Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with oral drugs and the other is continuous subcutaneous insulin injection.

It had two arms (groups): GROUP A (active comparator) and GROUP B (experimental).

The registry classes the interventions as drug.

More on the Plan

This study was a single-center, randomized, controled and prospective trial.

Type 2 diabetic patients were randomized into 2 groups (Group A and Group B).

Subjects in group A would be treated by using continuous subcutaneous insulin injection with insulin lispro, while subjects in group B would be treated by using glargine with oral drugs (metformin and gliclazide modified release tablets).

After achieving the target glucose levels by two different approaches in 3-5 days, maintain the target glucose level for 3-5 days.

Who Took Part

The registry lists 70 planned participants were the target.

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: Investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria). Agree to participate the study and sign the informed consent.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: obvious failure of heart, hepatic, kidney function; severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug; women in pregnancy or planning to get pregnancy.

How the Study Was Run

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

Because people in this Insulin Glargine 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.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2015-07 with completion listed for 2016-08.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: mean amplitude of glycemic excursions( MAGE) (time frame: 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days).

It also tracked 13 secondary outcomes, for example glycated hemoglobin A1c, glycated albumin, fasting plasma glucose, postprandial plasma glucose (30min, 120min), Fasting C-peptide, Fasting insulin and Homa-β.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 70 people.

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

More context: the Insulin Glargine compound page and the Insulin Lispro compound page, all human trials.