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Trial · Interventional

CompletedPhase 4Registry data

Basal 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
2022202320242025
  1. Ph 4

    Basal Plus GLP1-ra on Glycemic Variability in CKD

    NCT05218915

    28 Jan 2022 to 30 Oct 2024

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.

  1. Glycemic variability

    Time frame · 16 weeks

    Registry description

    % coefficient of variation on blinded CGM

Secondary outcomes(11)
  1. percent time in range

    Time frame · week 16 and 26

    Registry description

    percent time 3.9-10 mmol/l on CGM

  2. 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

  3. percent time above range

    Time frame · week 16 and 26

    Registry description

    percent time above 10 mmol/l and 13.9 mmol/l

  4. HbA1c

    Time frame · week 16 and 26

    Registry description

    HbA1c

  5. Self reported hypoglycemia

    Time frame · 26 weeks

    Registry description

    level 1,2 and 3 hypoglycemia, biochemically confirmed

  6. Self monitored glucose profiles

    Time frame · 26 weeks

    Registry description

    Fasting and postprandial

  7. Body weight

    Time frame · week 16 and 26

    Registry description

    Body weight

  8. Insulin doses

    Time frame · week 16 and 26

    Registry description

    Insulin doses

  9. eGFR

    Time frame · week 16 and 26

    Registry description

    estimated glomerular filrate rate by CKD-EPI equation

  10. uACR

    Time frame · week 16 and 26

    Registry description

    urine albumin creatinine ratio

  11. 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
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).

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