Basal Plus GLP1-ra on Glycemic Variability in CKD

What Was Tested

The trial (phase 4) is built around Dulaglutide.

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.

It had two arms (groups): GLP1-ra plus basal insulin (BGLP) (experimental) and Basal bolus insulin (BB) (active comparator).

Dulaglutide and insulin degludec in combination with CGM.

Insulin aspart/lispro and insulin degludec in combination with CGM.

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 95 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study. 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.

The full record lists 10 inclusion and 13 exclusion criteria; among the exclusions: type 1 diabetes; 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.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

The Dulaglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Dulaglutide study did not mask who received what.

It started in 2022-01-28 with completion listed for 2024-10-30.

It ran at 1 site in Hong Kong.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glycemic variability (time frame: 16 weeks).

It also tracked 11 secondary outcomes, for example percent time in range, percent time below range, percent time above range, HbA1c, Self reported hypoglycemia and Self monitored glucose profiles.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 95 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.