The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

The investigators intends to carry out a randomized, cross-over, prospective study which will last 48 weeks in youth with T1DM followed up by the center.

The purpose is to observe the effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.

It had two arms (groups): Metformin and Insulin (other) and Insulin (other).

Accept insulin for 24 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 actual participants took part.

It was open to people of any sex aged from 12 years with no upper age limit.

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

Examples of who could join: Type 1 diabetes mellitus;. Tanner sexual maturation rating 2-5;. MDI or CSII ≥6 months;.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: repeated and serious hypoglycemia episodes repeatedly;; hepatic function damage (alt≥2.5 times higher than the upper limit of the normal accepted range);; female patients who have a sex life and are not willing to use contraceptive methods;.

How the Study Was Run

It was run as a randomized, crossover 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.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

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

It started in 2016-06 with completion listed for 2018-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c (time frame: half one year).

What This Means in Plain Language

Put simply, this is a phase 4, 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.