Diabetes MellitusPhase 4NCT05218915
Basal Plus GLP1-ra on Glycemic Variability in CKD
A Phase 4 study testing Dulaglutide, Insulin Degludec and Continuous glucose monitor in people with Diabetes Mellitus and Diabetic Kidney Disease, run by Elaine Chow at 1 site in Hong Kong.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Kidney Disease
- What is being tested?
- Dulaglutide, Insulin Degludec and Continuous glucose monitor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Jan 2022to 30 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus diagnosed for at least 6 months
- Male or female age ≥ 18 years old and ≤ 75 years old.
- Body mass index between 18 and 40 kg/m2 inclusive
- HbA1c ≥ 6.5% and ≤ 9.0% at screening
- Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
- 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
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- 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.
- 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.
- Written informed consent to participate in the study provided by the patient.
- Willing and capable of use of a continuous glucose monitor as judged by the investigator
Who cannot join
- Type 1 diabetes
- Currently pregnant, as demonstrated by a positive pregnancy test at screening or planning pregnancy
- Treatment with GLP-1 RA or insulin degludec in the past three months
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
- 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.
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- 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).
- Have a known allergy to medical-grade adhesives
- Known current or recent alcohol or drug abuse
- Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction in the six months prior to screening
- Patients on renal replacement therapy or likely require kidney transplant or dialysis during the study period
- Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
- An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Diabetes Mellitus, Diabetic Kidney Disease
- Being tested
- Dulaglutide, Insulin Degludec, Continuous glucose monitor
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
Dulaglutide once weekly subcutaneous
Insulin DegludecDrug
Insulin degludec once daily
Continuous glucose monitorDevice
Dexcom G6 CGM system
| Study group | Role | What they receive |
|---|---|---|
| GLP1-ra plus basal insulin (BGLP) | Experimental | Dulaglutide and insulin degludec in combination with CGM Receives: Drug: Dulaglutide; Drug: Insulin Degludec; Device: Continuous glucose monitor |
| Basal bolus insulin (BB) | Active comparator | Insulin aspart/lispro and insulin degludec in combination with CGM Receives: Drug: Insulin Degludec; Device: Continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic variability
% coefficient of variation on blinded CGM
Measured: 16 weeks
Secondary outcomes (11)
percent time in range
percent time 3.9-10 mmol/l on CGM
Measured: week 16 and 26
percent time below range
percent time below 3.9 mmol/l and below 3.0 mmol/l
Measured: week 16 and 26
percent time above range
percent time above 10 mmol/l and 13.9 mmol/l
Measured: week 16 and 26
HbA1c
HbA1c
Measured: week 16 and 26
Self reported hypoglycemia
level 1,2 and 3 hypoglycemia, biochemically confirmed
Measured: 26 weeks
Self monitored glucose profiles
Fasting and postprandial
Measured: 26 weeks
Body weight
Body weight
Measured: week 16 and 26
Insulin doses
Insulin doses
Measured: week 16 and 26
eGFR
estimated glomerular filrate rate by CKD-EPI equation
Measured: week 16 and 26
uACR
urine albumin creatinine ratio
Measured: week 16 and 26
Diabetes Treatment Satisfaction
Chinese version of Diabetes Treatment Satisfaction Questionnaire, higher score better
Measured: week 16 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start28 Jan 2022
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elaine Chow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elaine Chow, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218915
- Sponsor's protocol ID
- BGLP-DKD
- Status last verified
- Nov 2024
- First submitted
- 20 Jan 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05218915
- Acronym / sponsor ID
- BGLP-DKD
- Conditions
- Diabetes Mellitus, Diabetic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Elaine ChowUniversity, hospital or other
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP1-ra plus basal insulin (BGLP) | Experimental | Drug: Dulaglutide, Drug: Insulin Degludec, Device: Continuous glucose monitorDulaglutide and insulin degludec in combination with CGM |
| Basal bolus insulin (BB) | Active comparator | Drug: Insulin Degludec, Device: Continuous glucose monitorInsulin aspart/lispro and insulin degludec in combination with CGM |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Type 2 diabetes mellitus diagnosed for at least 6 months
- Male or female age ≥ 18 years old and ≤ 75 years old.
- Body mass index between 18 and 40 kg/m2 inclusive
- HbA1c ≥ 6.5% and ≤ 9.0% at screening
- Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
Key exclusion criteria (13 listed)
- Type 1 diabetes
- Currently pregnant, as demonstrated by a positive pregnancy test at screening or planning pregnancy
- Treatment with GLP-1 RA or insulin degludec in the past three months
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DulaglutideDulaglutide once weekly subcutaneous | Drug | GLP1-ra plus basal insulin (BGLP) |
| Insulin DegludecInsulin degludec once daily | Drug | Basal bolus insulin (BB), GLP1-ra plus basal insulin (BGLP) |
| Continuous glucose monitorDexcom G6 CGM system | Device | Basal bolus insulin (BB), GLP1-ra plus basal insulin (BGLP) |
Primary outcome
Glycemic variability
Time frame: 16 weeks
% coefficient of variation on blinded CGM
11 secondary outcomes
percent time in range
Time frame: week 16 and 26
percent time below range
Time frame: week 16 and 26
percent time above range
Time frame: week 16 and 26
HbA1c
Time frame: week 16 and 26
Self reported hypoglycemia
Time frame: 26 weeks
Self monitored glucose profiles
Time frame: 26 weeks
Body weight
Time frame: week 16 and 26
Insulin doses
Time frame: week 16 and 26
eGFR
Time frame: week 16 and 26
uACR
Time frame: week 16 and 26
Diabetes Treatment Satisfaction
Time frame: week 16 and 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dulaglutide, Insulin Degludec and Continuous glucose monitor in people with Diabetes Mellitus and Diabetic Kidney Disease, run by Elaine Chow at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic variability (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.