Metformin Plus Insulin on Non-obese Autoimmune Diabetes

What Was Tested

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

The objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.

It had two arms (groups): Metformin + Insulin (experimental) and Insulin alone (active comparator).

The registry classes the interventions as drug.

Who Took Part

15 planned participants were the target.

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: Type 1 diabetes according to ADA criterias \<5 years. Age≥ 18 years and less than 70 years. Non-obese: defined as BMI less than 28 kg/m2. Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A. Written informed consent from the patient or family representative.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: history of any malignancy or other severe diseases; female patients who are pregnant or breastfeeding before or during the three-year follow-up; poor compliance or refusal to participate.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-08-01 with completion listed for 2020-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean amplitude of glycemic excursions (MAGE) (time frame: 6 months). Change in C-peptide (time frame: 6 months).

It also tracked 5 secondary outcomes, for example Change in HbA1c, Change in body mass index (BMI), Change in lipid profiles and Adverse effects.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 15 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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