Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

The main purpose of this study is to evaluate whether saxagliptin or (and vitamin D3) with metformin (and insulin) therapy can better protect islet β cell function than metformin(and insulin) .

It had three arms (groups): Metformin (and insulin) + saxagliptin (experimental), Metformin(insulin)+saxagliptin +vitamin D3 (experimental) and Metformin (and insulin) (active comparator).

The registry classes the interventions as drug.

More on the Plan

LADA is actually a form of type 1 diabetes, which is caused by autoimmune damage of islet β cells and triggered by environmental factors based on genetic susceptibility.

LADA shows some characteristics of type 2 diabetes at its onset, which develops slowly and latent, and easily be misdiagnosed as type 2 diabetes due to slowly β cell function deterioration.

This is a multi-center, open- label, 1:1:1 randomized controlled trial to investigate the protective effects of saxagliptin and vitamin D3 in LADA patients.

The study comprises the 0-6weeks of screening period and the 104-week intervention period.

Who Took Part

The registry lists 300 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Volunteer to participate in the study with informed consent;. The LADA patients to be included in this study are defined as:.

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: pregnancy, breastfeeding or planned pregnancy within two years;; gestational diabetes mellitus or other specific types of diabetes;; allergic to saxagliptin, vitamin d3 and their excipient;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2015-03 with completion listed for 2020-12-30.

It ran at 39 sites in China (39).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Absolute changes from baseline in Fasting C-peptide levels at week 104 (time frame: From baseline to 104 week).

It also tracked 9 secondary outcomes, for example Absolute changes from baseline in fasting C-peptide levels and at week 26, 52 and 78, Absolute changes from baseline in C peptide at 60-min and 120-min (AUC) during a mixed-meal tolerance test and at week 26, 52, 78 and 104, Changes of HbA1c levels from baseline and at week 26, 52, 78 and 104, Changes of GADA titers from baseline and at week 52 and 104 and Absolute changes of body weight and BMI level from baseline and at week 26, 52, 78 and 104.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 300 people.

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

More context: the Insulin (regular human) compound page, all human trials.