Protective Effects of Sitagliptin on β Cell Function in Patients With Adult-onset Latent Autoimmune Diabetes (LADA)

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): Sitagliptin (experimental) and Insulin (active comparator).

Patients will receive insulin therapy with sitagliptin.

Patients will receive insulin therapy without sitagliptin.

The registry classes the interventions as drug.

More on the Plan

Besides the β cell function, another important target is insulin sensitivity.

The researchers'd like to further explore the possible effect of sitagliptin on insulin sensitivity in LADA patients by homeostasis model assessment for insulin resistance (HOMA-IR) index and euglycemic clamp technique.

Hence, the researchers aim to explore the effects of sitagliptin plus insulin on β cell function, insulin sensitivity, pro-inflammatory cytokines and immune regulation including Teff and Treg frequency, and function in patients with LADA.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 25 years up to 70 years.

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

Examples of who could join: Age at onset between 25\~70 years. Disease duration of less than 3 year. GADA positive twice within one month.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: evidence of chronic infection or acute infection affected blood glucose control within 4 weeks prior to visit 1; history of any malignancy; pregnancy, breastfeeding or planned pregnancy within two years.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2010-01 with completion listed for 2012-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The effects of sitagliptin on β cell function and insulin sensitivity of LADA patients (time frame: 2 years).

It also tracked 5 secondary outcomes, for example The possible immunomodulatory effects of sitagliptin on LADA patients, The possible immunomodulatory effects of sitagliptin on LADA patients, The possible immunomodulatory effects of sitagliptin on LADA patients, The possible immunomodulatory effects of sitagliptin on LADA patients and The possible immunomodulatory effects of sitagliptin on LADA patients.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) in 30 people.

Its size is small, so on its own it can only give an early look.

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.