Basal Plus GLP1-ra on Glycemic Variability in CKD

NCT05218915 | Completed Phase 4 DMC FDA Device

• 1 other identifier: BGLP-DKD
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes Mellitus; Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Glycemic variability

  % coefficient of variation on blinded CGM

  16 weeks

Secondary Outcomes (11)

• percent time in range

  week 16 and 26

• percent time below range

  week 16 and 26

• percent time above range

  week 16 and 26

• HbA1c

  week 16 and 26

• Self reported hypoglycemia

  26 weeks

Study Arms (2)

GLP1-ra plus basal insulin (BGLP)

EXPERIMENTAL

Dulaglutide and insulin degludec in combination with CGM

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

Drug: Insulin Degludec; Device: Continuous glucose monitor

Interventions

Dulaglutide DRUG

Dulaglutide once weekly subcutaneous

GLP1-ra plus basal insulin (BGLP)

Insulin Degludec DRUG

Insulin degludec once daily

Basal bolus insulin (BB); GLP1-ra plus basal insulin (BGLP)

Continuous glucose monitor DEVICE

Dexcom G6 CGM system

Basal bolus insulin (BB); GLP1-ra plus basal insulin (BGLP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Elaine Chow: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Nephropathies

Interventions

dulaglutide; insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: January 28, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)