Current partner codePEPTIDESDE
NCT05218915·Phase 4·INTERVENTIONAL

Basal Plus GLP1-ra on Glycemic Variability in CKD

Status

Completed

Phase

Phase 4

Enrollment

95

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Dulaglutide

Dulaglutide once weekly subcutaneous

DRUG

Insulin Degludec

Insulin degludec once daily

DEVICE

Continuous glucose monitor

Dexcom G6 CGM system

Timeline

From registration to results.

  1. First posted

    Feb 1, 2022

  2. Study start

    Jan 28, 2022

  3. Primary completion

    Oct 30, 2024

  4. Study completion

    Oct 30, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Dec 3, 2024

Outcomes

What the study measures.

Primary outcomes

Glycemic variability

Time frame · 16 weeks

% coefficient of variation on blinded CGM

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
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).

Study locations

1 registered sites.

Hong Kong. Showing up to 24 locations stored in the fast local snapshot.

Prince of Wales Hospital

Shatin, Hong Kong

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

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