Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients With Type 2 Diabetes Mellitus

What Was Tested

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

The study will assess the glycemic variationusing continuous glucose monitoring system in type 2 diabetic patients with euglycemia control respectively when patients was treated with Basalin and one week after changing the insulin into Lantus.

It had 1 arm (groups): Basalin to Lantus (experimental).

The patients who are using Basalin treatment will use isodose of Lantus instead.

The registry classes the interventions as drug.

More on the Plan

The participants will take continuous glucose monitoring system for 3 days when they change the insulin into Lantus after reach euglycemia control with Basalin treatment for one week.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex.

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

Examples of who could join: Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;. Patients had relatively constant diet and exercise in 2 month before the study.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;; patients with severe infectious diseases;; patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;.

How the Study Was Run

The set-up was single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-08-15 with completion listed for 2018-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change of glycemic variation (time frame: Day 1-13).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine in 100 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, all human trials.