
Insulin aspart/lispro and insulin degludec in combination with CGM
Primary outcomes1
Outcomes the sponsor listed as primary.
Glycemic variability
Time frame · 16 weeks
Registry description
% coefficient of variation on blinded CGM
Secondary outcomes(11)
percent time in range
Time frame · week 16 and 26
Registry description
percent time 3.9-10 mmol/l on CGM
percent time below range
Time frame · week 16 and 26
Registry description
percent time below 3.9 mmol/l and below 3.0 mmol/l
percent time above range
Time frame · week 16 and 26
Registry description
percent time above 10 mmol/l and 13.9 mmol/l
HbA1c
Time frame · week 16 and 26
Registry description
HbA1c
Self reported hypoglycemia
Time frame · 26 weeks
Registry description
level 1,2 and 3 hypoglycemia, biochemically confirmed
Self monitored glucose profiles
Time frame · 26 weeks
Registry description
Fasting and postprandial
Body weight
Time frame · week 16 and 26
Registry description
Body weight
Insulin doses
Time frame · week 16 and 26
Registry description
Insulin doses
eGFR
Time frame · week 16 and 26
Registry description
estimated glomerular filrate rate by CKD-EPI equation
uACR
Time frame · week 16 and 26
Registry description
urine albumin creatinine ratio
Diabetes Treatment Satisfaction
Time frame · week 16 and 26
Registry description
Chinese version of Diabetes Treatment Satisfaction Questionnaire, higher score better
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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